Monday, April 30, 2018

Leistritz to Host Pharmaceutical-Nutraceutical Extrusion Seminar

Leistritz announced its Pharmaceutical-Nutraceutical Extrusion Seminar will take place on June 6–7, 2018. The two-day event will focus on the latest melt extrusion and granulation technologies for pharmaceutical and nutraceutical products and will include classroom sessions at the Holiday Inn in Clinton, NJ, and extrusion demonstrations at the nearby Leistritz Process Laboratory in Somerville, NJ.

Day-one seminar topics include:

  • “Twin Screw Extrusion Theory, Tips and Test Results” with Charlie Martin, Leistritz
  • “Twin Screw Design, Processing Guidelines, and Scale-Up” with Bill Thiele, Leistritz
  • “Developments in Twin Screw Granulation” with Mike Thompson, McMaster University
  • “Hot-Melt Extrusion Viewed as a Special Polymer Compounding” with Costas Gogos, Polymer Processing Institute
  • “Downstream Extrusion Equipment for Processing Shape Extrusions in Pharmaceutical Applications” with Bob Bessemer, Conair Group
  • “Continuous Twin-Screw Melt Granulation of Thermally Labile Drug/Case Study” with Tony Listro, Foster Delivery Science.

Live demonstrations at the Leistritz laboratory will showcase:

  • Nano-16 twin screw extrusion system processing 50-gram batch samples
  • Film/lamination extrusion system as used for transdermal or dissolvable film applications
  • Melt extrusion of poorly soluble active ingredients
  • Foaming of an extrudate via sCO2 injection
  • Wet and melt granulation.

Day-two seminar topics include: 

  • “Design and Application of Twin Screw Extruder Elements” with Brian Haight, Leistritz
  • “Understanding the Extrusion Design Space of HPMCAS” with Kevin O’Donnell, Dow Food, Pharma & Medical
  • “Industrial Pharmaceutical Application Converting a Fluid Bed Granulation Process to Twin Screw Wet Granulation” with Crystal Miranda, Merck
  • “Polymers Meeting the Challenges with Poorly Soluble APIs by HME” with Shaukat Ali, BASF
  • “Solubility Enhancement and Targeted Delivery Using Eudragit and Eudraguard for Active Pharmaceutical Ingredients and Dietary Supplements” with Firouz Asgarzadeh, Evonik
  • “Twin Screw Granulation: A Case Study for Enabling an Adaptive Study Plan” with Steve Pafiakis, Bristol-Myers Squibb
  • “Stabilizing Meloxicam During Twin Screw Extrusion” with Abbe Hasar, Merck
  • “Granulation Technologies, Developments and Applications” with Tom Durig, Ashland Specialty Ingredients
  • “Die and Downstream Extrusion Techniques” with Augie Machado, Leistritz
  • “Cleaning and Validation of Extrusion Equipment” with Bert Elliott, Leistritz
  • “Control Systems for Pharma Extrusion” with Pete Palmer, Wolock & Lott
  • Interactive screw assembly/design demonstration.

In addition to the presentation materials, attendees will receive a copy of the recently published second edition of the Pharmaceutical Extrusion Technology textbook.

For more information, contact Sarah Scovens, e-mail [email protected], 908.685.2333, x614.

Source: Leistritz

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Friday, April 27, 2018

Understanding Validation and Technical Transfer, Part 2

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.

Wright Studio/Shutterstock.com

This second installment in a three-part series on validation and technical transfer in the biopharmaceutical industry presents a generalized example that shows how a validation plan might be developed to support a process. While the example is not related to biopharmaceutical manufacture, it demonstrates various points to consider related to the inputs, the processing system, and the outputs that can be applied to biopharmaceutical processes and systems. The intent is to think outside the box and avoid terminology traps that hinder many validation efforts. 

Part 1 of this series, which appeared in the April 2018 issue of this publication, contained a brief history of validation and defined the terms process and validation to provide context (1).
 

An Example

Let’s say one is about to open a coffee shop and wants to ensure its success. The process to be validated is coffee-brewing. The goal is to consistently produce good tasting coffee. For the sake of simplicity, no specialty coffee (e.g., latte, cappuccino) is considered and no cream, sugar, or flavoring is added to the brewed coffee. The process is described as the following:

  • Inputs include water and coffee.
  • The processing system is the coffee brewer and the coffee grinder.
  • The outputs are brewed coffee and process waste: coffee grounds and used filters.

The process seems simple enough, but to begin with the end in mind, it is important to define good-tasting coffee. A controlled, double-blind study should be conducted to determine which coffee the majority of 
tasters prefer to obtain a definition of “good-tasting coffee.” To have a meaningful result, the brewed coffee used in the study must be produced in some standardized way not only to achieve reproducible tasting results but to enable the ultimately chosen brewing process to be validated and to produce coffee equivalent to that used in the tasting study. The obvious analogy is a clinical trial followed by subsequent commercial-scale production of a biopharmaceutical product.

The process inputs are water and coffee; but what type of coffee is selected and how is it roasted and ground? Should the coffee be a blend, or should it be a single type? If a blend is desired, what types should be used and in what proportion? Should the coffee be sourced from various growing regions or should it be single-sourced? What level of roast should be used: light, medium, dark? How will the roasting be controlled? How will the beans be ground, and to what degree? Should there be a maximum time allowed between grinding and brewing? Will tap water be used, or should some form of processed or filtered water be considered? These decisions impact the process and must be carefully considered. Some process variables are more critical than others.

Even in this simple example, there are many factors to consider, and biopharmaceutical processing is much more complex. An Ishikawa (fishbone) diagram is a helpful tool for visualizing processes and process inputs. 
Figure 1 is an example applied to coffee brewing.

Figure 1. Fishbone diagram of a simplified coffee-brewing process.

Once the decisions have been made with respect to the coffee and water, supported by evidence from the tasting trials, the brewing process can be considered. Data from how the coffee used in the tasting studies was prepared serve as the basis for developing and validating the brewing process. Wherever possible, quantitative values should be established and documented so they can be used for process execution and further evaluation. Equipment make, type, model, and serial number should be documented.

The brewing process must be carefully assessed before validation can begin. What brewing process will be used—percolation, drip, vacuum, or French press? Assuming the coffee type and grind have been determined, what brewing ratio, coffee-to-water, will be used? How long will the brewing cycle be? How will it be timed? What water temperature will be used, and when and how will that temperature be measured and controlled? What, if any, type of filter is employed? How will the brewing equipment be cleaned and when? Will detergents be used? If so, what duration and type of rinsing will be used to remove detergent residues?

The coffee brewed for the tasting studies will have been prepared in some controlled manner using identifiable coffee type, roast, and grind, and processed in equipment that will serve as the basis for selecting equipment for the commercial brewing process. Once the choice of equipment has been finalized, the equipment must be qualified with respect to its operational parameters. What brew settings are available? Which ones have a critical impact on the taste of the brewed coffee? How reproducible are the settings, and how accurate? With respect to the coffee grinder, how is the fineness of the grind determined and set? How reproducible are the settings? What is the uniformity of the grind? Does it contain a high proportion of “fines” or large particles? What are the capacities of the brewer and grinder and do they match the expected coffee shop volume?
Finally, the process output must be examined and evaluated. Does the brewed coffee taste good? How will that be determined? Is it the same as the coffee chosen as a result of the taste testing? Are there any analytical methods that might provide confirmation? At what temperature should the coffee be held, and for how long? How should it be served, in a paper cup, foam cup, or china? Does the cup require insulation? Will take-out be available? If reusable, how will the cups be washed? Are coffee stains or detergent residue issues?
Once these variables have been defined, examined, and evaluated, the validation study can begin. A single validation protocol can cover the entire process or, more usefully, the process can be broken down into several manageable steps with individual protocols for each.

Validation Protocols

Validation protocols should describe the intended process, define the acceptance criteria, and set forth the procedures and tests that will be used to demonstrate that the process does what it is intended to do and results in an output that meets the predetermined acceptance criteria. Ideally, the protocol should be written by those most familiar with the process to be validated, with input from other organizational units as necessary and appropriate. Development, process engineering, production, and regulatory affairs departments should almost always be involved. Other departments that might have input are purchasing, warehousing, and compliance. The quality assurance department must be involved at all phases of protocol development and must approve the final protocol before validation begins.

Protocols fit two broad categories. Qualification protocols are used for process equipment, such as tanks, mills, piping systems, autoclaves, ion exchange units, chromatography columns, and stopper washers. Validation protocols are used for processes that employ the qualified equipment and for processes related to the equipment, such as cleaning and sterilization.

It is convenient to break down equipment qualification into several steps such as design, installation, and operational as described below for the coffee brewing example.

Tasting studies may have shown that customers preferred coffee produced by pouring hot water through ground coffee supported on a filter. The proportions of coffee and water as well as the coffee type and grind, filter type, the brewing time, and the temperature were known from the development studies used to support the tasting. Adequate design qualification used in equipment selection will ensure the commercial brewer and grinder will meet the process requirements established during development. Factors to be considered include materials of construction, ease of use, space requirements, utilities, and process interactions (e.g., compatibility, adsorption, and leachables), and cleaning and maintenance.

Once selected, the equipment is installed, ensuring that electrical and water supplies are available and adequate and that necessary operational and storage space for supplies is convenient and available. The shop must be set up and arranged to optimize workflow. Space and facilities for equipment cleaning must also be available. Processing settings and conditions must be checked and calibration of water temperature, flow rate controls, and timers must be accomplished and documented. Cleaning procedures must be performed and evaluated for effectiveness and any problems corrected.

The installed and qualified equipment may then be used in start-up and training exercises to ensure everything, including coffee shop staff, is ready for a successful opening day.

Validation of the coffee brewing process may take place during the operational phase of equipment qualification, although the validation studies extend backward and forward in time. Earlier activities include vendor qualification of the coffee supplier and roaster, qualification and validation of the water supply system, validation of the equipment cleaning processes, and any calibration programs and maintenance procedures. Later activities include periodic evaluations to ensure the brewing process is functioning as intended, evaluation of cleaning and maintenance procedures to ensure adequate frequency and effectiveness, and a review to determine whether any operational issues or employee training programs need to be adjusted.
This good-tasting coffee example is intended to stimulate thinking about the important points to consider when developing and marketing a product that consistently meets customer expectations. Although the product in question, good-tasting coffee, is not a biopharmaceutical, the same validation principles apply. The validated process must be robust, consistent, and do what it is intended to do.

Part 3 of this series will discuss validation of a non-traditional biopharmaceutical process, lifecycle, and change management and offers a summarization of the benefits of well-conceived and executed process validation studies.

Reference

1. R. Madsen, BioPharm International 31 (4) 26-30 (April 2018).

Article Details

BioPharm International
Vol. 31, No. 5
May 2018
Pages: 36-39

Citation

When referring to this article, please cite it as R. Madsen, “Understanding Validation and Technical Transfer, Part 2” BioPharm International  31 (5) 2018.

 

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Applied Statistics for FDA Process Validation (Philadelphia, PA, United States – May 17th-18th, 2018) – ResearchAndMarkets.com | Business

DUBLIN–(BUSINESS WIRE)–Apr 26, 2018–The “Applied Statistics for FDA Process Validation” conference has been added to ResearchAndMarkets.com’s offering.

Course “Applied Statistics for FDA Process Validation” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

Who Will Benefit:

This seminar is designed for pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control.Process Scientist/EngineerDesign EngineerProduct Development EngineerRegulatory/Compliance ProfessionalDesign Controls EngineerSix Sigma Green BeltSix Sigma Black BeltContinuous Improvement Manager

For more information about this conference visit https://ift.tt/2r2Q90S

View source version on businesswire.com:https://ift.tt/2HzEtsL

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Pharmaceutical Manufacturing

KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 04/26/2018 06:21 PM/DISC: 04/26/2018 06:21 PM

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Copyright Business Wire 2018.

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Cambrex hiring 12 new analytical scientists post $3.2m expansion

LSNE Announces Acquisition Of PSC Biotech’s Parenteral Manufacturing Facility – News Press Release

LSNE Announces Acquisition Of PSC Biotech’s Parenteral Manufacturing Facility

Lyophilization Services of New England
Posted on: 26 Apr 18

BEDFORD, N.H., April 24, 2018 /PRNewswire/ — Lyophilization Services of New England (LSNE), a leading contract development and manufacturing organization (CDMO), today announced that it has acquired PSC Biotech’s cGMP aseptic fill finish manufacturing facility located in Madison, Wisconsin.   This acquisition allows LSNE to expand its manufacturing capabilities, add new service offerings and accommodate its customers’ project timing requirements.   The new facility will be called LSNE-Madison.  Financial terms of the transaction were not disclosed.

LSNE-Madison is a 37,000 square foot multi-product facility that will be used for the manufacturing of final drug products for pre-clinical to Phase III/commercial use.  The facility currently includes a high speed, automated aseptic fill line and a 144-square foot lyophilizer with existing space for additional equipment and the ability to expand to over 100,000 square feet of production space over time. 

The facility will complement LSNE’s existing full-service parenteral manufacturing capabilities, which include vial filling, lyophilization, process development, QC analytical, secondary packaging, stability studies and regulatory support for clinical and commercial products at its three other FDA-inspected manufacturing sites.  This new facility will also increase LSNE’s capabilities to include the terminal sterilization of final product and additional quality control services. 

“This acquisition is a key part of our strategic growth plan to increase our operations and capacity and better serve our customers,” said Matthew Halvorsen, Chief Executive Officer at LSNE.  “We have experienced strong growth and increased demand over the last few years, and as the market continues to expand, we know it is imperative to be able to offer increased scheduling flexibility to existing and new clients. With the support of the Permira Funds, we are increasing our capacity to provide our clients with additional manufacturing redundancy backed by the outstanding level of service that LSNE is known for.”   

“With this acquisition, we are gaining strong talent that complements LSNE’s experienced and successful teams,” says Shawn Cain, Chief Operation Officer at LSNE.  “We look forward to working with the staff to build LSNE-Madison into a world class aseptic fill/finish facility focused on the manufacturing of lyophilized and liquid drug products. “

LSNE anticipates full manufacturing activities to commence later this year, following a short period of renovation and validation of the facility.  Additional information regarding the acquisition and capabilities will be available on LSNE’s website.

About LSNE

LSNE is a privately held company with four GMP facilities – three located in New England and one in Madison, WI.  LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including cycle development, cGMP fill finish, and lyophilization.  Through the thoughtful integration of four processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.

About PSC Biotech

PSC Biotech is global life sciences technology company serving customers in North America, Europe, Asia, South America and the Middle East.  PSC Biotech provides professional technical services such as commissioning, qualification, validation project management, regulatory affairs, quality, compliance, conceptual engineering, Information Technology, metrology services, computerized system validation, etc., to life science, pharmaceutical and software companies.  It also provides world class enterprise quality management software solutions – Adaptive Compliance Engine™ (ACE) and AuditUtopia™.

Media Contact

Christine Palus

Vice President of Sales & Marketing

(603) 668-5763

info@lyophilization.com

www.lyophilization.com

Editor’s Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 26/04/2018

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Thursday, April 26, 2018

Pharmaceutical Glass Ampoules Market Manufacturers, Data Validation, Scope, Drivers and Forecast 2023 – Healthcare News

Pharmaceutical Glass Ampoules Market Report 2018 provide emerging opportunities in the Industry and its growth prospects over the coming years. Report includes the Pharmaceutical Glass Ampoules industry company profile, Main Business Information, SWOT Analysis, Sales, Revenue, Price and Gross Margin, and market shares for each company as well as Pharmaceutical Glass Ampoules Market report also contains Consumption, Sales, production value, cost/profit, supply/demand, import/export, Analysis of Industry Chain Structure, Economic Impact, Market Dynamics, and Proposals for New Project is also added.

Pharmaceutical Glass Ampoules Market report covers data on regional markets including CAGR of XX% from 2018 to 2023., historical and future trends for supply, market size, prices, trading, competition and value chain as well as major vendor’s information.

Ask PDF Sample for More Details of Pharmaceutical Glass Ampoules Market Report at https://ift.tt/2HQOwNn

Pharmaceutical Glass Ampoules Market Competitor Segment: The report includes global key players as well as some small players. The Information of Pharmaceutical Glass Ampoules Market for Each Competitor Includes:

  • Company Profile
  • Main Business Information
  • SWOT Analysis
  • Sales, Revenue, Price and Gross Margin
  • Market Share

View More Details of Pharmaceutical Glass Ampoules Market Report at https://ift.tt/2vP41QT

Pharmaceutical Glass Ampoules Market Geography Segment, Regional Supply, Application-Wise and Type-Wise Demand, Major Players, Price Is Presented from 2013 To 2023. This Report Covers Following Regions:

  • North America
  • South America
  • Asia & Pacific
  • Europe
  • MEA (the Middle East and Africa)

The key countries in each region are taken into consideration as well, such as United States, China, Japan, India, Korea, ASEAN, Germany, France, UK, Italy, Spain, CIS, and Brazil etc.

There Are 11 Chapters to Deeply Display the Pharmaceutical Glass Ampoules Market, 2023 Research Report.

Firstly, the report provides a basic overview of the industry including its definition, applications and manufacturing technology. Then, the report explores the international and major Pharmaceutical Glass Ampoules Market players in detail.

Price of Report: $ 4000 (Single User Licence)

Purchase at https://ift.tt/2HUSLr4

In this part, the report presents the Research Scope, Methodology, Data Collection, Data Analysis and Research Sources of Pharmaceutical Glass Ampoules Market.

Through the statistical analysis, the report depicts the global total market of Pharmaceutical Glass Ampoules Market including Market Landscape, Trend Analysis (Drivers, Restraints, Opportunities, and Threats), Industry Chain Analysis, Latest Market Dynamics and Trading Analysis of Pharmaceutical Glass Ampoules Market.

Through the Historical and Current Pharmaceutical Glass Ampoules Market in the region, the report depicts the global total market of Pharmaceutical Glass Ampoules Market including Supply, Demand by End Use, Competition by Players/Suppliers, Type Segmentation and Price and Key Countries Analysis

The total market is further divided by company, by country, and by application/type for the competitive landscape analysis. The report then estimates 2018-2023 market development trends of Pharmaceutical Glass Ampoules Market.

 

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Antibe Therapeutics Announces CEO Letter to Shareholders


Antibe Therapeutics Inc. (TSXV: ATE, OTCQB: ATBPF):


To our stakeholders,


The recent success of our lead drug, ATB-346, in its Phase 2B
gastrointestinal (“GI”) safety clinical study was a significant
milestone for Antibe and represented a major inflection point in our
value. Furthermore, we are now one clinical study away from the
strategic monetization of our drug platform for the major markets. With
such an important and exciting time ahead of us, we thought this would
be an ideal opportunity to communicate our strategy for the next year
and beyond.


Nearly ten years ago, Antibe was formed to develop safer medicines for
pain and inflammation by leveraging our novel hydrogen sulfide (“H2S”)
technology. Over this period, our strategy to maximize value for
shareholders has remained consistent: advance our drug candidates to
Phase 2 proof-of-concept data and secure high-value partnerships for the
large pharmaceutical markets. Fast forward to 2018: we now have
unequivocal validation of our H2S platform, and are
well-positioned to conclude a series of transformational partnerships
over the next 12-18 months.


This progress could not have been done without the support of our
shareholders, who are now being rewarded for their patience over the
years. In the months ahead, our team will be working diligently to
ensure that our clinical and business development activities are well
aligned with our strategy to maximize shareholder return.


Recent Phase 2B Study Confirms Best-in-Class Status for Drug
Platform


In Antibe’s latest Phase 2B study, ATB-346 showed unequivocal
superiority to naproxen in GI safety (2.5% versus 42.1% ulceration rate)
in 244 healthy volunteers. This human proof-of-concept data replicated
the results of our pre-clinical studies, and provides clear validation
of the GI-protective properties of our H2S technology. The
full analysis of this study will be reported this quarter. We are now
pushing forward with the planned Phase 2 effectiveness study for
ATB-346, and are accelerating development of our other H2S
platform drugs. Each of Antibe’s drugs has blockbuster potential, and
would provide physicians and consumers with radically safer alternatives
to today’s NSAIDs and to the multi-dimensional dangers of
corticosteroids and opiates.


Upcoming Phase 2 Effectiveness Study Designed to Validate Efficacy
of ATB-346


With human GI safety for ATB-346 now firmly established, our next
clinical objective is to validate its effectiveness at reducing pain in
osteoarthritis (“OA”) patients. In August 2016, Antibe released top-line
data from a Phase 2A study that showed considerable pain relief for
ATB-346 at a once-daily dose of 250 mg – the pain relief observed was
nearly double that of naproxen and Celebrex based on published data.
Although these results were encouraging, the study was conducted in a
small number of patients and was not controlled. Our upcoming Phase 2
effectiveness study is designed to validate the pain reduction efficacy
of ATB-346 (versus control) and will be conducted in approximately 250
OA patients. In addition, we have biomarker data derived from Phase 1
and Phase 2 blood assays that suggest ATB-346 is effective at lower
doses; for this reason, the study will include two additional dosing
cohorts with the goal of determining the lowest effective dose.
Preparations are well underway for this study and we anticipate
commencing it by July with a data read-out in Q4 2018.


Additional Clinical Activities to Support Global Partnering Efforts


In addition to the Phase 2 effectiveness study, Antibe will also be
strategically allocating R&D spend towards activities that we feel will
be of the most value to global partners. These activities include: (i)
long-range animal toxicology studies (6 months and 9 months) for
ATB-346, a standard regulatory requirement for approval of any drug;
(ii) additional metabolic studies for ATB-346 to further strengthen our
understanding of its pharmacokinetic profile; and (iii) the completion
of IND-enabling studies for both ATB-352 and ATB-340, Antibe’s two other
H2S platform drugs. Although ATB-352 and ATB-340 are earlier
stage, both individually represent blockbuster drug opportunities and
have been considerably de-risked by the latest validation of our H2S
technology. We remain particularly excited about the potential of
ATB-352, a non-addictive, potent analgesic for acute pain that directly
addresses the global opioid epidemic, a crisis that the world is
struggling to contain.


Partnering Discussions Building Momentum


In the past, Antibe’s partnering efforts were focused on strategically
out-licensing the rights for smaller markets (i.e., outside of the
United States and Western Europe). We continue to have these discussions
and have been successful in concluding two regional deals to-date – this
activity remains valuable as it provides non-dilutive funding and
further validation of our drug platform. The recent human
proof-of-concept GI safety data have undoubtedly benefited these
on-going discussions, and more importantly, now allow us to engage
multinational pharmaceutical firms to secure strategic partnerships for
the large markets. As mentioned earlier, our clinical development
activities in the next 12 months are designed to maximize the value of
our drug platform and strengthen our position as we engage potential
partners.


Commercial Asset in Regenerative Medicine Well-Positioned For
Growth


Our subsidiary, Citagenix Inc. (“Citagenix”), is nearly done assembling
the building blocks for its growth strategy in the dental regenerative
medicine market. Citagenix’s sales team in the United States is working
hard at expanding its distribution network, and recently signed Benco
Dental, the 3rd largest dental distributor in the US by
market share. Antibe’s relationship with Citagenix has been a symbiotic
one: Antibe provided the resources to position Citagenix on a growth
trajectory while Citagenix provided valuable diversification. With
Citagenix now on a path to growth and Antibe’s drug development
activities de-risked considerably by the recent GI safety data, our team
will now begin exploring strategic alternatives for Citagenix in an
effort to unlock value for shareholders.


Strong Balance Sheet and Maturing Capital Markets Strategy


Antibe’s balance sheet is well-funded with approximately $5 million of
cash, and recently benefited from the entire conversion of its
debentures. The upcoming Phase 2 effectiveness trial for ATB-346 will be
funded entirely with cash-on-hand. In addition, given our stage of
development, we are now exploring a listing on the NASDAQ exchange to
grow our institutional investor base in the United States.


We look forward to the year ahead as we drive closer towards our goal of
bringing safer medicines to market for pain and inflammation.


Sincerely,


Dan Legault
Chief Executive Officer


About Antibe Therapeutics Inc.


Antibe develops safer medicines for pain and inflammation. Antibe’s
technology involves linking a hydrogen sulfide-releasing molecule to an
existing drug to produce a patented, improved medicine. Antibe’s lead
drug ATB-346 targets the global need for a safer, non-addictive drug for
chronic pain and inflammation. ATB-352, the second drug in Antibe’s
pipeline, targets the urgent global need for a non-addictive analgesic
for treating severe acute pain, while ATB-340 is a GI-safe derivative of
aspirin. https://ift.tt/2BWXRQt;


Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the
sales and marketing of tissue regenerative products servicing the
orthopedic and dental marketplaces. Since its inception in 1997,
Citagenix has become an important source of knowledge and experience for
bone regeneration in the Canadian medical device industry. Citagenix is
active in 15 countries, operating in Canada through its direct sales
teams, and internationally via a network of distributor partnerships. www.citagenix.com.


Forward Looking Information


This news release includes certain forward-looking statements, which may
include, but are not limited to, the proposed licensing and development
of drugs and medical devices. Any statements contained herein that are
not statements of historical facts may be deemed to be forward-looking,
including those identified by the expressions “will”, “anticipate”,
“believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar
expressions. Forward-looking statements involve known and unknown risks
and uncertainties that could cause actual results, performance, or
achievements to differ materially from those expressed or implied in
this news release. Factors that could cause actual results to differ
materially from those anticipated in this news release include, but are
not limited to, the Company’s inability to secure additional financing
and licensing arrangements on reasonable terms, or at all, its inability
to execute its business strategy and successfully compete in the market,
and risks associated with drug and medical device development generally.
Antibe Therapeutics Inc. assumes no obligation to update the
forward-looking statements or to update the reasons why actual results
could differ from those reflected in the forward-looking statements
except as required by applicable law.



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Full steam ahead for Dunkirk pharmaceutical plant

Data Integrity Code of Conduct

Data is the great enabler when it comes to manufacturing processes. But not all data is good. Industry pundits estimate that about 85 percent of the data generated in manufacturing has absolutely no value at all. Which makes one wonder if some of that useless information can cause problems.

What to do with all that data—the good and the bad— is not a new area of discussion, but it is still on the forefront of the minds of pharmaceutical executives, especially as they respond to Food & Drug Administration (FDA) enforcement actions. In recent years, there has been an increase in warning letters to companies around deviations from current good manufacturing practices (CGMP) in manufacturing facilities.

The number of drug GMP warning letters went from 42 in 2015 to 102 in 2016 to 114 in 2017. This puts more emphasis on data integrity in the industry.

The FDA uses the acronym ALCOA to define data integrity, meaning, it is attributable (who did it/source data), legible (recorded in a permanent medium and it is readable), contemporaneous (data recorded in real time), original (an original or certified true copy of data), and accurate (no errors or editing performed without documented amendments).

Addressing ALCOA took center stage during the recent Interphex conference in New York. A keynote presentation by Els Poff, executive director of the data integrity center of excellence at Merck, discussed details of data integrity from log-ins to definitions to validation and verification—as it relates to ALCOA. In addition, Poff, who is on the Parenteral Drug Association (PDA) data integrity task force, said the organization is working on a comprehensive set of tools for industry that includes a technical report, which will be available at the end of the year, that will address new requirement challenges related to Industry 4.0 and Big Data.

The PDA has already released the Elements of a Code of Conduct for Data Integrity, which addresses the culture of data integrity. It touches on actions that can contaminate data, like employee errors or system configuration problem with electronic data handling.

This code of conduct is important because, like cybersecurity, data integrity is everyone’s business. The document provides an in-depth guidance for life science companies with a focus around a handful of actions :

  • Applicability – The company should establish requirements and implement programs to provide employees with training on the fundamental principles of data integrity.
  • Data collection, analysis, reporting and retention – The company shall establish procedures, documentation and control systems to maintain data integrity by collecting, analyzing and reporting data on paper and in computer systems with the appropriate security, audit trails, validation and oversight of electronic documents.
  • Electronic access security measures – Any computer data acquisition system should have secure access to prevent unauthorized changes to electronic data.
  • Investigating wrongful acts – Procedures for investigating an alleged falsification shall include documented in-depth review, conducted in a fair and balanced manner by independent personnel.
  • Data integrity of outsourced services and purchased raw materials – as part of a vendor/supplier qualification program, the company will confirm that contractors, vendors or other third party providers have established policies, standards, procedures or other documents that adhere to data integrity requirements.

The PDA code of conduct boils down to having a common understanding of the expectations for employee and management behaviors. Moreover, the path to data integrity should be “complete, consistent and enduring,” Merck’s Poff noted in her keynote. “Do you have all of the data and meta data over the lifecycle? Do you have processes in place with data and time stamps? Is the data on media that is still retrievable?”

This is not rocket science. But we are living in the era of organization. And, many of these things can get overlooked. To get your pharma house in order, download the free PDA code of conduct document.

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Tuesday, April 24, 2018

2 Day Course: The A to Z’s of Microbial Control, Monitoring and Validation of Water Systems (San Francisco, CA – August 23-24, 2018) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “The
A to Z’s of Microbial Control, Monitoring and Validation of Water
Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and
Personal Care Products”
conference has been added to ResearchAndMarkets.com’s
offering.

This course is designed to provide a microbiology-focused education
about all aspects of water systems and how biofilm manages to thrive
there.

Prior microbiological education or training, though a plus, is not a
requirement, since this training is for everyone involved with water
systems, from the lab to utility room operations. The instructor will
provide the necessary background needed to understand this very
important subject matter.

This understanding is essential for the proper design, validation,
operation, monitoring, and maintenance of a high purity water system.
Without this understanding, water system control and monitoring consists
of a set of rules that often don’t work or result in erroneous
monitoring data and can cause everything from very costly and
unnecessary system downtime to patient injury and product recalls.

Agenda

Day 1 (8:30 AM – 4:30 PM)

  • Basics of Water System Biofilm Control by Design & Operation
  • Successful Water System Sanitization
  • Common Sense Water System Validation
  • Understanding and Controlling Endotoxin
  • Harmonizing vs. Optimizing Water Microbial Testing for System Quality
    Control

Day 2 (8:30 AM – 4:30 PM)

  • Microbial Enumeration Issues with High Purity Water Systems
  • Reducing Water Microbial Excursions & Improving Investigations
  • Water System Investigation “How-To’s” and Example Case Studies
  • Leadership in MFG Contamination Control: The Microbiology Lab
  • USP Chapter: What USP Says about PW, WFI, Pure Steam & Micro Issues
  • Guarding Against Common Pharmaceutical Water System Inspection Pitfalls

For more information about this conference visit https://ift.tt/2FdWvyu

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Tetra Bio-Pharma Signs Landmark Commercialization Term Sheet for its Lead Pharmaceutical Product, PPP001, in Israel

OTTAWA, ONTARIO–(Marketwired – April 24, 2018) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP) (OTCQB:TBPMF), announced today that the Company has signed a first binding term sheet for the marketing and distribution of PPP001 in Israel with Kamada Ltd., a leading pharmaceutical company. The signing of a Definitive Distribution Agreement is expected to follow shortly. PPP001 is being developed to be the first smokable cannabis product for advanced cancer pain available under prescription.

This first international market commercialization agreement represents a significant milestone and a validation of Tetra Bio-Pharma’s business model with a leading Israel-based pharmaceutical company. Israel, like Canada, is considered one of the world leaders in the production and development of cannabinoid-based products. Kamada is a company with two FDA-approved products and an Israeli-based distribution segment that has demonstrated continued growth. Tetra Bio-Pharma intends to work closely with Kamada as PPP001 advances towards regulatory approval and commercial launch in Israel.

Under the terms of the anticipated final agreement, Kamada will be responsible for registering the product, as well as all marketing and distribution, in Israel. Tetra will be eligible to receive certain milestone payments and an undisclosed percentage of the sales of PPP001 generated by Kamada in Israel.

About PPP001

On April 4, 2018, Tetra Bio-Pharma officially started the Phase 3 trial for PPP001 indicated for terminal stage cancer patients with a goal to improving the quality of life of these patients as well as minimizing their pain. PPP001 is being developed to be the first smokable cannabis product for advanced cancer pain available under prescription.

About Tetra Bio-Pharma: Tetra Bio-Pharma (TSX VENTURE:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products. Tetra Bio-Pharma is currently developing a pipeline of five cannabinoid-based products using different delivery systems such as smokable pellets, oral tablets, eye drops and topical ointments. More information at: www.tetrabiopharma.com

Source: Tetra Bio-Pharma

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

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LSNE Announces Acquisition Of PSC Biotech’s Parenteral Manufacturing Facility

LSNE-Madison is a 37,000 square foot multi-product facility that will be used for the manufacturing of final drug products for pre-clinical to Phase III/commercial use.  The facility currently includes a high speed, automated aseptic fill line and a 144-square foot lyophilizer with existing space for additional equipment and the ability to expand to over 100,000 square feet of production space over time. 

The facility will complement LSNE’s existing full-service parenteral manufacturing capabilities, which include vial filling, lyophilization, process development, QC analytical, secondary packaging, stability studies and regulatory support for clinical and commercial products at its three other FDA-inspected manufacturing sites.  This new facility will also increase LSNE’s capabilities to include the terminal sterilization of final product and additional quality control services. 

“This acquisition is a key part of our strategic growth plan to increase our operations and capacity and better serve our customers,” said Matthew Halvorsen, Chief Executive Officer at LSNE.  “We have experienced strong growth and increased demand over the last few years, and as the market continues to expand, we know it is imperative to be able to offer increased scheduling flexibility to existing and new clients. With the support of the Permira Funds, we are increasing our capacity to provide our clients with additional manufacturing redundancy backed by the outstanding level of service that LSNE is known for.”   

“With this acquisition, we are gaining strong talent that complements LSNE’s experienced and successful teams,” says Shawn Cain, Chief Operation Officer at LSNE.  “We look forward to working with the staff to build LSNE-Madison into a world class aseptic fill/finish facility focused on the manufacturing of lyophilized and liquid drug products. “

LSNE anticipates full manufacturing activities to commence later this year, following a short period of renovation and validation of the facility.  Additional information regarding the acquisition and capabilities will be available on LSNE’s website.

About LSNE

LSNE is a privately held company with four GMP facilities – three located in New England and one in Madison, WI.  LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including cycle development, cGMP fill finish, and lyophilization.  Through the thoughtful integration of four processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.

About PSC Biotech

PSC Biotech is global life sciences technology company serving customers in North America, Europe, Asia, South America and the Middle East.  PSC Biotech provides professional technical services such as commissioning, qualification, validation project management, regulatory affairs, quality, compliance, conceptual engineering, Information Technology, metrology services, computerized system validation, etc., to life science, pharmaceutical and software companies.  It also provides world class enterprise quality management software solutions – Adaptive Compliance Engine™ (ACE) and AuditUtopia™.

Media Contact
Christine Palus
Vice President of Sales & Marketing
(603) 668-5763
info@lyophilization.com
www.lyophilization.com

Cision View original content with multimedia:https://ift.tt/2FbEDV2

SOURCE Lyophilization Services of New England

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Monday, April 23, 2018

EU hits Indian drugmaker Theon Pharma with warning letter for falsifying records, other issues

Cambrex Completes New $3.2 Million Analytical Research & Development Laboratory at its High Point, NC Facility NYSE:CBM

EAST RUTHERFORD, N.J., April 23, 2018 (GLOBE NEWSWIRE) — Cambrex Corporation (NYSE:CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced that it has completed the construction and validation of a new $3.2 million, 11,000 sq.ft. analytical laboratory at its High Point, NC facility. The investment was driven by a growing customer demand for analytical development and validation services in support of clinical stage cGMP products.

The expansion required the sourcing, acquisition, installation and qualification of more than 20 new analytical instruments, including HPLCs, mass spectrometers and support equipment. Cambrex plans to hire 12 new analytical scientists as a result of the investment. The laboratory’s primary function is to broaden analytical support for customer projects being developed and manufactured at the High Point site, while forming part of a strategic plan to support Cambrex’s global analytical development and method validation needs.

“The addition of this new facility further expands our capabilities in method development and qualification and validation, to ensure successful project development in the short term, and allowing efficient technical transfer of projects to commercial scale in the future,” commented Brian Swierenga, VP, Operations and Site Director for Cambrex High Point. “This expansion is part of Cambrex’s on-going strategic plan to increase development capacity and resources in North America.”

Cambrex acquired the 35,000 sq. ft. High Point site, formerly PharmaCore, Inc., in October 2016. At the facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100kg to support clinical trials from Phase I to Phase III. The site is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. The acquisition enhanced Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the US and Europe.

This latest expansion at the facility brings the investment at the site to over $5 million since the acquisition by Cambrex, and follows the announcement in May 2017 of an increase in pilot scale manufacturing capacity at the site.

About Cambrex

Cambrex Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics. The Company offers Active Pharmaceutical Ingredients (APIs), advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances and continuous processing. For more information, please visit www.cambrex.com

Contact:
Alex Maw                                                                               
Director, Marketing and Communications
Tel: +44 7803 443 155
Email: alex.maw@cambrex.com

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Company focus: Exscientia – PharmaTimes Magazine May 2018

With several high-profile collaborations under its belt, Exscientia is bringing AI tech straight to the heart of pharma R&D. We asked the company’s founder, Professor Andrew Hopkins, to explain how they’re hoping to make long, expensive drug development a thing of the past


What is your background?

I am the founder and CEO of Exscientia Ltd – the first company to automate drug design from idea to clinical candidate, using AI. Following a chemistry degree (Manchester) and a DPhil from Oxford, I spent ten years at Pfizer, where I was responsible for establishing new research foci including the concepts of druggability and network pharmacology. Subsequently, I went back into academia to develop these concepts and was one of the youngest professors when I was appointed as Chair of Medicinal Informatics at the University of Dundee. I have raised around £50 million for commercial and academic research activities in my role at the University. I founded Exscientia in 2012 as a spin-out from the University of Dundee. I am the author  of some of the most highly cited papers in modern  drug discovery.

What is the history of the company? What is the main drive behind the business?

The company is focused on dramatically improving productivity in the stage from initial chemical design to clinical candidate. This is the single most expensive part of drug development per launched drug; due to a perfect storm of high costs for each project (typically around $20 million), and even higher project attrition rates (the number of projects needed in reality to yield one marketed drug).

Exscientia’s goal is, starting from a project definition, to design and advance novel high-quality compounds (with excellent therapeutic properties) to clinical entry in one and a half years. It does this by applying AI to dramatically reduce the number of compounds required for analysis from typically 2,500 per project using traditional approaches, to just 500 when using AI-driven techniques.

Our approach is to fuse the power of AI with the discovery experience of seasoned drug hunters (key among which is Andy Bell, co-inventor of Viagra and other key molecules during his career). As a result, the company believes it is the first to automate drug design in a manner surpassing conventional approaches.

Since its establishment in 2012, Exscientia has achieved a series of collaborations, including more recently with Sanofi and GSK, which have helped to fuel expansion. Recently, Exscientia also opened a new  office in Oxford.

Tell us about your technology. How does it work? What is the history of the idea?

I recognised that there was a breadth of data in journals and patents which exceeded that available to any individual group or company. I also recognised that if organised appropriately, it should be possible to make connections in a way that was more systematic and strategic.

Many members of Exscientia worked on some of the first IT systems to curate data from multiple sources (such as SAR data from patents and literature) and applied it productively to drug discovery. The next crucial step was to develop an automated drug design system that could combine these data with a mass of other inputs, such as internal HTS screens, fragment screens, protein structure data, and other information – in order to efficiently design novel, patentable chemical entities for synthesis and assay. Together with a young and talented academic group, a new approach to drug design was developed and published in Nature in 2012. Over time, we have enhanced and refined this AI-driven approach, testing it in partnership with pharmaceutical partners on real projects, which also helped fund our advancement without the need for external investment.

In these early partnerships, Exscientia has successfully and reproducibly completed projects to drug candidate stage within its target of 500 compounds and 12 months. For one partner, a candidate molecule was delivered within 12 months of project initiation. A key aspect of this speed is a tightly integrated Design-Make-Test cycle; here  the strategic selection of which compounds to make and test based on all data, coupled with rapid experimental turnaround (ideally two weeks), yields a rapid cycle of learning for each project undertaken.

The attractions of Exscientia’s approach and capabilities have resulted in several recent drug discovery collaborations with GSK, Sanofi, and Evotec, as well as a €15 million direct investment from Evotec, which becomes the company’s first external investor.

Can you give some specific examples of how you have collaborated with pharma companies?

In detail these collaborations are:

  • GSK (announced July 2017) – to discover novel and selective small molecules for up to ten disease-related targets nominated by GSK across multiple therapeutic areas (near-term milestone potential of £33 million)
  • Sanofi (April 2017) – up to €250 million strategic research collaboration and licence option agreement for bispecific small molecules targeting metabolic diseases (including diabetes and obesity)
  • Evotec (April 2016) – 50:50 co-development agreement to discover and develop small molecules focused on immuno-oncology. In September 2017, Evotec made a €15 million strategic investment in Exscientia becoming our first external investor.

How would you like to further develop the technology/business in the future?

A goal for the business is to routinely achieve the transformational productivity improvements we believe our AI-based approach can deliver, to build our own pipeline of novel drug compounds and to support our partners’ discovery efforts.

Being a participant in Elsevier’s Hive initiative will enable Exscientia to access Elsevier’s suite of information solutions and boost our existing capabilities. For instance, the Hive provides us with additional access to structured chemistry and activity data, ensuring that we have a comprehensive overview of what has been published already to support our ongoing projects. Similarly, the pathway and literature tools support our target identification and validation activities, and we look forward to partnering with Elsevier’s newest exciting initiatives around large-scale knowledge graphs.

AI is seeing huge amounts of interest from pharma at the moment. Do you think the potential matches the hype?

AI, if used correctly, has the potential to transform the productivity of drug discovery and deliver superior candidates into the clinic. This will change the way discovery is done. We are extremely encouraged by the results we have seen with our own programmes and the progress of molecules through the development process will provide validation of the benefits of an AI-based approach. The challenge is how to develop applications that apply AI productively, rather than questions about AI itself.

What can the industry do to ensure that the use of AI technologies such as yours is as successful as it can be?

To be successful, big pharma must invest in big pharma. Large companies need to look critically at their incumbent processes and the associated metrics and ask whether those are the right processes to take them towards the future of drug discovery. We believe that our collaborators are already thinking along these lines and this will help advance  the technology.

What are the biggest challenges companies working in AI are facing at the moment? How are you aiming to tackle them?

Delivery is everything. The technologies are becoming more sophisticated as humans learn how best to apply the tech, and how best to work with the tech. However, it is not AI alone that can solve all these problems. We believe that the combination of a human with AI as a ‘Centaur’ team, will be better than either human process or AI process alone. This has already been shown in other areas, such as chess, where a human with a computer algorithm can typically beat both a human or a computer, when alone. Drug discovery is far more complex than a game of chess – for this reason we think of our chemists as ‘Centaur chemists’, allowing the AI to perform the design work whilst the chemist sets the strategy.

There will need to be an overhaul in how big pharma rethinks its strategy when it comes to the use of AI. This is why we believe we have such a strong advantage.

What are some of the greatest opportunities for AI pharma companies in the UK at the moment?

Drug discovery is the last artisan industry. One of the key opportunities is also its challenge; the amount of data now available is beyond any human’s capability to hold in its mind at one time. The use of AI for drug design, where Exscientia concentrates its expertise, will have unprecedented opportunity.

Other companies are looking at patient stratification and personalised medicine. For example, in patient stratification for clinical trials, AI may be used to fit the patient to the.

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Eurotas Expands its Customer Portfolio for WIT

BASEL, Switzerland, April 23, 2018 /PRNewswire/ —

Eurotas Inc., an industry pioneer and a leading consulting company specialized in Trackwise™, today announced that it has broadened its customer portfolio with another major global Pharma company, purchasing Eurotas’ best seller modules from the WIT product, the OFC, LUC and the ACE.

     (Logo: https://ift.tt/2F9aoOs )

Those modules will enable all Trackwise™ users and admins to perform and execute daily activities in an enhanced manner than they are able to today.

The OFC added the ability to perform instant complicated batch calculation on the form of deviations / Non-Conformity records. The LUC will be used mainly for the upcoming new sites rollouts that are planned in the next months in which large amount of login accounts needs to be created in a short period. Lastly, the ACE will provide instant CS (SDS) generation to enable all validation activities and compare instantly the configuration as part of the IQ execution.

Over the last 2 years, since the WIT was released, Eurotas’ WIT has had tremendous success as numerous pharmaceutical companies have purchased the WIT as a Trackwise™ add-on product to enhance their Trackwise™ with abilities that are not part of today’s Trackwise™. With this, Eurotas has had strong growth since the initial release till date, specifically with today’s announcement on the new purchase by a top pharma company, which will contribute to the WIT implementations strong pipeline for 2018.

“We are very pleased with the acceptance of the WIT by the pharma industry and this recent product sale is aligned with our growth strategy for the coming years,” said Yoni Halimi, Eurotas’ Co-Founder.

“We wanted to add value to all companies that choose Trackwise™ as their quality management system (QMS) software, by offering the WIT with its current 9 modules that are designed to increase the use and the flexibility of Trackwise™. We look to enhance Trackwise™ with our WS based tool, the WIT, which is a simple, fully configurable, state of the art software and most important a validated tool.”

WIT offers different modules, which allow end-users and admins to conduct better their daily activities that are circulating Trackwise™. More information is available at www.use-wit.com.

About the OFC

OFC provides users with one of the most required functions in TrackWise™, the ability to perform instant on form calculations. OFC is a predefined and configurable Web Service that is able to perform advanced math formulas. The module also offers the option to perform calculations according to defined selected selection values and to show the result as per the company’s internal calculation logic.

More information is available at https://ift.tt/2HSkQwR.

About the LUC

LUC module provides an automated way to create login accounts in mass numbers, including changes/updates to exiting login accounts with multiple user roles. LUC allows in one-step to create persons and to create login accounts for those persons, taking into considerations all the attributes for those login accounts.

More information is available at https://ift.tt/2HkAZtQ.

About the ACE

The ACE tool generates in a single click an up to date SDS/CS, with the entire system configuration in Excel format, which allows a quick and instant SDS/CS sign off. Not only that, this document is formatted and aligned in a way that allows administrators to find in a blink of an eye a specific configuration property across several configuration features. The ACE has proved to reduce significantly the validation efforts and increase its quality.

More information is available at https://ift.tt/2HUPfuu.

About Eurotas

Eurotas is a consulting company that specializes in providing complete solution to all aspects of EQMS (Enterprise Quality Management Software) implementations and administration as well as on demand services to other EQMS systems.

Eurotas is an innovative and fast growing life science consultancy based on experts’ knowledge and experience and specializes in the following disciplines: Quality Management (QA), Technical Services, Validation, Compliance, Project Management and Quality Assurance activities.

For more information visit euro-tas.eu  or email us at contact@euro-tas.eu

SOURCE Eurotas

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Saturday, April 21, 2018

Big pharmaceutical players boost credibility in the Canadian cannabis industry | Finance

Canada’s largest retail pharmacy chain, Shoppers Drug Mart continues to lend possibly the most important voice of credibility to the emerging legal cannabis market-so far, having signed supplier deals with three of Canada’s largest cannabis growers, and leaving the door open for more to come.

With over 1,250 stores across Canada, the chain owned by Loblaw Companies Limited is a national retail heavyweight. So when Shoppers Drug Mart signed its latest supply deal with cannabis giant Aurora Cannabis, it marked the fourth supplier deal the retailer has inked, and the third with a Canadian major.

Two of the other companies that have already inked agreements with the retailer were Aphria Inc., and MedReleaf Corp., late last year. The retail vote of confidence for the emerging cannabis sector started early-Parent company Loblaw Companies Ltd. applied in October 2016 for a license to dispense medical marijuana.

See also:

Other pharmacies such as Lovell Drugs and PharmaChoice have already signed deals with other cannabis suppliers; However, it’s the intensity of the spotlight that Shoppers Drug Mart casts that lends to speculation of which company will be the next to garner the retailer’s favorable access to mainstream consumers. One potential new cannabis supplier for Shoppers Drug Mart could be up-and-comer MYM Nutraceuticals, which is in line to have Canada’s largest cannabis greenhouse facility in Weedon, Quebec, and is partnered on Australia’s largest in New South Wales.

How many suppliers that Shoppers Drug Mart will carry is still yet to be determined. Should an MYM Nutraceuticals or another outfit join the ranks of Aphria Inc. and now Aurora Cannabis, it would be yet another significant stamp of approval given by a leading retailer in the leadup to legalization.

Shoppers like big growers

The addition of Aurora Cannabis to the Shoppers Drug Mart portfolio was another signal that bigger is better to the retailer. Primary to the deal is the expectation that Aurora’s products will be sold online, according to the press release. 

“The Shoppers and Aurora brands are trusted to deliver high-quality products and excellent customer service,” said Terry Booth, CEO of Aurora Cannabis. “Partnering with Shoppers Drug Mart, Canada’s largest pharmacy retailer, is yet another validation of the scale and maturity of our company, and of the demand for Aurora’s medical cannabis. With its massive facility located adjacent to the Edmonton International Airport, Aurora is one of the largest producers in the country operating today.”

Not to be outdone, fellow Shoppers Drug Mart supplier, MedReleaf recently announced the purchase of 164-acre property in Exeter, Ontario, which includes 1 million square feet of existing greenhouse. The property adds 105,000 kilograms of cannabis production capacity annually to MedReleaf’s balance sheet.

However, it’s the upcoming 1.5 million square feet of growing space planned by MYM Nutraceuticals in Weedon, Quebec that stands to be the largest project in the country once completed. Once coupled with the company’s primary facility in Laval, Quebec, and with its international ventures in Australia, and Colombia, MYM should have a line of suitors that could very well include Shoppers Drug Mart in the coming months.

MYM’s massive footprints

In the lead-up to construction on its massive 1.5 million square-foot facility at Weedon, MYM Nutraceuticals received a boost of confidence and cash from a recent $10,000,000 financing that will move the company closer to its goals in 2018.

“All of us at MYM are very excited about the future of our company,” said Rob Gietl, CEO of MYM in the accompanying press release. “This excitement extends to our family and friends who have participated in this non-brokered financing. We have many major milestones to achieve this year that will shape MYM for years to come. Continued global expansion and leveraging the relationships we have built, will ensure that MYM and its shareholders have a bright future.”

The net proceeds are intended to be used towards general working capital and corporate purposes as the company pursues development on its two Quebec production projects, and its partnered 1.2 million square foot production facility dubbed the Northern Rivers Project in New South Wales, Australia.

At the Weedon, Quebec project, MYM currently owns 75% (which goes up to 90% upon completion), and is set to help the municipality become the official cannabis capital of Canada. While there are other mega-greenhouse projects in other provinces in Canada, MYM’s decision to house their operations in Quebec was very strategic- From an economic perspective, it can’t be ignored how cheap Quebec’s costs are.

Quebec labor costs on average 34% less than in the US, and 16% less than in G7 countries. Electricity is 36% cheaper than in the US, and 49% lower, on average, than in the G7 countries. Quebec’s taxes on investment are the lowest in Canada, and more importantly lower than the average of the US, G7 countries, and the OECD countries. The province offers an investment tax credit that covers up to 24% of the cost of newly purchased manufacturing and processing equipment and reimburses sales tax on capital goods.

Once MYM’s Weedon location is opened, there’s a possibility that it can provide MYM with a quantity-, and location-based cost advantage that could benefit them to the point of making a deal with a retail giant such as Shoppers Drug Mart. With cash in hand, and a steady momentum, it could be a good year for MYM Nutraceuticals.



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KL1333 receives FDA ODD for mitochondrial diseases

NeuroVive Pharmaceutical AB has been granted Orphan Drug Designation for its project KL1333 for treatment of inherited mitochondrial respiratory chain diseases…

KL1333

NeuroVive Pharmaceutical AB the mitochondrial medicine company, has announced that it has been granted Orphan Drug Designation by the United States FDA Office of Orphan Products Development for its project KL1333 for treatment of inherited mitochondrial respiratory chain diseases (MRCD).

Orphan drug designation (ODD) will give the KL1333 program extra access to regulatory and scientific advice and interactions at the FDA and may enable a focused development program and speedy approval process. ODD opens up for market exclusivity for seven years within US for NeuroVive´s KL1333, when authorised for marketing.

“The ODD approval by the US FDA is a validation of the quality of the KL1333 documentation to date and yet an important milestone for NeuroVive and the KL1333 project. The ODD will be beneficial to us in our efforts to rapidly document the effects and safety of KL1333 in genetic mitochondrial diseases and bring this novel treatment opportunity to the market and patients who are in great need of it,” said Erik Kinnman, CEO, NeuroVive.

KL1333 has been developed by the South Korean pharmaceutical company Yungjin Pharm and has in pre-clinical models been shown to increase mitochondrial aerobic energy production, while limiting the accumulation of lactate, counteracting the formation of free radicals and lead to other long-term positive effects on energy metabolism such as the formation of new mitochondria.

NeuroVive was 2017 granted exclusive rights from Yungjin Pharm to develop and commercialise KL1333 globally, except in Korea and Japan where Yungjin Pharm retains its exclusive rights. The companies will develop KL1333 within their respective territories collaborating closely on an international level to utilise possibilities for synergies. The first clinical phase I study has recently recruited its last healthy volunteer and results are expected by June. NeuroVive plans to start the next clinical phase I multiple ascending dose study in the second half of 2018.          

In the EU, Orphan Drug Designation has been obtained for the treatment of the genetic mitochondrial disease: Mitochondrial Myopathy, Encephalopathy, Lactic acidosis and Stroke-like episodes (MELAS).

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Friday, April 20, 2018

Mitch Lewandowski Joins PCI Pharma Services as Executive Director of Quality

Mitch Lewandowski

Global pharmaceutical outsourcing services provider PCI Pharma Services is pleased to announce that Mitch Lewandowski has joined as the new Executive Director of Quality for its Rockford, IL site.

PCI’s Rockford location features seven facilities, with a broad range of services including commercial contract packaging, analytical laboratory services, clinical trial packaging and labeling, as well as clinical trial logistics for storage, distribution, and returns management. In addition, the site supports some light manufacturing activities including powder blending.

Mitch comes to PCI with a depth of experience and a proven track record, with more than two decades of experience in the healthcare industry. His previous employments include leading pharmaceutical, medical and healthcare companies such as Abbott Diagnostics, Beckman Coulter, St. Jude Medical Center, Exact Sciences and most recently Dohmen Life Sciences.

Mitch has an extensive background in investigation writing, regulatory inspection, validation, risk and data integrity assessment, procedure writing, audit execution, development of change management systems and CAPA. In addition, Mitch has worked in multiple laboratory environments, is certified in Quality Management and Operational Excellence (CQM/OE) and has earned a Lean/Six Sigma Black Belt.

“Mitch brings a diverse background in quality and truly understands the evolving global needs of our customers,” stated Jeannie Metzinger, PCI Vice President of Quality. “Quality and regulatory requirements are continually changing in our industry, particularly as the market continues to expand globally. We are very excited to have Mitch join the PCI team and make his own impact on the company’s commitment on providing the industry’s leading customer experience. Mitch’s demonstrated leadership has him well positioned to lead the Rockford team.”

The seven facilities at PCI’s Rockford location total over 1,000,000 square feet with services supporting pharmaceutical and biotech packaging, as well as medical device, animal health and consumer healthcare products. Founded in 1967, the site recently celebrated 50 years in pharmaceutical contract packaging services and had experienced significant growth and expansion, currently employing more than 1,800 associates. Continued investments by PCI have significantly expanded capacity, most recently with investments in cutting edge Serialization technologies as well as installations of new bottling and pouching lines.

In addition to his extensive professional experience, Mitch holds a Bachelor’s degree in Biochemistry from Boston University as well as a Master’s Degree in Public Health, Biostatistics and Epidemiology from the University of Minnesota. a Master’s Degree in Public Health, Biostatistics and Epidemiology from the University of Minnesota.

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Thursday, April 19, 2018

‘An Incredible Signal’: 4 Experts Weigh In On Positive FDA Panel Vote For GW Pharma (NASDAQ:GWPH)’s Epidiolex

Shares of GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) were halted Thursday, ahead of a Food and Drug Administration vote on the company’s cannabis-derived drug Epidiolex. Trading resumed after the FDA advisory panel voted unanimously in favor of approving the medicine for the treatment of two rare childhood-onset forms of epilepsy that are commonly treatment-resistant.

The vote is non-binding and a final decision is expected by June 27, but it is customary for the FDA to act on its advisors’ recommendations.

While the cannabis plant is used to produce Epidiolex, the medicine is derived from CBD, a non-psychoactive component found in marijuana that is legal in all 50 states and contains less than 0.1-percent THC — the psychoactive component in weed that makes users feel “high.”

GW Pharmaceuticals offered “substantial evidence” to back Epidiolex’s effectiveness, according to the FDA panel’s report. While the drug carries a risk of liver injury, the side effects can be managed fairly well, the report said. 

Related Link: Exclusive: MassRoots Files SEC Paperwork For Cannabis Industry-Focused Cryptocurrency

Shares of GW Pharmaceuticals did not surge much on the news, as the market had already anticipated a decision and traded on speculation, with the stock gaining more than 5.6 percent since Monday.

Experts: Panel Vote A Milestone Moment 

The committee’s recommendation of approval for Epidiolex for epilepsy treatment on Thursday is “another step closer to full FDA approval,” Debra Borchardt, CEO at cannabis-focused financial media outlet Green Market Report, told Benzinga.

“Once that happens, it makes it harder for Congress to continue to list cannabis as a Schedule I controlled substance. If the FDA makes it clear that a cannabis-based pharmaceutical drug has medicinal value, then Congress can no longer claim there is no medicinal quality for cannabis.”

The favorable comments serve as “fundamental evidence” of the cannabis plant’s medical efficacy — as well as the investment opportunity surrounding the research and development of similar pharmaceutical products, said Harrison Phillips, vice president at Viridian Capital Advisors. 

Vridian expects to see additional cannabis-cased drug candidates introduced by companies for a variety of indications, Phillips said. 

“Furthermore, the acknowledgement by the FDA of cannabis’ potential medical efficacy is likely to rekindle debates as to the proper classification of cannabis, and particularly cannabidiol (CBD), the main active ingredient in GW’s product, under the Controlled Substances Act.”

Aras Azadian, CEO at AviCanna, the first cannabinoid therapeutics company to be admitted into Johnson & Johnson (NYSE: JNJ) Innovation’s JLABS @ Toronto, also seemed to agree with fellow cannabis experts. 

“It’s an incredible signal and further validation of the future potential of cannabinoid based therapeutics,” Azadian said of the FDA panel vote.

“Having unanimous support [from] the FDA advisory board of evidence-based cannabidiol drugs further motivates and validates the models of companies such as AviCanna and its partners to pursue clinical development of [their] intellectual property,” Azadian said. 

Finally, Benzinga reached out to Matt Karnes, founder and managing partner at GreenWave Advisors.

“While the consensus view is that FDA approval will occur, the impact such a decision will have on current DEA scheduling remains in question,” Karnes said. “Regardless, an FDA approval coupled with other positive news flow — including word from the Trump administration that it will not interefere with state-regulated marijuana markets — reduces an element of risk associated with cannabis investing,” he said.

Picture by Javier Hasse.

Related Link: Why GW Pharma’s Epidiolex Results Could Shape The Future Of Cannabis-Based Therapeutics

© 2018 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.



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