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.

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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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FDA Publishes Q&A on GMPs for APIs

On April 19, 2018, FDA published a guidance document that answers questions about the implementation of the International Council for Harmonization (ICH) Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. ICH Q7 helps pharmaceutical companies ensure that APIs meet quality and purity characteristics. This Q&A document is in response to industry requests for clarification of some ICH Q7 sections.

Topics addressed in the Q&A document include quality management, personnel training, facilities, process equipment, documentation, materials management, production, storage, and validation. Specifically, the document clarifies requirements for releasing raw materials, sampling, product quality review, risk management, acceptance criteria, evaluation of material suppliers, and more.

Source: FDA

 

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Consultation, validation, training, and support

As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc., (ACC), specialises in bacterial endotoxin and
(1→3)-ß-D-glucan detection, using Food and Drug Association-licensed chromogenic, turbidimetric and gel-clot reagent technologies.

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Global Healthcare Analytical Testing Services Market 2018-2023 by Method Validation, Environmental Monitoring, Bioanalytical Services, Stability, Raw Materials, & Microbial Testing

DUBLIN, April 17, 2018 /PRNewswire/ —

The “Healthcare Analytical Testing Services Market by Type (Method Validation, Environmental Monitoring, Bioanalytical Services, Stability, Raw Materials, & Microbial Testing), End User (Pharmaceutical, Medical Device Companies) – Global Forecast to 2023” report has been added to ResearchAndMarkets.com’s offering.

The global healthcare analytical testing services market is projected to reach USD 5.97 Billion by 2023 from USD 3.43 Billion in 2018, at a CAGR of 11.7%.

The shift of focus towards analytical testing of biologics and biosimilars, increasing outsourcing of analytical testing by pharmaceutical companies, increasing acceptance of the QbD approach in pharma research/manufacturing, and adoption of FTE contracts in R&D outsourcing are the major factors driving the growth of the healthcare analytical testing services market.

The report analyzes the global healthcare analytical testing services market by type, end user, and region. On the basis of type, the bioanalytical testing segment accounted for the largest share of the global healthcare analytical testing servicess market in 2017. The large share of this segment is due to increasing number of drugs in the biopharmaceutical pipeline and the growing biopharmaceutical industry.

The global healthcare analytical testing services market by end user is segmented into pharmaceutical and biopharmaceutical companies, medical device companies and contract research organizations. In 2017, the pharmaceutical and biopharmaceutical companies segment accounted for the largest share of the market. The large share of this segment can be attributed to the increasing outsourcing of analytical testing services by pharmaceutical and biopharmaceutical companies to boost profit margins, avoid high capital expenditure, and reduce the time required to validate the process and product.

The rising demand for specialized analytical testing services and growth opportunities in emerging APAC countries are expected to provide further growth opportunities for players operating in the healthcare analytical testing services market. However, pricing pressure faced by market players and shortage of skilled professionals in the healthcare analytical testing services industry are some of the factors limiting the growth of this market during the forecast period.

Eurofins Scientific (Luxembourg) held the leading position in the global healthcare analytical testing services market in 2017. Over the past three years, the company has established itself as one of the leading players in the healthcare analytical testing services market.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights
4.1 Healthcare Analytical Testing Services Market Overview
4.2 APAC: Healthcare Analytical Testing Services Market, By End User & Country
4.3 Healthcare Analytical Testing Services Market: Geographical Snapshot
4.4 Healthcare Analytical Testing Services Market: Geographical Mix

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Focus on Analytical Testing of Biologics and Biosimilars
5.2.1.2 Increasing Preference for Outsourcing Analytical Testing
5.2.1.3 Rising Adoption of the Quality By Design Approach
5.2.1.4 Adoption of Fte Contracts in R&D Outsourcing
5.2.2 Restraints
5.2.2.1 Pricing Pressure Faced By Major Players
5.2.2.2 Shortage of Skilled Professionals
5.2.3 Opportunities
5.2.3.1 Rising Demand for Specialized Analytical Testing Services
5.2.3.2 Growth Opportunities in Emerging Asia Pacific Countries
5.2.4 Challenges
5.2.4.1 Innovative Formulations and Medical Devices Demanding A Unique Analytical Testing Approach
5.2.4.2 Development of Appropriate Dissolution Methods
5.2.4.3 Growing Need to Improve the Sensitivity of Analytical Methods

6 Industry Insights
6.1 Industry Trends
6.1.1 Growing Industry Consolidation
6.1.2 Long-Term Outsourcing and Preferred Vendor Partnerships
6.2 Regulatory Analysis

7 Healthcare Analytical Testing Services Market, By Type
7.1 Introduction
7.2 Bioanalytical Testing
7.2.1 Cell-Based Assays
7.2.2 Virology Testing
7.2.2.1 In Vitro Assays
7.2.2.2 In Vivo Assays
7.2.2.3 Species-Specific Viral Pcr Assays
7.2.3 Immunogenicity & Neutralizing Antibody Testing
7.2.4 Biomarker Testing
7.2.5 Pharmacokinetic Testing
7.3 Physical Characterization
7.3.1 Laser Particle Size Analysis
7.3.2 Thermal Analysis
7.3.3 Image Analysis
7.3.4 Surface Area Analysis
7.3.5 Other Physical Characterization Analysis Services
7.4 Method Development & Validation
7.4.1 Extractables & Leachables Method Development & Validation
7.4.2 Process Impurity Method Development & Validation
7.4.3 Stability Indicating Method Validation
7.4.4 Cleaning Validation Method Development
7.4.5 Analytical Standard Characterization
7.4.6 Technical Consulting
7.4.7 Other Method Validation Services
7.5 Raw Material Testing
7.5.1 Complete Compendial Testing
7.5.2 Heavy Metal Testing
7.5.3 Container Testing
7.5.4 Karl Fischer Analysis
7.5.5 Wet Chemistry Analysis
7.5.6 Other Raw Material Testing Services
7.6 Batch-Release Testing
7.6.1 Dissolution Testing
7.6.2 Elemental Impurity Testing
7.6.3 Disintegration Testing
7.6.4 Hardness Testing
7.6.5 Friability Testing
7.6.6 Other Batch-Release Testing Services
7.7 Stability Testing
7.7.1 Drug Substance Stability Testing
7.7.2 Formulation Evaluation Stability Testing
7.7.3 Accelerated Stability Testing
7.7.4 Photostability Testing
7.7.5 Comparative Stability Testing
7.7.6 Other Stability Testing Services
7.8 Microbial Testing
7.8.1 Microbial Limit Testing
7.8.2 Sterility Testing
7.8.3 Endotoxin Testing
7.8.4 Preservative Efficacy Testing
7.8.5 Water Testing
7.8.6 Other Microbial Testing Services
7.9 Environmental Monitoring
7.9.1 Air Testing
7.9.2 Wastewater/ETP Testing
7.9.3 Other Environmental Monitoring Services

8 Healthcare Analytical Testing Services Market, By End User
8.1 Introduction
8.2 Pharmaceutical & Biopharmaceutical Companies
8.3 Medical Device Companies
8.4 Contract Research Organizations

9 Healthcare Analytical Testing Services Market, By Region

10 Competitive Landscape
10.1 Overview
10.2 Market Share Analysis
10.3 Competitive Scenario
10.3.1 Acquisitions
10.3.2 Expansions
10.3.3 Partnerships, Agreements, and Collaborations
10.3.4 Services Launches

11 Company Profiles
11.1 Eurofins Scientific
11.2 Labcorp
11.3 SGS
11.4 Charles River
11.5 Wuxi Pharmatech
11.6 Pharmaceutical Product Development, LLC (PPD)
11.7 Exova
11.8 Pace Analytical
11.9 Envigo
11.10 Intertek
11.11 MPI Research
11.12 Merck KGaA
11.13 Source Bioscience

For more information about this report visit https://ift.tt/2EVq4EW

Media Contact:

Research and Markets
Laura Wood, Senior Manager
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Solving the Problem or Merely Addressing the Issue?

 

Photo Credit: CoreDESIGN/Shuttestock.comIncognito focuses on a big challenge in regulated analytical chemistry laboratories.


To put the title another way—why suture the wound when you can stop the bleeding with a tourniquet?

Well that works fine until the tourniquet is removed!

I have so many conversations about separation issues that end up with the other person glazing over when I start to explore the actual cause of the problem, which is typically something to do with chemistry.

Frankly, so many of us are just interested in finding a fix for the problem we have right now, to get the results out of the door, and who cares if the method is flawed; I just need the results for this batch (and who cares about the poor sap who has to run this method the next time—because I’m going to avoid it like the plague).

With problematic chromatographic methods such as these, just releasing the batches where the quality controls (QCs) manage to squeeze through the acceptance criteria and repeating system suitability tests until they fall within the specification is not the answer. I’m aware that companies are tightening up on repeated system suitability testing and initiating investigations where out of specification (OOS) results are caused by poor repeatability (agreement) of QC samples, but show me a laboratory where methods don’t have to be “tuned” or “equilibrated” or “system flushes” inserted to get them to work, and I’ll show you a rare laboratory indeed. Further, “investigations”, “root cause analysis”, and “CAPA (corrective and preventative action)” analysis are fine—if you actually know something of the root causes, the fundamentals, and the first principles on which the techniques operate.

So many laboratory staff are chromatography users rather than chromatographers these days (1) and I wonder how many are able to identify the root cause of the problem in the chemistry of the separation, the susceptibility of the column chemistry, the poor design of the eluent system, the bad injection solvent, and the nonrobust nature of the eluent pH selected? How many of your recent investigations actually identified the root cause and implemented a truly preventative measure? I would suggest that where problems with the separation are concerned, if no chemistry is involved in the investigation, then the root cause probably hasn’t been addressed.

When I ask the glazed correspondent what the chemistry of the analyte is, the majority state that they have no idea. Therefore, they probably have little chance of really solving many of the issues we are having. How dispiriting! Perhaps ignorance leaves them blind to the futility of this situation.

The look of disappointment when I can’t suggest a “quick fix” involving a slight tweak to the operating conditions, a clever way to equilibrate or flush the column, or an “allowable adjustment” to help system suitability criteria to be met frightens me. Some analytical methods are old, some are poorly designed, and some should never have been properly validated. These methods need to be redesigned in order for them to work to the requirements of a modern regulated laboratory environment (and I’m not just talking about pharmaceutical laboratories by the way). I can’t give you a tourniquet and frankly you don’t know how to suture, and even if you did it appears they are too expensive.

So, your method is validated and registered, but this really doesn’t mean it’s any good. I can cite you many methods (particularly legacy methods using old column technology, ion pairing reagents, sacrificial bases) that made it to manufacturing process control or QC and are absolutely horrible. There are also methods using older technology (columns as well as instrumentation) that would be much more “fit for purpose” if they were updated to use new column technology, new instrumentation, and new detector technology with advanced settings.

I’ve heard a thousand times about the “totally prohibitive costs” to redevelop, revalidate, and reregister methods, which is a massive barrier to making a bad method better. Why are we in this position? Why should we live with poor methods because it costs so much to change them in highly regulated environments? Surely, we have just priced ourselves out of quality improvement? We need to address this issue, and it needn’t herald the loss of control and method “fiddling” that so concerns quality assurance (QA) departments and regulators—we need to start this debate and we need to start it now.

I also hear often that “Bob” (the chromatography expert who used to work in the laboratory but left, or got laid off, or transferred) did some work on this method “back in the day”, but no one can remember what it was that he did, or can remember what the problem was, but the issue seems to have appeared again. So, Bob is gone, you don’t know what he did to solve the problem, and the laboratory manager is pushing for results, and even they are of an age now that they may not have the depth of knowledge or experience in chromatographic science that would allow them to help. Your investigational analysis team has been outsourced to China or India and you need to get some release testing (raw material analysis, cleaning validation, stability analysis) done and there is literally no one that can help. I can see you reaching for the tourniquet as we speak. It’s not your fault. It’s a product of the situation in which we find ourselves: of increasing instrument complexity and inaccessibility, increasing regulatory burden, decreasing focus on analytical science in higher education, and an industry attitude that chromatography is a support service where button pushers produce data that allows us to release product. What a sorry state.

In summary, the issues with solving an ongoing analytical problem in a regulated laboratory environment include:

  • A huge amount of pressure to get the results out of the door;
  • A poor understanding of analyte and separation chemistry and the fundamental principles of chromatography, which is hampering any root cause analysis using first principles;
  • A prohibitively large cost barrier to redeveloping and reregistering methods and therefore little chance of properly addressing issues in the short term
  • The chromatography expert left and the investigational analysis team has been offshored because chromatography is now an ancillary service, which is almost fully industrialized, and therefore expensive experts are not required locally to support this function.

We are running out of tourniquets, no one knows how to suture, and to be honest, even the sticking plasters are a little thin on the ground.

What are we going to do about it?


References

  1. Incognito, The Column 12(21), 11–13 (2018).

Contact author: Incognito
E-mail: [email protected]

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Wednesday, April 18, 2018

Opiant Pharmaceuticals Awarded Grant of Approximately $7.4 Million from the National Institutes of Health for Development of OPNT003, Intranasal Nalmefene, for Treatment of Opioid Overdose

Grant Expected to Fund Development of OPNT003 to NDA Ready Stage

SANTA MONICA, Calif., April 18, 2018 (GLOBE NEWSWIRE) — Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions, today announced that it has been awarded a grant of approximately $7.4 million from the National Institutes of Health’s National Institute on Drug Abuse (NIDA) for the development of OPNT003 (intranasal nalmefene), a long-lasting opioid antagonist for the treatment of opioid overdose. The grant includes approximately $2.6 million to be funded for the period ending March 31, 2019, with the balance to be funded over the subsequent two years.

“We view this NIDA grant as further validation of the potential for OPNT003 to be an important treatment for opioid overdose, a growing U.S. health epidemic,” said Roger Crystal, M.D., Chief Executive Officer of Opiant.  “Fentanyl was responsible for more overdose deaths (in excess of 20,000) than either heroin or prescription opioids in 2016.  Recognizing the evolution of the opioid crisis, the National Institutes of Health has called for the development of stronger, longer-acting overdose reversal products in order to address this next wave of potent synthetic opioids, like fentanyl. We look forward to using this grant to continue the development of OPNT003.”

“The receipt of this grant is reflective of our aim to maximize non-dilutive financing to support our research and development programs,” said David O’Toole, Chief Financial Officer of Opiant. “Over the last five months, we have also announced the return of our royalty stream from Adapt Pharmaceuticals and the receipt of funds from the exercise of warrants, which have further strengthened our balance sheet.”

The grant follows encouraging data from a Phase I clinical study of OPNT003 and a subsequent recent meeting with the U.S. Food & Drug Administration (FDA).  Based on FDA feedback, Opiant intends to pursue a 505(b)(2) development path and anticipates the potential to submit a New Drug Application (NDA) for the drug and intranasal delivery device combination in 2020. The 505(b)(2) development path allows certain information required for NDA approval to be derived from studies not conducted by Opiant.  Nalmefene for injection was previously approved by the FDA for treating suspected or confirmed opioid overdose.

Opiant was awarded this grant, to be funded over the next three years, following an in-depth evaluation by NIDA of the Company’s proposed research for scientific and technical merit. Opiant retains full commercial rights to OPNT003.

About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing pharmacological treatments for addictions. The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Opiant’s first product, NARCAN® Nasal Spray, is approved for marketing in the U.S. and Canada by its partner, Adapt Pharmaceuticals. For more information please visit: www.opiant.com.

Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

CONTACTS:
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Managing Director
LifeSci Advisors, LLC
Daniel@lifesciadvisors.com
(617) 535-7746

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N4 Pharma Starts Clinical Trial Of Reformulated Sildenafil

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LONDON (Alliance News) – N4 Pharma PLC said Wednesday that it has commenced proof of concept clinical trial for erectile dysfunction treatment drug sildenafil, following the completion of the validation of the reformulated drug.

The pharmaceutical company said the trial will comprise a four way crossover study in 12 healthy subjects comparing N4 Pharma’s reformulated 100 milligram sildenafil to Viagra 50 milligram in both fed and fasted conditions. The trial is expected to take eight to 10 weeks with provisional results data available in July, with the final clinical study report expected at the end of August.

N4 Pharma said the trial will enable the company to establish whether its reformulation has been sufficiently successful to allow N4 Pharma to prepare for a pre-IND meeting with the FDA towards the end of this year or whether further amendments are required to optimise efficacy.

“The board continues to believe that the improvements sought to be evidenced through the Trial will make our reformulation that much more attractive to both the end consumer and pharmaceutical partners in the final development and commercialisation of the drug in this highly lucrative market,” said Chief Executive Nigel Theobald.

Shares in N4 Pharma were trading 1.0% higher at 22.96 pence Wednesday.

By Tapan Panchal; [email protected]

Copyright 2018 Alliance News Limited. All Rights Reserved.

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Best Practices for Analyzing Pesticides and Their Metabolites in Environmental Samples

When a company wishes to commercialize a new pesticide, they must conduct environmental studies and develop analytical methods capable of detecting the pesticide, and its metabolites, in soil and water samples. The methods must be robust and rugged, for easy use in routine analysis. James Stry, a principal investigator at FMC Agricultural Solutions, recently talked to LCGC about best practices he and his team have established for developing such methods, including approaches to meeting a variety of requirements of regulatory bodies, simplifying sample preparation, dealing with matrix effects, choosing an ionization method, and streamlining method development.

When you are developing environmental methods for the registration or re-registration with the U.S. Environmental Protection Agency (EPA) of a new pesticide, what exactly do you have to demonstrate?

We must demonstrate that the methods we develop extract the environmental residue of concern from soil or sediment and that the residue is accurately quantified. To demonstrate the performance of the extraction method, we treat soil samples with radiolabeled compounds and age them in conditions representative of the environment. Aging the treated soil or sediment allows for the environmental metabolites to form and for the soil to become representative of a sample collected from the environment. We then extract the aged samples and analyze the radioactivity in the extract and the amount of radioactivity remaining in the soil. We test different extraction solvents, extraction techniques (for example, bead mill, sonication, or microwave), and the number of extractions conducted until close to all of the significant residue is extracted from the sample.

Once we have an extraction method, we fortify untreated control soil or sediment samples with known amounts of the analytes of interest. We then extract and analyze these samples and compare the concentration determined using the method to the known amount added to the control samples. The amount determined must be between 70% and 120% of the amount added for the method performance to be acceptable.

In addition to meeting the requirements of the U.S. EPA, do you also have to meet requirements for other regulatory bodies, such as those of other countries, if your products will be sold abroad, or of individual states within the United States? If so, how do you balance meeting all the requirements?

In an attempt to minimize additional method development work, we develop our methods to meet the most conservative requirements and test our methods on soil collected from all parts of the world. Currently, the European Union (EU) has some of the most conservative requirements for environmental methods. These requirements are described in the SANCO 825 Revision 8.1 guidance document (1). Once validated, the environmental methods can be sent to support compound registrations anywhere. An example is the residue method for chlorantraniliprole in crops (2). This method was validated on 21 different crops at a limit of quantitation of 0.010 mg/kg. This method has been accepted by regulatory agencies around the world for data collection and maximum residue limit (MRL) enforcement.

What are typically the biggest challenges in developing methods for detecting a pesticide and its metabolites in soil or sediment? What are the biggest challenges for detecting them in water?

Minimizing matrix effects is a major challenge when developing environmental methods. Since our methods are intended to analyze samples from grower fields, a suitable control sample will not always be available. Therefore, preparing standards in untreated control extracts may not always be an option. Moreover, the U.S. EPA prohibits the use of matrix-matched standards in all monitoring and enforcement methods (3).

Developing selective cleanup steps is one way to deal with matrix effects. However, the number and diversity of metabolites in the methods and the low limit of quantitation (1.0 µg/kg or below) makes method development a challenging task. The diversity of metabolites makes it difficult to develop one cleanup procedure capable of removing co-extracts while keeping all of the analytes of interest in a single extract. Keeping all of the compounds in a single extract limits the selectivity of the cleanup procedure.

Developing chromatographic separations using ultrahigh-pressure liquid chromatography (UHPLC) columns or solid-core particles can help minimize matrix effects as well. The sharp peak shape these columns produce lowers the instrument detection level, allowing additional dilution of the extracts. Dilution is perhaps the best way to minimize matrix effects. Instrument manufacturers continue to produce faster, more sensitive, and more-rugged instruments that have allowed us to simplify and streamline our methods. The speed of the newest generation of instruments allow for positive–negative switching without significant loss of sensitivity. This capability has removed the need to separate positive- and negative-ionizing compounds chromatographically or to analyze them in multiple chromatographic runs.

Water samples, although less complicated than soil or sediment, can be just as challenging. Water methods usually have a limit of quantitation of 0.10 µg/L or lower. For methods that include many metabolites, the analytes may need to be extracted from the water samples using solid-phase extraction (SPE) or a liquid–liquid partition step. Once the extract is concentrated, a solvent-exchange step may be needed before analysis. At the low levels analyzed in these methods, minor water contaminants can complicate quantitative analysis.

Over the years, have you developed best practices or streamlined approaches to developing these methods?

When developing the extract purification procedures, we tend to use a systematic approach. Before extracting any samples, we test evaporation and reconstitution steps, liquid–liquid partitions, and SPE procedures. When developing SPE procedures, we filter the analytes through columns in a variety of solvents to determine when they are retained and when they are eluted. Once we retain the analytes on a cartridge, we wash the cartridges with progressively stronger solvents until we have a complete profile of the properties for all analytes. Having all of this information allows us to understand how the analytes behave and to piece together an efficient and effective cleanup procedure.

We prefer to include all of the known metabolites in the methods. If the compound is not detected in the terrestrial field soil dissipation studies or if it does not show any adverse ecotoxicology effects, it can be removed from the method. We refer to this approach as comprehensive method development. We validate our methods in this manner because the addition of a new metabolite to an existing method often results in completely reworking the method, which can be time- and resource-intensive.

In environmental analysis, a challenge is often the complex matrix, which requires effective sample cleanup and preparation. Do you have “go-to” sample cleanup or preparation approaches for certain classes of products?

When developing our methods, we usually start with the most difficult soil or water samples. The idea is that if the method works for the most complex samples it will perform well for the other samples. For soil samples, we start with a high clay, high organic matter soil. We have found this combination results in an extract that is very difficult to purify and analyze. For water samples, we usually start with a pond-water sample.

The methods developed are based on the analytes included in the analysis. When developing methods for polar metabolites, some of the reversed-phase polymer SPE cartridges can be very effective at concentrating the sample extracts. We usually try to develop cleanup procedures that complement the separation and detection methods. If we are using reversed-phase LC we will try to develop an ion-exchange cleanup. If we are using an alkyl SPE cartridge (such as C18 or C8) for the cleanup step, we will develop a separation using a phenyl or biphenyl column. The overall goal is to minimize matrix effects by taking advantage of multiple physical-chemical properties of the analytes.

What percentage of your methods use gas chromatography (GC) and what percentage use LC? Has there been any change in recent years in that balance?

Almost all of the methods we develop are LC methods. Many of our active ingredients are thermally labile, limiting the use of GC analysis. The inclusion of multiple metabolites to these methods also limits the amount of GC analysis we conduct. Often, the metabolites we are analyzing are small polar alcohols or weak acids that are not amenable to GC analysis without derivatization. Although derivatization procedures can be developed, they can be time consuming and add complexity to the methods. It is also worth mentioning that relative to LC analyses, we have generally observed more severe matrix effects when conducting GC analyses.

What type of mass spectrometry (MS) detection do you typically use?

We typically use LC–MS/MS detection on triple-quadrupole instruments. Given that we are analyzing a limited number of known compounds using a reference standard, we can set up several multiple-reaction monitoring (MRM) transitions at the retention time of each analyte. In addition to being very sensitive, this approach allows for confirmation and quantitation during a single analysis. An added benefit is the availability of triple-quadrupole instruments in contract and monitoring laboratories. Using similar equipment allows for our methods to be transferred and revalidated at the laboratories performing the analysis with minimal modifications.

When do you use atmospheric pressure chemical ionization (APCI) MS, rather than electrospray ionization (ESI)?

When developing a new method, we usually start with ESI because often it is more sensitive than APCI. If we determine matrix effects are affecting method performance, we attempt to develop a cleanup procedure that is efficient and effective at minimizing the matrix effects. If, because of the number or diversity of the analytes, the cleanup procedure is not effective, is not rugged, or is very complicated, we switch to the APCI ion source. Although less sensitive, APCI usually does not exhibit the same degree of matrix effects as ESI. Given the reduced sensitivity of APCI, we adjust the injection volume, aliquot factor, or the sample’s final volume to reach the required detection level (2). Not all of the compounds we monitor can be ionized using APCI because of the increased temperature of the ion source and the gas-phase ionization mechanism. For compounds that are not amenable to APCI we return to ESI and look for new extract cleanup steps or better chromatographic separations until a robust method is developed.

How do you balance the need for sample preparation methods that are effective but not overly complicated or time consuming?

We need to strike a balance between the amount of sample cleanup, the time required to conduct the analysis, and the overall method performance. Cleanup can be time consuming and tedious work. However, without adequate cleanup, a method will perform well for only a limited number of sample types because of matrix effects or could result in false positives as a result of coeluted peaks. Reducing sample cleanup in favor of longer chromatographic separations limits the number of samples that can be analyzed per instrument each day.

Because of the large sample size (2–5 g) required to produce a representative soil or sediment sample, we have not implemented the 96-well format or other automated sample preparation approaches. We have seen significant improvements in efficiency using bead mill extractors, however. Bead mill extractors show excellent extraction efficiency of incurred residues and require less solvent per sample, and all of the equipment used is disposable, reducing the probability of sample contamination. The biggest advantage of bead mill extractors is the amount of time required to perform an extraction. An extraction requiring 20–30 min on a wrist action shaker or in a sonicating bath can be completed in 2–3 min using a bead mill.

Our goal is to develop a method with an efficient and rugged cleanup procedure and a set of chromatographic conditions that allow for adequate sample throughput without compromising the accuracy of the analysis.

References

(1) European Commission, Directorate General Health and Consumer Protection. “Guidance Document on Residue Analytical Methods,” SANCO/825/00 rev. 8.1, November 16, 2010.

(2) J. Grant, C.A. Rodgers, C.D. Chickering, S.J. Hill, and J.J. Stry, J. AOAC Int. 93(4), 1293–1301 (2010).

(3) U.S. EPA Ecological Effects Test Guidelines: OCSPP 850.6100: Environmental Chemistry Methods and Associated Independent Laboratory Validation.


James StryJames Stry is a principal investigator in the Regulatory Analytical Group at FMC Agricultural Solutions.Before joining FMC in 2017, he was with DuPont Crop Protection for 20 years. He is responsible for monitoring the global regulatory environment as it pertains to the residue and environmental analysis of crop protection compounds.In addition, he also maintains an active laboratory program developing new residue and environmental methods to meet regulatory requirements.Stry graduated from the State University of New York at Buffalo with a PhD in physical chemistry.

 

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Healthcare Analytical Testing Services Market – Global Forecast to 2023 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Healthcare
Analytical Testing Services Market by Type (Method Validation,
Environmental Monitoring, Bioanalytical Services, Stability, Raw
Materials, & Microbial Testing), End User (Pharmaceutical, Medical
Device Companies) – Global Forecast to 2023”
report has been
added to ResearchAndMarkets.com’s offering.

The Healthcare Analytical Testing Services Market is Expected to Reach
USD 5.97 Billion by 2023 from an Estimated USD 3.43 Billion in 2018, at
a CAGR of 11.7%.

The shift of focus towards analytical testing of biologics and
biosimilars, increasing outsourcing of analytical testing by
pharmaceutical companies, increasing acceptance of the QbD approach in
pharma research/manufacturing, and adoption of FTE contracts in R&D
outsourcing are the major factors driving the growth of the healthcare
analytical testing services market.

However, factors such as the pricing pressure faced by market players
and shortage of skilled professionals in the healthcare analytical
testing services industry are limiting the adoption of healthcare
analytical testing services up to some extent during the forecast period.

North America held the largest share of the global healthcare analytical
testing services market in 2017. On the other hand, the APAC region is
expected to witness the highest CAGR during the forecast period, due to
the increasing R&D funding, growing number of CROs, and favorable
government initiatives to promote pharmaceutical and biopharmaceutical
industries in several APAC countries.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Industry Insights

7 Healthcare Analytical Testing Services Market, By Type

8 Healthcare Analytical Testing Services Market, By End User

9 Healthcare Analytical Testing Services Market, By Region

10 Competitive Landscape

11 Company Profiles

  • Charles River
  • Envigo
  • Eurofins Scientific
  • Exova
  • Intertek
  • Labcorp
  • MPI Research
  • Merck KGaA
  • Pace Analytical
  • Pharmaceutical Product Development, LLC (PPD)
  • SGS
  • Source Bioscience
  • Wuxi Pharmatech

For more information about this report visit https://ift.tt/2qCnfVa

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Tuesday, April 17, 2018

Global Healthcare Analytical Testing Services Market 2018-2023 by Method Validation, Environmental

The global healthcare analytical testing services market is projected to reach USD 5.97 Billion by 2023 from USD 3.43 Billion in 2018, at a CAGR of 11.7%.

The shift of focus towards analytical testing of biologics and biosimilars, increasing outsourcing of analytical testing by pharmaceutical companies, increasing acceptance of the QbD approach in pharma research/manufacturing, and adoption of FTE contracts in R&D outsourcing are the major factors driving the growth of the healthcare analytical testing services market.

The report analyzes the global healthcare analytical testing services market by type, end user, and region. On the basis of type, the bioanalytical testing segment accounted for the largest share of the global healthcare analytical testing servicess market in 2017. The large share of this segment is due to increasing number of drugs in the biopharmaceutical pipeline and the growing biopharmaceutical industry.

The global healthcare analytical testing services market by end user is segmented into pharmaceutical and biopharmaceutical companies, medical device companies and contract research organizations. In 2017, the pharmaceutical and biopharmaceutical companies segment accounted for the largest share of the market. The large share of this segment can be attributed to the increasing outsourcing of analytical testing services by pharmaceutical and biopharmaceutical companies to boost profit margins, avoid high capital expenditure, and reduce the time required to validate the process and product.

The rising demand for specialized analytical testing services and growth opportunities in emerging APAC countries are expected to provide further growth opportunities for players operating in the healthcare analytical testing services market. However, pricing pressure faced by market players and shortage of skilled professionals in the healthcare analytical testing services industry are some of the factors limiting the growth of this market during the forecast period.

Eurofins Scientific (Luxembourg) held the leading position in the global healthcare analytical testing services market in 2017. Over the past three years, the company has established itself as one of the leading players in the healthcare analytical testing services market.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights
4.1 Healthcare Analytical Testing Services Market Overview
4.2 APAC: Healthcare Analytical Testing Services Market, By End User & Country
4.3 Healthcare Analytical Testing Services Market: Geographical Snapshot
4.4 Healthcare Analytical Testing Services Market: Geographical Mix

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Focus on Analytical Testing of Biologics and Biosimilars
5.2.1.2 Increasing Preference for Outsourcing Analytical Testing
5.2.1.3 Rising Adoption of the Quality By Design Approach
5.2.1.4 Adoption of Fte Contracts in R&D Outsourcing
5.2.2 Restraints
5.2.2.1 Pricing Pressure Faced By Major Players
5.2.2.2 Shortage of Skilled Professionals
5.2.3 Opportunities
5.2.3.1 Rising Demand for Specialized Analytical Testing Services
5.2.3.2 Growth Opportunities in Emerging Asia Pacific Countries
5.2.4 Challenges
5.2.4.1 Innovative Formulations and Medical Devices Demanding A Unique Analytical Testing Approach
5.2.4.2 Development of Appropriate Dissolution Methods
5.2.4.3 Growing Need to Improve the Sensitivity of Analytical Methods

6 Industry Insights
6.1 Industry Trends
6.1.1 Growing Industry Consolidation
6.1.2 Long-Term Outsourcing and Preferred Vendor Partnerships
6.2 Regulatory Analysis

7 Healthcare Analytical Testing Services Market, By Type
7.1 Introduction
7.2 Bioanalytical Testing
7.2.1 Cell-Based Assays
7.2.2 Virology Testing
7.2.2.1 In Vitro Assays
7.2.2.2 In Vivo Assays
7.2.2.3 Species-Specific Viral Pcr Assays
7.2.3 Immunogenicity & Neutralizing Antibody Testing
7.2.4 Biomarker Testing
7.2.5 Pharmacokinetic Testing
7.3 Physical Characterization
7.3.1 Laser Particle Size Analysis
7.3.2 Thermal Analysis
7.3.3 Image Analysis
7.3.4 Surface Area Analysis
7.3.5 Other Physical Characterization Analysis Services
7.4 Method Development & Validation
7.4.1 Extractables & Leachables Method Development & Validation
7.4.2 Process Impurity Method Development & Validation
7.4.3 Stability Indicating Method Validation
7.4.4 Cleaning Validation Method Development
7.4.5 Analytical Standard Characterization
7.4.6 Technical Consulting
7.4.7 Other Method Validation Services
7.5 Raw Material Testing
7.5.1 Complete Compendial Testing
7.5.2 Heavy Metal Testing
7.5.3 Container Testing
7.5.4 Karl Fischer Analysis
7.5.5 Wet Chemistry Analysis
7.5.6 Other Raw Material Testing Services
7.6 Batch-Release Testing
7.6.1 Dissolution Testing
7.6.2 Elemental Impurity Testing
7.6.3 Disintegration Testing
7.6.4 Hardness Testing
7.6.5 Friability Testing
7.6.6 Other Batch-Release Testing Services
7.7 Stability Testing
7.7.1 Drug Substance Stability Testing
7.7.2 Formulation Evaluation Stability Testing
7.7.3 Accelerated Stability Testing
7.7.4 Photostability Testing
7.7.5 Comparative Stability Testing
7.7.6 Other Stability Testing Services
7.8 Microbial Testing
7.8.1 Microbial Limit Testing
7.8.2 Sterility Testing
7.8.3 Endotoxin Testing
7.8.4 Preservative Efficacy Testing
7.8.5 Water Testing
7.8.6 Other Microbial Testing Services
7.9 Environmental Monitoring
7.9.1 Air Testing
7.9.2 Wastewater/ETP Testing
7.9.3 Other Environmental Monitoring Services

8 Healthcare Analytical Testing Services Market, By End User
8.1 Introduction
8.2 Pharmaceutical & Biopharmaceutical Companies
8.3 Medical Device Companies
8.4 Contract Research Organizations

9 Healthcare Analytical Testing Services Market, By Region

10 Competitive Landscape
10.1 Overview
10.2 Market Share Analysis
10.3 Competitive Scenario
10.3.1 Acquisitions
10.3.2 Expansions
10.3.3 Partnerships, Agreements, and Collaborations
10.3.4 Services Launches

11 Company Profiles
11.1 Eurofins Scientific
11.2 Labcorp
11.3 SGS
11.4 Charles River
11.5 Wuxi Pharmatech
11.6 Pharmaceutical Product Development, LLC (PPD)
11.7 Exova
11.8 Pace Analytical
11.9 Envigo
11.10 Intertek
11.11 MPI Research
11.12 Merck KGaA
11.13 Source Bioscience

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Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

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Five expert views on Track and Trace

European Pharmaceutical Review’s roundtable devoted to track and trace technology. Five industry experts focus on how the contribution of track and trace technology is shaping the pharmaceutical sector and explain what factors are driving that change.

What are the key elements of a successful track and trace system for the pharmaceutical sector?

Five expert views on Track and TraceETTORE CUCCETTI, CEO, ACG Inspection: For the successful implementation of a pharmaceutical serialisation system, understanding of the packaging process, country-specific regulations, in-depth knowledge of process compliance and, most importantly, the right implementation partner are crucial. Implementation partners must possess skills such as project management expertise, service and maintenance capability, and financial stability. Also, as these projects are more of a software deployments scenario ranging from medium- to large-size scope, then system validation, security, handling and maintenance of large quantities of data is critical to the business.

Selection of lean architecture-based software solutions along with modular hardware design is a must, not only to drive changes in current packaging processes, but also to accommodate future complex additional – or amendments to – regulations in the process.

Pharmaceutical companies also need to consider minimal disruption to existing processes and its impact on productivity, to successfully reap the benefits from the serialisation system.

Five expert views on Track and TraceWILLIAM MINAEFF, SR Project Director, Adents: As a serialisation project progresses, there are many challenges that need to be faced and many sources of complexity. Serialisation failures most frequently come from not understanding the scope of a serialisation project. For example: not identifying all stakeholders and their requirements, regarding packaging, label change, supply chain, IT and enterprise resource planning.

There are five key elements of a successful track and trace serialisation solution for the pharmaceutical sector, which are:

  • Configurability; meaning no specific development needed, with easy updates and upgrades management, allowing for virtually no chance of human error
  • Scalability; meaning when the initial rollout phase is achieved, you can smoothly deploy serialisation on additional lines without repeating the whole process
  • Interoperability; meaning increased flexibility to choose the hardware that best fits your objectives, and uses any of your existing equipment when valuable for serialisation and minimises costs and delays in delivery
  • Site level management capabilities; meaning the most secured and efficient approach to cope with change management. Having a centralised single point from where you can manage all your configuration and processes will help facilitate configuration management, data exchange, reporting, change management and validation support as well as IT governance. Site level management capability minimises risks and helps prepare you to meet future track and trace challenges.

Five expert views on Track and TraceDR STEFAN OEING, Head of track and trace software department, Atlantic Zeiser Ltd: Beside powerful HW units, which can flexibly handle different packaging formats on all levels in combination with serialisation and track and trace coding (aggregation), the overall SW-System itself will become increasingly important. On Level 2 (Line Management), the SW solution must be able to communicate in real time to all involved HW-units and provide an accurate picture of the commissioning process. This also covers any kind of manual rework necessary during commissioning. After completing batch production, balancing of data must be possible between all physical units (moved into stock), and all data sent to Level 3 software (site manager). Afterwards, post-lot processes must be accurately managed through pre-defined workflows, covering the generation of all regulated reports, the assembling of any shipment, and the reporting to any higher level SW (internally or externally, Level 4 and Level 5). Finally, the interaction with a (national) database will assure that the status of each code is up-to-date and available for all relevant participants of the track and trace process.

Five expert views on Track and TraceYANIK BEAULIEU, Technology Leader, Optel Group: The key elements of a successful track and trace system are three-fold. First, the flexibility to interact with multiple third-party IT systems (ERP/ MES, EPCIS server, government instances, etc). Second, the reliability and ease of use to minimally impact productivity. Third, adaptability through consistency: every packaging line is different, yet constancy between all lines / equipment is important for users.

Five expert views on Track and TraceJOE LIPARI, Director of Cloud Products, Systech International: A successful track and trace system requires flexibility to meet the unique connectivity needs of your supply chain. All systems are not created equal, but all systems in pharma are validated. Having a track and trace system capable of interfacing with a myriad of systems requiring varying data and messaging standards is key to successfully integrating the supply chain.

What benefits do such systems deliver to industry and the consumers they serve?

ETTORE CUCCETTI: Implementation of a serialisation system will be beneficial across the pharmaceutical value chain right from the marketing authorisation holder (MAH) and contract manufacturing organisation (CMO), to the supply chain partner, pharmacies and end-consumer. The pharmaceutical companies will be benefited with advanced capabilities to improve the supply chain and data security between different stakeholders. A track and trace system helps to monitor and control the counterfeiting issue and ensures brand protection.

DR STEFAN OEING: Such systems fulfil legal requirements, which aim to protect the consumers against counterfeiting. But they can do much more; for example, monitor packaging systems as well as internal and external logistics processes. Based on this, processes can be optimised, and components with best vs. worst performance and/ or quality can be identified. This can take place in different locations, eg, at the pharmaceutical manufacturer or along the legal supply chain. The overall picture can also provide valuable market information for different regions. Serialisation and track and trace codes can also be used to establish direct communication to the consumer, which opens the door for generating customer loyalty and gaining valuable customer insight.

YANIK BEAULIEU: The main goal is obviously to secure the supply chain against the counterfeit product for the end user, but brand protection is also a significant benefit. Many other benefits could be named, such as minimising the impact of recalls, logistics and handling advantages during production/distribution. This leads to interesting avenues in the future. Those include stock shortage prevention, cold chain distribution control or the end user having access to more information about the product in their possession, including advertising and health recommendations.

JOE LIPARI: In a word, visibility. The holy grail of track and trace is having full transparency into where a product has been. The value this delivers to a consumer is the confidence that the product you or your loved ones are consuming is from a trusted source.

How has the importance of track and trace systems changed over the past 10 years?

ETTORE CUCCETTI: We have seen a major transformation in the perspective of customers over past decade – from meeting the mandates to utilising master data for the betterment of production planning and supply chain management.

Today, the implementation is not only limited to printing on cartons but also includes data management and data security.

The industry is now looking towards single source solution providers that help them through compliance adherence, creating significant value addition to business and consumer safety.

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Intellectual Property Protection in Cambodia

Cambodia is a developing country supported mainly by three pillars of economic development – agriculture, tourism and textiles. With an average growth of 7.6% from 1994 to 2015, Cambodia is the fastest growing ASEAN economy.

In line with Cambodia’s desire to modernise and increase its economic prosperity, there are developments taking place in the country’s intellectual property system, which indicate that the government is serious about fostering and promoting innovation and foreign investment.

We highlight below several avenues for securing patent rights in Cambodia.

Protection under the Patent Cooperation Treaty (PCT)

On 8 December 2016, Cambodia became bound by the PCT system. This means that any international patent application filed on or after 8 December 2016 automatically includes the designation of Cambodia. International applicants, if they so choose, are able to enter the national phase in Cambodia within 30 months from the earliest priority date. Furthermore, nationals and residents of Cambodia are entitled to file international applications under the PCT from 8 December 2016.

European patents to be recognized in Cambodia

A validation agreement between the European Patent Office (EPO) and the Cambodia Ministry of Industry and Handicraft (MIH) was signed on 23 January 2017, making Cambodia the first Asian country and the 4th non EPC Member State to recognize EPO granted patents. This validation agreement entered into force on 1 March 2018 and applicants are henceforth able to validate European patent applications and patents in Cambodia.

It should be noted that validation into Cambodia is only available for any European or international application filed on or after 1 March 2018.

The fee for Cambodia is EUR 180 and is payable at the time of validation for other EP contracting states. The applicant will also need to provide Khmer and English (if the EP application is not already in English) translations of the granted European patent and pay a publication fee to the MIH.

ASEAN Patent Examination Cooperation (ASPEC)

Launched on 15th June 2009, ASPEC is a regional patent work-sharing programme among the ASEAN Member State IP offices of Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, the Philippines, Singapore, Thailand and Vietnam. While the local search and examination fees at local IP offices still apply, search and examination results can be shared among the members to improve the quality of work, and reduce duplicative work for time and cost savings.

The use of the ASPEC system is recommended to applicants who are looking to file in multiple ASEAN jurisdictions and wish to expedite prosecution in these jurisdictions.

Patent Cooperation with Singapore

Patentees or applicants with a Singapore patent or patent application will be able to:

  1. Re-register the Singapore patent in Cambodia

Under this scheme, the Singapore patent must be in force at the time of the request, have a filing date on or after 22 January 2003 and meet Cambodian requirements for patentability.

  1. Submit IPOS-issued Search and Examination Report to Cambodia

Applicants may request that IPOS submit to the Cambodian patent office a copy of the final search and Examination Report together with the final specification of the related Singapore patent application. The first ever patent in Cambodia was granted via this system.

Cooperation for Facilitating Patent Grant (CPG) with Japan

Starting from 1st July 2016, patent applications already examined and granted in Japan can be used to accelerate related patent applications in Cambodia under this scheme. Participation of CPG requires that the Japanese patent application has the same priority date or filing date as the Cambodian patent application, the corresponding Japanese patent application has been granted, and all the Cambodian application claims correspond to the claims of the Japanese granted patent.

Exclusions to Patent Protection

It should be noted that inventions relating to pharmaceutical products are generally excluded from patentability in Cambodia. This stems from the fact that Cambodia is under the World Trade Organisation waiver, which allows Least Developed Countries (LDCs) to avoid granting and enforcing IP rights on pharmaceutical products until 2033. As defined in Cambodia’s Law of Management of Pharmaceutical, pharmaceutical products are:

“one or many kinds of substances which are primarily from chemicals, bio-products, microbes, plants combined in order to:

– use in the prevention or treatment of human or animal diseases,

  • use in the medical or pharmaceutical research or diagnosis,
  • change or support the functioning of the organs.”

Accordingly, this includes serum and vaccines, blood or blood products, traditional medicines and poisonous substances.

Chemical compositions and new chemical entities for non-medical uses are still patentable.

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Monday, April 16, 2018

Visualization Technology Increases Productivity for Batch Operations

Honeywell’s Experion Batch provides operators with improved visibility, simplified maintenance, and faster validation.

Honeywell Process Solutions (HPS) introduced a control technology solution that increases productivity for batch operations and speed-to-market of batch products by allowing operators to see an intuitive and comprehensive timeline of every task required to complete a product batch. Honeywell’s Experion Batch uses patent-pending visualization technology to provide batch automation processes with the benefits of distributed control capability. This approach provides operators with insights into upcoming events or potential delays, which make it easier for them to conduct multiple tasks, take appropriate actions sooner, and adjust next steps accordingly. It also makes operations less dependent on individual operator experience, which will help manufacturers overcome skill gaps at a time when more veteran operators are retiring.

Experion Batch is designed for industries including pharmaceuticals, for which manufacturers are challenged to increase operator efficiency and product quality while using fewer resources to reduce costs. The technology simplifies ongoing maintenance by eliminating the need for a centralized, dedicated batch server. This design enables engineering and maintenance personnel to take a unit controller out of service without affecting other units. Experion Batch also allows plants to easily transition from recipe testing to execution while reducing testing and validation efforts, and it is aligned with international batch standards ISA S88 and IEC 61512-1.

Source: Honeywell Process Solutions

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Visualization Tech Boosts Batch Ops

Gellan Gum Market Statistics, Facts, Share, Production Report 2018 – Pharmaceuticals

The Global Gellan Gum Market is expected to grow at a compound annual growth rate of 3.83% over the period 2018 to 2023. The market is expected to reach US$62.960 million by 2023 from a market size of US$50.257 million in 2017.

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Gellan Gum is an ingredient produced by culturing bacteria and helps in improving the quality of the product. Increasing demand of bakery products such as jelly jam, pudding, confectionary and others is the key driver of global gellan gum market. Growing global aging population and increasing demand for cosmetics and personal products is further driving the growth of gellan gum market across the globe. Gellan gum is currently being used as a multifunctional additive in various pharmaceutical products for oral, nasal, ophthalmic, and other applications due to its unique structure and beneficial properties. Thus, growing pharmaceutical industry owing to rising incidence of chronic diseases and growing healthcare industry across the globe will continue to propel the growth of global gellan gum market over the forecast period.

North America holds a significant share in the global market on account of growing applications of gellan gum in food & beverage and pharmaceutical industry in the region. The market in the Asia Pacific is expected to witness a high growth rate over the forecast period due to increasing production of gellan gum in this region.

Research Methodology :-

The first section of the report deals with detailed research methodology for calculating market size and forecasts, secondary data sources used and the primary inputs which were taken for data validation. This section also outlines various segments which have been covered as part of the report.

Market Dynamics :-

Next section provides comprehensive market dynamics through an overview section along with growth drivers, challenges and opportunities which exist in the current market. This section of the report also provides supplier and industry outlook as a whole; key industry, global and regional regulations which are determining the market growth and a brief technological aspect of gellan gum. Complete industry analysis has also been covered through Porter’s five forces model as a part of this report section.

Market Segmentation

Thirdly, Gellan Gum market has been segmented by type, application, and geography as below:

By Type :-

  • Low-Acyl Gellan Gum
  • High-Acyl Gellan Gum

By Application:-

  • Food and Beverage
  • Pharmaceuticals
  • Chemical
  • Cosmetics
  • Others

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By Geography :-

  • Americas
  • North America
  • South America
  • Europe Middle East and Africa
  • Europe
  • Middle East and Africa
  • Asia Pacific
  • Market Players

Finally, competitive intelligence section deals with major players in the market, their market shares, growth strategies, products, financials, and recent investments among others.

 Key industry players profiled as part of this report are ;

  • DSM,
  • Biopolymer International,
  • Xinjiang Fufeng Biotechnologies,
  • Hawkins Watts,
  • CP Kelco,
  • Hangzhou Gellan Solutions

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