Friday, May 4, 2018

Kibow Biotech to Participate in The Pediatric Academic Societies (PAS) 2018 Meeting, May 5-8, 2018

NEWTOWN SQUARE, Pa., May 4, 2018 /PRNewswire/ — Kibow Biotech is pleased to be exhibiting for the first time at The Pediatric Academic Societies (PAS) Meeting, May 5-8, 2018  in Toronto, Canada, (https://ift.tt/2parpjj ) where it will introduce its plan to develop clinical studies for pediatric CKD patients using its innovative dietary supplement product, Renadyl™, the first and only kidney health supplement formulated and developed with pharmaceutical like validation, which utilizes revolutionary “Enteric Dialysis®” technology.




The goal is to expose the pediatric nephrology and other professionals to the crucial role of the gut-kidney connection, dysbiosis, and modulation of the Gut Microbiome with its innovative “Enteric Dialysis®” technology.   Kibow Biotech is currently developing the pediatric formulation and clinical protocol for the proposed RCT studies.

With 20 years of R&D and clinical trial expertise, Kibow Biotech’s vision is to provide an inexpensive, convenient, and efficacious kidney health supplement that could be useful for over 300 million people suffering from CKD worldwide. Preliminary data looks promising showing not only an arresting of the decline of GFR, but stabilization and also in several of cases increased GFR in all stages of kidney disease with individuals standard care of therapy.   Kibow Biotech has also developed a similar technology Probiotics/ prebiotics all natural, safe, US FDA’s – Generally Recognized as Safe (GRAS) formulation targeted towards Gout/Hyperuricemia applications. The animal studies have been successfully completed with excellent outcomes; human studies to begin soon. 

Forward looking statements: This press release contains forward-looking statements that reflect management’s current views of future events, including the status of development of the dietary supplement formulation, Renadyl™, for kidney health in the USA and the possibility of its approval as a drug in some other countries according to respective governmental authorities. 

About Uremic Toxin Reduction Technology – also known as “Enteric Dialysis®”: Kibow’s novel “uremic toxin removal technology” addresses the diffusion of various uremic toxins into the bowel as a consequence of failing kidney function. The Company’s patented and proprietary dietary supplements, Renadyl™ (for humans) and Azodyl® for cats and dogs with moderate to severe kidney failure (a veterinary formulation licensed to Vetoquinol https://ift.tt/1irPmLC) consists of a combination of three specific probiotic microbial strains and chosen prebiotics.

Kidney health supplement with a pharma-like validation: Kibow Biotech is not a pharmaceutical company. Kibow products are not drugs and may not be considered as a treatment or a therapy. The dietary supplement formulation of Renadyl™ is not meant to cure, prevent or mitigate any disease. Actual results may differ significantly from the above forward-looking statements due to a number of factors, including but not limited to the possibility that Renadyl™ may not show evidence of clinical activity in each and every individual, due to various genetic factors or environmental factors including proper storage, and transportation conditions. Other factors that could cause or contribute to differences in actual results include, but are not limited to, whether or not the Company or any of its collaborators will be able to develop drug pathway using the technologies of the Company, whether the cash resources of the Company will be sufficient to fund operations as planned; reliance on key employees, especially senior management; the uncertainty of the Company’s future access to capital; the risk that the Company may not secure or maintain relationships with collaborators; and the Company’s dependence on intellectual property. The Company expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.

Investor & Media Contact:
Terrence O. Tormey
(610) 353-5130 or Email:  194527@email4pr.com

Cision View original content:https://ift.tt/2rk8Ahr

SOURCE Kibow Biotech, Inc.



Source link

FDA 21 CFR Part 11 Compliance – Validation Seminar 2018 (Washington DC, United States, June 28-29, 2018) – ResearchAndMarkets.com | National Business

Part 11 / Annex 11 Computer Systems Validation (CSV) is implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.

Spreadsheets are a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this results in spreadsheets being among the most under-documented systems used in GxP environments because:

Users regard them as part of the desktopThe ease with which applications can be built without much trainingThe data processing power that they can haveLack of knowledge that spreadsheets need to be validatedLack of knowledge on how to validate spreadsheets

Consequently, Spreadsheets have become low hanging fruit during FDA or other regulatory inspections and many warning letters have been issued.

Lecture 1: Types of SpreadsheetsLecture 2: Excel Validation at a High LevelLecture 3: FDA Use of Excel SpreadsheetsLecture 4: Excel Validation Master Plan (VaMP)

Lecture 5: Excel Risk Assessment & RequirementsLecture 6: Excel Functional & Design SpecificationLecture 7: Verification & Testing for Excel CSVLecture 8: Quality Assurance for Excel CSV

Laura Wood, Senior Manager

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:Pharmaceuticals,Drug Discovery,Pharmaceutical Manufacturing

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 05/02/2018 03:31 PM/DISC: 05/02/2018 03:31 PM

Copyright Business Wire 2018.



Source link

Integrated Systems Aid Data Integrity

The data that pharmaceutical manufacturers rely on to make quality decisions come from electronic systems, hybrid practices that incorporate both paper and software, or paper records alone. But the pressure is on, from FDA and regulatory agencies worldwide, to ensure the integrity of data supporting the product lifecycle, from drug discovery to product manufacture and, ultimately, release. The World Health Organization, FDA, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have each issued guidance in the past few years to improve data integrity in pharmaceutical manufacturing.

FDA, in its 2016 Data Integrity and Compliance with CGMP Guidance for Industry (1), noted it was seeing increasing violations of current good manufacturing practices (cGMP) stemming from data integrity infractions. Some of those violations were the result of an inability to audit temporary data that may have been entered, but not saved, into an electronic system. Within the industry, the expectation that data are attributable, legible, contemporaneous, original, and accurate (ALCOA) has been expanded to what is called ALCOA+. This new definition demands that the data also be complete, consistent, enduring, and available.
These “plus” concepts help give a datum context, especially during future reviews and audits. In other words, ALCOA+ takes into account not just the data, and associated metadata, that exist at the time of collection, it also shows a complete picture of the data throughout its life to ensure data integrity. It is no longer appropriate to just demonstrate that data were collected and verified; data must be shown to remain unadulterated, accurate, and attainable. This demonstration can only be done when there are controls around the data to prevent alteration, or measures in place to identify when data have been changed. It is noted that changing data is acceptable for appropriate reasons, such as the wrong entry (i.e., typing mistake) of a test result. It is not acceptable when data are changed just to meet a specification.

Integrated electronic solutions

Electronic data capture offers significant productivity and security enhancements over paper-based records, but also introduces new challenges for information technology departments, users, and regulators. Challenges include preservation of data, technical aspects of system integration and validation, and acceptance of electronic systems, which require a higher level of technical capability.

For confidence that data meet ALCOA+ standards, pharmaceutical companies and contract manufacturers are increasingly relying on integrated software solutions. Integrating the computerized systems that capture, collect, and archive data is one way to reduce the manual re-keying of data, thus reducing risk and improving integrity. Single data entry, coupled with the automatic transfer of that data across integrated systems, eliminates the possibility of human transcription errors and increases efficiency. Most significantly, it decreases lag time for manufacturing execution systems (MES) and production lines to receive data as they become available in a laboratory information management system (LIMS).

Without confidence in the integrity of data, such as quality and batch release data, there can be no confidence in the integrity of the drugs themselves. In today’s manufacturing environment, paper-based and disconnected data systems don’t have any way to ensure that data are accurate and consistent–that they have integrity–other than by involving extra steps of human review, which is not ideal. Reliance on human intervention increases risk, which can lead to unusable product, product recalls, and lost revenue associated with recalls; warnings, fines, or consent decrees; negative publicity; and most important, possible harm to trial subjects and patients.
Therefore, various pharmaceutical companies are adopting strategies that reduce reliance on human/manual systems and deploying computerized systems instead. Although there is no single software solution for the entire pharmaceutical process, there are integrated systems and platforms that cover specific portions of pharmaceutical processes and that can be interconnected.

Integrated systems reduce risks and enhance product quality by using automated and systematic checks to verify data integrity. For example, solutions that integrate a LIMS, electronic laboratory notebook (ELN), and laboratory execution system (LES) into a single platform can effectively gather and share data on samples, methods of analysis, analytical results, environmental monitoring, and more, between the systems. These systems can also be integrated to enterprise resource planning, MES, and manufacturing control, which further enhances data integrity and efficiency.

New focus on temporary data

One aspect of data collection and integrity that is gaining attention is temporary data, which are data entered into a computerized system but not saved to the database, either accidentally or intentionally. As results are entered into a LIMS data entry page, it remains in a temporary state until the analyst commits it to the database. While in its temporary state, the results can be changed by the user, even multiple times. Such changes might be deliberate in order to make a sample meet certain specifications.

For example, if the amount of product to be filled in a bottle relies on potency, an incorrect potency could cost the company money by adding too much to a bottle (reduced yield), by not adding enough (reprocessing), or by missing stability specifications (product recall). To err is human, and while not rampant, there is evidence of data tampering to fit specifications. Hence the focus on temporary memory.
FDA’s latest guidance (1) recommends placing this temporary data under control so it may be audited. Tracking any changes in temporary memory, therefore, increases the integrity of data and helps pinpoint when data are being manipulated into passing. This control can be achieved using dynamic auditing. Dynamic auditing tracks changes to data once it is entered into a data entry field and prior to the data being saved/committed to the database. Traditional auditing involves auditing of data after being saved/committed to the database.

Benefits of integrated platforms

Integrated platforms can overcome the many potential ways in which data might be modified. Values entered into a connected system, via connected instruments, are not susceptible to transcription errors. It is much more difficult to modify data without authorization within a LIMS, particularly when data come directly from a connected instrument, compared to a paper-based system that relies upon observation and accurate, manual recording. Informatics systems, for example, can be designed to automatically save all entered data, to prompt a user to provide a reason for making a change, and to include all data in the audit review record. In addition, data entered into an informatics system can be checked for accuracy as it is typed; for example, an informatics solution can be configured to recognize that a pH cannot possibly have a value of 15 or a length cannot be negative.

Data from a connected system is still only as accurate and consistent as the interface that connects the component parts. Therefore, thorough verification and validation testing is crucial to demonstrate the reliability of the interface. An integrated LIMS/ELN platform, for example, offers a higher level of protection because no data are transferred between the two systems; instead, each datum is stored exactly once. Removing the double data entry and the duplication of values between systems over an interface between separate LIMS and ELN platforms reduces risk.

Integration with manufacturing systems ensures data integrity by eliminating re-keying of data. The data are automatically transferred between interfacing systems, reducing the time lag between result generation and reporting, which can reduce overall production timelines.

Integrated software solutions can make it much easier to achieve compliance with regulations, such as FDA’s 21 Code of Federal Regulations Part 11 for electronic records and signatures (2) and the European Union’s Annex 11 for computerized systems in pharmaceutical companies (3). These solutions enable human readable and printable audit trails and compliant electronic signatures. Pharma companies should also make sure the platform complies with new guidance on auditing data stored in temporary memory, that it does not allow users to change data that are marked as having come directly from an instrument, and that it features modern, secure, Internet-enabled system-interfacing capabilities.

References

1. FDA, Draft Guidance, Data Integrity and Compliance with CGMP Guidance for Industry (CDER, April 2016).
2. CFR Title 21, Part 11
3. EC, Guide to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use–Annex 11: Computerized Systems, The Rules Governing Medicinal Products in the European Union Volume IV, Office for Publications of the European Communities, pp. 139-142 (Luxemburg, January 2011). 

Article details

Pharmaceutical Technology
Vol. 42, No. 5
Pages: 46–47

Citation

When referring to this article, please cite it as D. DiPalma and J. Vannest , “Integrated Systems Aid Data Integrity,” Pharmaceutical Technology 42 (5) 2018.

About the authors

Don DiPalma is director of Quality and Technical Services, and Jeff Vannest is senior director of Product Management, both at LabVantage, [email protected].

Source link

Sangamo Therapeutics Announces Senior Leadership Changes

“Curt has executed a series of significant pharmaceutical collaborations that have brought renewed validation to Sangamo’s innovative research and technology platform and has provided me valuable counsel on corporate strategy,” said Sandy Macrae, CEO of Sangamo. “We now have a strong balance sheet which enables us to pursue our strategy to retain ownership of our own products for development and potential commercialization in our chosen therapeutic areas. We wish Curt well in his new endeavor.”

Herberts, 37, joined Sangamo in 2010 as Director of Corporate Development. In 2015, he was promoted to Vice President of Corporate Development and in December 2016 to Senior Vice President and Chief Business Officer.

Sangamo today also announced the promotion of Michael Holmes, Ph.D. to Senior Vice President and Chief Technology Officer. Holmes joined Sangamo in 2001 and has served as Vice President of Research since 2015. During his tenure at Sangamo, he has pioneered the use of zinc finger nucleases (ZFNs) for genome editing in transformed and primary human cells, including hematopoietic stem cells and T cells. Holmes is a member of Sangamo’s Executive Leadership Team.

“Over the course of his career at Sangamo, Mike has led many of our most important research and technology projects and has developed vast knowledge in the field of genome editing. He commands the respect of academic and industry peers and of Sangamo colleagues, and I am pleased to promote him to Chief Technology Officer,” Macrae said.

About Sangamo Therapeutics 
Sangamo Therapeutics, Inc. is focused on translating ground-breaking science into genomic therapies with the potential to transform patients’ lives using the company’s platform technologies in genome editing, gene therapy, gene regulation and cell therapy. For more information about Sangamo, visit the Company’s website at www.sangamo.com.

Forward Looking Statements
This press release contains forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, references relating to the pursuit of our strategy to retain ownership of our own products for development and potential commercialization in our chosen therapeutic areas. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the dependence on third parties for clinical trial supply and conduct of clinical trials, the lengthy and uncertain regulatory approval process, uncertainties related to the timing of initiation, enrollment and completion of clinical trials, and whether clinical trial results will validate and support the safety and efficacy of our product candidates. There can be no assurance that the necessary regulatory approvals will be obtained or that Sangamo and its partners will be able to develop commercially viable therapeutics. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in Sangamo’s operations and business. These risks and uncertainties are described more fully in Sangamo’s Annual Report on Form 10-K and its Current Report on Form 8-K as filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Sangamo undertakes no duty to update such information except as required under applicable law.

 

Cision View original content with multimedia:https://ift.tt/2IaL1S8

SOURCE Sangamo Therapeutics, Inc.

Related Links


http://www.sangamo.com



Source link

How to Plan Smoke Studies

This article was published in Pharmaceutical Technology Europe, Volume 30, Issue 5, May 2018.

Airflow visualization studies (i.e., smoke studies) are conducted to confirm unidirectional airflow patterns within an aseptic processing facility. Static studies are intended to document that the airflows within the Class A/ISO 5 zones are unidirectional and cascade out to the zones with lower cleanliness requirements. Dynamic studies should document that airflow within the Grade A/ISO Class 5 filling lines is unidirectional and sweeping down and away from sterile equipment surfaces, container/closure systems, and product. Dynamic studies work to confirm that facility and equipment design, equipment operation, and personnel aseptic manipulations (i.e., interventions) do not disrupt the “first air” (i.e., air exiting the high-efficiency particulate air filters within the Class A zone essentially particle free, in a unidirectional manner) to critical areas where sterile surfaces, materials, and products are exposed.

Inadequate airflow (e.g., turbulence due to line design issues and first air disruption during interventions) in the critical Grade A zones, where sterile products and components are exposed, could lead to the introduction of contaminants into drug products as they are being filled and stoppered, posing a risk to product sterility. 

A product contamination risk can result if first air is disrupted by passing over non-sterile surfaces of equipment, tools, components, or operators on its way to exposed sterile product, components, and equipment. Any viable or non-viable matter on these non-sterile surfaces can be dislodged and introduced as contaminants into the sterile drug product.

A successful smoke study report will include a thorough analysis of the study, justifying that satisfactory airflow under static and dynamic conditions was achieved. If the smoke study finds unacceptable air flow (e.g., first air disruption by equipment operation and/or personnel interventions) or turbulence, an investigation should identify the root causes and recommend actions to be taken (e.g., filling line or equipment modification, change in personnel behavior/aseptic technique, adjustment of air velocities). 

Turbulent airflow may be acceptable in closed systems, such as an isolator, provided that studies demonstrate that acceptable particulate levels can be maintained. Smoke study video recordings are considered data that should be maintained as any other data generated on site. 

GMP requirements

Although the FDA good manufacturing practice (GMP) regulations do not specifically refer to smoke or airflow visualization studies, FDA has issued observations using FDA Form 483 and warning letters citing the lack of smoke testing or inadequate smoke testing to establish appropriate airflow that reference the following sections of 21 Code of Federal Regulations (CFR)Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals (1): 

211.113(b) Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of any sterilization process.

211.63 Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

21 CFR Part 211.113(b) is generally cited when the video shows operator activities are contributing to turbulence or the true air flow cannot be demonstrated based on the poor placement of the smoke source and camera angle. 

21 CFR Part 211.63 is generally cited when the video shows the line design/equipment placements are contributing factors to turbulence.

Elements of a smoke study protocol

Airflow smoke studies should be performed during qualification of new facilities, following changes in facilities impacting the sterile core (e.g., air-handling systems or aseptic processing equipment), and following changes/improvements in aseptic activities/interventions. 

The smoke study protocol should clearly define the objectives, responsibilities, tools to perform the study, and acceptance criteria for static and dynamic conditions. 

To ensure a strong smoke study, the following elements should be included in the plan:

  • Responsibilities for developing, implementing, reviewing, and approving the smoke studies
  • A floor diagram of each filling room including details within the filling line and the equipment, carts, etc. in the support areas surrounding the filling line (The floor diagram can mark the general position where the operator will perform each type of intervention, the general position of the smoke source and camera position(s) to effectively capture each intervention. These floor diagrams are helpful to identify to the inspector where the intervention is being performed and the location of the camera because some smoke study views are too close up to clearly show where on the line this is occurring.)
  • Type of smoke generators to use and smoke source (e.g., water for injection or deionized water heated and combined with liquid nitrogen or dry ice
  • Acceptance criteria, as applicable (see following section) 
  • Actions to take if acceptance criteria are not met (e.g., an investigation to determine the root causes and implementing a corrective action and preventive action [CAPA] to eliminate a recurrence of airflow disruption. Note that after implementation of the CAPA a new smoke study is performed.) 
  • The process for identifying each intervention shown on the video (e.g., a placard or slide can precede each intervention and/or narration as each intervention is performed).

Acceptance criteria include the following: 

  • Static conditions within the Grade A filling lines show unidirectional airflow patterns sweep down and/or away from the exposed product, product contact packaging components, and product contact surfaces.
  • Dynamic conditions within the Grade A filling lines show unidirectional airflow remains stable during interventions with no disruption of first air to critical areas where sterile surfaces, materials, and products are exposed. 
  • Air from outside the critical Grade A/ISO Class 5 area is not drawn into the critical zone during interventions.
  • Sufficient smoke should be generated to allow the smoke to merge with the airflow and visually display its direction.
  • The smoke source is positioned to allow sufficient smoke to enter the airflow over the operator and tools (e.g., forceps) during the intervention to visualize the impact of this activity on the airflow. As the operator and tool moves within the Grade A filling line during the intervention, gradually move the smoke source to follow these activities to allow continuous visualization of the impact of the operator’s activities to the first air.
  • Do not generate excessive smoke. The density of the smoke may prevent a clear view of the operator, the intervention, and impact on airflow. 
  • All interventions occurring in actual filling operations and simulated in media fills must be accurately simulated in smoke studies. Be prepared to provide a master list of all known interventions for each drug product filling operation by container/closure system on each filling line configuration and the supporting smoke study or smoke studies.
  • Include ergonomic considerations; if multiple personnel of different stature (e.g., short vs. tall) perform the same intervention in a different manner and/or require different tools or aids, include this in the smoke studies.
  • All filling line and filling room equipment configuration and placement represent those utilized in current routine processing and media fills. All applicable standard operating procedures and any other reference material that may be necessary to verify the accuracy of the room configurations, equipment operation, and personnel intervention should be referenced or attached, as necessary. 

Executing the smoke study protocol

Smoke studies are generally not a routine event performed at a recurring fixed timeframe in the same manner. New or additional smoke studies may involve changed or different filling rooms, different interventions, new or different smoke sources, different video cameras, or different personnel, for example. Given these variables and the cost, time, resources, and effort necessary to carry out a successful smoke study, it is best to carry out a rehearsal of these activities to identify any unforeseen barriers or limitations.Consider the following:

  • Determine where and how the smoke source(s) will be placed within the filling line. Based on space and design limitations, different types/sizes of smoke sources may be needed. 
  • Practice how the person holding the smoke source will follow the operator performing the intervention to ensure the smoke is always correctly positioned. Common errors occur when the smoke source is not held over the operator as he performs the intervention, not moving the smoke source as the operator moves, and having the smoke source in continuous motion, thus preventing a clear view of the impact of the operator on airflow.
  • Determine the positions for the camera to capture the operator performing the intervention in its entirety. For some interventions, based on the filling line design and space limitations, it may be necessary to video the activity from multiple angles to clearly show the impact of the intervention on the airflow. 

Ensure the persons responsible for taking the video have the skills to consider how variables such as distance, angle, lighting, camera movement, and other variables can impact the video to minimize the number of re-shoots necessary to capture the intervention and its impact on airflow clearly. The video shoot should have a director to manage and control all the personnel involved in performing the interventions, positioning the smoke source(s), and the videographer(s) to ensure the event is performed accurately, captured clearly and completely on video or, if not, repeated.

Large pharmaceutical companies with numerous and different types of aseptic filling operations and environmentally controlled support rooms may have communication and coordination challenges under some situations, such as when numerous smoke study teams work simultaneously, at times, around the clock to complete all smoke studies during the firm’s plant shutdown or when private smoke testing contractors and/or personnel from other corporate divisions or sites are brought in to assist in the smoke studies. Managing these diverse groups, some of which may have never worked together and may have differing views about smoke studies, will require close quality assurance (QA) oversight to ensure consistent implementation of the smoke study protocols. 

Smoke study final report

The smoke study report review process should not lose focus that a key element of the review is the video itself and not principally the unexecuted protocol that contains all the expectations. Upon execution, if the video does not clearly and unequivocally show the adequacy of airflow when interventions were performed accurately on the filling line set-up as currently used, acceptance criteria have not been met. The review of all the static and dynamic smoke study videos should involve subject matter experts (SMEs) from the various departments involved to ensure all depictions in the videos accurately represent current practices. 

The final QA review to assess compliance with acceptance criteria can be challenging and may benefit by having additional reviews by other QA and/or SMEs not actively involved in producing the smoke study. Having a separate set of reviewers to critically review and, as necessary, challenge any views that are not clear or subject to more than one interpretation, may pick up weaknesses not apparent to the initial reviewers, which are the type of weaknesses that may be detected by a regulatory inspector. 

Non-airflow issues evaluated in smoke studies

Static and dynamic smoke study videos may provide many different views and close-up views within the sterile core that are not visible or clearly visible through the view windows or cameras into these areas. These views can identify other GMP issues for a regulatory inspector to pursue. For example, a clear view of the aseptic technique used in complex interventions could lead to further review of the technique for reproducibility as practiced currently. When viewing the condition of gowning and compliance with gowning requirements, any differences with current gowning practices will be evaluated. A view showing the facility and equipment complexity of design, age, and surface condition (e.g., excessive number of scratches or deep scratches/gouges, deterioration, rust) can lead to questions about how these surface conditions may impact the ability of current practices to consistently and effectively clean, sanitize, and sterilize these surfaces. Questions about preventive maintenance and part replacement practices in these critical areas may also be pursued.

QA review of the smoke studies should not be limited to airflow issues but to the entire content of the video to ensure all GMP issues have been addressed, including those not directly related to airflow.

Conclusion

As is the case with media fills, smoke studies only document the conditions occurring at the time the studies were performed. QA and production department oversight should ensure the controls displayed in the smoke studies represent current practices used by all the other personnel performing similar activities but not involved in the smoke studies. Systems should be in place to detect, investigate, correct, and prevent recurrence of any variance from these controls and, as necessary, repeat the smoke study. 

This type of smoke study review and preparation can make the regulatory inspector’s review of smoke studies a relatively uneventful and routine step of the inspection, with the inspector generally satisfied with the videos.

Reference

1. CFR Title 21, Part 211.

About the author

Manuel M. Garza is a principal consultant with PAREXEL Consulting, a subsidiary of PAREXEL International, [email protected].

Article details

Pharmaceutical Technology Europe
Vol. 30, No. 5
Pages: 38–41

Citation

When referring to this article, please cite it as M. Garza, “How to Plan Smoke Studies,” Pharmaceutical Technology Europe 30 (5) 2018.

 

Source link

Pharmaceutical Analytical Testing Outsourcing Market Overview, Demand, Size, Growth & Forecast 2022- Worldwide Analysis – Expert Consulting

The Pharmaceutical Analytical Testing Outsourcing Market report mainly elaborate the definition, types, applications and major players of Pharmaceutical Analytical Testing Outsourcing markets in details. Deep analysis about market status (2012-2017), enterprise competition pattern, advantages and disadvantages of enterprise Products, industry development trends (2017-2022), regional industrial layout characteristics and macroeconomic policies, industrial policy has also be included.

Get Sample PDF of the Report@ https://ift.tt/2wa89Lv 

Pharmaceutical Analytical Testing Outsourcing Market Segment by Manufacturers includes West Pharmaceutical Services, Charles River Laboratories International, Toxikon, Pace Analytical Services, Eurofins Scientific, Boston Analytical, Exova Group, Pharmaceutical Product Development, Intertek Group, SGS SA.

From raw materials to downstream buyers of this industry will be analysed scientifically, the feature of product circulation and sales channel will be presented as well. In a word, this report will help you to establish a panorama of industrial development and characteristics of the Pharmaceutical Analytical Testing Outsourcing market.

This report categorize based on analysis of definitions, classifications, applications, types, share and industry chain structure.

Pharmaceutical Analytical Testing Outsourcing Market Segment by Type includes Bioanalytical Testing, Method Development and Validation, Stability Testing.

Pharmaceutical Analytical Testing Outsourcing Market Segment by Applications includes Hospital, Pharmaceutical Manufacturers, Others.

Pharmaceutical Analytical Testing Outsourcing industry split by Regions include North America, Europe, China, Japan, Middle East & Africa, India, South America, Others.

Pre Order Enquiry for Pharmaceutical Analytical Testing Outsourcing Market report @ https://ift.tt/2HLuFjf 

Some important points from Global Pharmaceutical Analytical Testing Outsourcing Market Research Report:

  1. Global Pharmaceutical Analytical Testing Outsourcing Production, Value ($) by Region (2012-2017)
  2. Global Pharmaceutical Analytical Testing Outsourcing Production, Consumption, Export, Import by Regions (2012-2017)
  3. Global Pharmaceutical Analytical Testing Outsourcing Market Status and SWOT Analysis by Regions
  4. Pharmaceutical Analytical Testing Outsourcing Product Introduction and Market Positioning
  5. Global Pharmaceutical Analytical Testing Outsourcing Market Analysis and Forecast by Type and Application
  6. Pharmaceutical Analytical Testing Outsourcing Market Analysis and Forecast by Region.

All aspects of the Pharmaceutical Analytical Testing Outsourcing report are quantitatively as well as qualitatively assessed to study the global as well as regional market comparatively. The basic information such as the definition, prevalent chain and the government regulations pertaining to the Pharmaceutical Analytical Testing Outsourcing market are also discussed in the report.

Source link

Thursday, May 3, 2018

FDA 21 CFR Part 11 Compliance – Validation Seminar 2018 (Washington DC, United States, June 28-29, 2018) – ResearchAndMarkets.com | Business

DUBLIN–(BUSINESS WIRE)–May 2, 2018–The “FDA 21 CFR Part 11 Compliance – Validation Seminar 2018” training has been added to ResearchAndMarkets.com’s offering.

Part 11 / Annex 11 Computer Systems Validation (CSV) is implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.

Spreadsheets are a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this results in spreadsheets being among the most under-documented systems used in GxP environments because:

Users regard them as part of the desktopThe ease with which applications can be built without much trainingThe data processing power that they can haveLack of knowledge that spreadsheets need to be validatedLack of knowledge on how to validate spreadsheets

Consequently, Spreadsheets have become low hanging fruit during FDA or other regulatory inspections and many warning letters have been issued.

Agenda

Day 1 Schedule

Lecture 1: Types of SpreadsheetsLecture 2: Excel Validation at a High LevelLecture 3: FDA Use of Excel SpreadsheetsLecture 4: Excel Validation Master Plan (VaMP)

Day 2 Schedule

Lecture 5: Excel Risk Assessment & RequirementsLecture 6: Excel Functional & Design SpecificationLecture 7: Verification & Testing for Excel CSVLecture 8: Quality Assurance for Excel CSV

For more information about this training visit https://www.researchandmarkets.com/research/wnfbcg/fda—21—cfr—part?w=4

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

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:Pharmaceuticals,Drug Discovery,Pharmaceutical Manufacturing

KEYWORD:

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 05/02/2018 03:31 PM/DISC: 05/02/2018 03:31 PM

https://ift.tt/2Kyww8Y

Copyright Business Wire 2018.

Source link

Wednesday, May 2, 2018

Seasoned Scientific Experts and Strategic Pharmaceutical Industry Veterans Join Cerenis’ Scientific Advisory Board in Oncology

TOULOUSE, France & LAKELAND, Mich.–(BUSINESS WIRE)–Regulatory News:

CERENIS Therapeutics (Paris:CEREN) (FR0012616852 – CEREN – PEA-PME
eligible)
, an international biopharmaceutical company dedicated to
the discovery and development of HDL-based innovative therapies for
treating cardiovascular and metabolic diseases, as well as new HDL-based
vectors for targeted drug delivery in the field of oncology, announces
the creation of its Scientific Advisory Board in Oncology (SAB-Oncology)
with five key appointments: Briggs Morrison, MD, who will
serve as the Chairman of the SAB, Mark Frohlich, MD, Aurélien
Marabelle
MD, PhD, Robert Schneider, PhD and Robert J.
Spiegel
, MD, FACP.

Jean-Louis Dasseux, founder and CEO of Cerenis, commented: “Cerenis
is fully committed to implement its strategy in targeted HDL drug
delivery. Creating this SAB in Oncology represents another important
step forward for the company following the asset acquisition of Lypro
Biosciences. More steps will follow as the company is leveraging its
leading expertise in HDL, its intellectual property, its unique
large-scale recombinant human apoA-I and HDL manufacturing and its
clinical experience in HDL development to create a unique HDL drug
delivery platform. Cerenis intends to develop products based on HDL drug
delivery to allow for selective targeting to effectively kill cancer
cells while protecting normal tissues. We are very happy to have such
prestigious leading experts bringing not only a wealth of experience
across research and clinical development, but also a hands-on experience
in pharmaceutical and drug development strategies. This is essential to
guide us in prioritizing and driving forward our drug delivery platform
and clinical programs in Immuno-oncology and Chemotherapy.”

Briggs Morrison, MD, SAB Chairman, commented: “I
am very enthusiastic about joining Cerenis’ Oncology Scientific Advisory
Board to help the company develop promising new products for
Immuno-oncology and Chemotherapy, and to help the Cerenis management
understand this exciting but complex field. Targeted drug delivery has
always been a ‘holy grail’ in Oncology and Cerenis may be at the point
where such a challenge can be overcome with novel HDL technology
developed by the company. For the first time we have pharmaceutical
grade HDL, that may act as a universal carrier for diverse payloads
including antigens, nucleic acids, and chemotherapeutic agents with a
high specificity toward the targeted cells.”

Mark Frohlich, MD, SAB member, commented: “The concept of
targeted delivery to cancer using nanoparticles is highly attractive.
However, historical nanoparticle platforms, such as liposomal
formulations, have failed to deliver on their promise. Challenges have
included difficulties in manufacturing a consistent product, poor in
vivo stability, and highly inefficient tumor targeting. The Cerenis HDL
platform holds great potential to overcome these challenges and deliver
on the promise of targeted nanoparticle delivery.”

The SAB-Oncology will work closely with Cerenis’ management team as it
develops its targeted HDL drug delivery platform in immuno-oncology and
chemotherapy and it is actively preparing to bring a lead product
candidate into clinical studies. The Company believes its targeted HDL
drug delivery platform has the potential to transform the treatment
paradigm in immuno-oncology and chemotherapy, a market representing more
than $30 billion. Cerenis is positioned to leverage its considerable IP
positions and manufacturing expertise to make unique contributions in
this important therapeutic space.

Briggs Morrison, MD: Chairman of Cerenis’ SAB Oncology – Former
Head of Global Medicines Development and Chief Medical Officer at
AstraZeneca

Briggs W. Morrison received his B.S. in biology from Georgetown
University, his M.D. from the University of Connecticut Medical School,
completed residency training in Internal Medicine at the Massachusetts
General Hospital, and completed a fellowship in Medical Oncology at the
Dana-Farber Cancer Institute. He did post-docs with Dr. Philip Leder at
Harvard Medical School, and Dr. Lee Nadler at the Dana-Farber Cancer
Institute. He joined Merck & Co., Inc. in 1995, where he held various
R+D positions including leading the Clinical Oncology Department.
Subsequently he was appointed Head of Clinical Development at Pfizer in
2007, and became the Head of Global Medicines Development and Chief
Medical Officer at AstraZeneca in 2012. He is currently the CEO of
Syndax Pharmaceuticals.

Dr. Morrison has overseen the development of numerous biopharmaceutical
products in multiple therapeutic areas, from First-In-Human trials
through to global regulatory approvals. He is currently a Board member
of private companies Oncorus and Repare Therapeutics, and is an advisor
to a number of other private biotechnology companies. In addition, Dr.
Morrison is a Board member of the Alliance for Clinical Research
Excellence and Safety (ACRES), a non-profit organization dedicated to
optimizing the global clinical research system.

Mark Frohlich, MD – Former Executive V.P. of Portfolio Strategy at
Juno Therapeutics

Dr. Mark Frohlich has been involved in the development of cellular
immunotherapies for cancer for more than 15 years. He was recently EVP
of Portfolio Strategy at Juno Therapeutics, prior to its $9 billion
acquisition by Celgene. He previously served as EVP of R&D and Chief
Medical Officer of Dendreon Corporation, where he led the clinical team
responsible for the approval of the first cellular immunotherapy in the
US and Europe (Provenge®). Prior to that he led the clinical team at
Xcyte Therapies, developing autologous activated T cells for cancer. Dr.
Frohlich is a medical oncologist. He is a graduate of Harvard Medical
School and Yale College.

Aurélien Marabelle, MD, PhD – Clinical Director of the Cancer
Immunotherapy Program at Gustave Roussy Cancer Center

Dr. Aurélien Marabelle’s clinical practice is dedicated to early phase
clinical trials in Cancer Immunotherapy. His translational research is
focused on mechanisms of action of immune checkpoint monoclonal
antibodies. He works as a senior medical oncologist and an investigator
in the Drug Development Department (DITEP) directed by Dr. Christophe
Massard. He is coordinating a team focusing on cancer immunotherapy
translational research projects in the INSERM U1015 lab directed by Prof
Laurence Zitvogel. Dr. Marabelle is a member of ESMO, ASCO, EATI and
AACR.

Robert Schneider, PhD – Albert Sabin Professor of Molecular
Pathogenesis, Professor of Radiation Oncology

Dr. Robert Schneider is associate Director of the NYU Cancer Institute,
Director of Translational Cancer Research, and Co-director of the Breast
Cancer Research Program at NYU School of Medicine.

He is also the Associate Dean for NYU Technology Ventures and
Partnerships, which has transformed NYU’s technology transfer and
commercialization into a leading therapeutics development and new
company academic enterprise. Dr. Schneider is also an active researcher,
and performs basic, translational, and clinical research on the
molecular basis of metastatic breast and ovarian cancers,
interconnections with the inflammatory response, and the development of
new therapeutics. He is the author of more than 160 peer-reviewed
publications. He has received a number of awards in recognition for his
achievements, including the 2012 Susan E. Donelan Hope for the Future
Award for breast cancer research from the Dana Farber Cancer Institute;
the 2011 Distinguished Alumnus Award & Commencement address from the
University of Delaware; the 2010 Judah Folkman Memorial lecture from the
Chemotherapy Society, among others. Dr. Schneider is a co-founding
scientist of six biotechnology/small pharmaceutical companies including
ImClone Systems (New York), PTC Therapeutics (New Jersey), Canji (San
Diego), Gencell (Paris) and ENB Therapeutics (New York). Dr. Schneider
received his Ph.D. in biomedical sciences from the Mount Sinai School of
Medicine and was a postdoctoral research fellow in the Department of
Molecular Biology at Princeton University.

Robert Spiegel, MD – Former Sr. V.P. for worldwide Clinical
Research and Chief Medical Officer at Schering-Plough

Dr. Spiegel has over 30 years of extensive R&D and operational
experience in biopharmaceuticals including Big Pharma, biotech, and
academic startups as well as interactions advising venture capital and
private equity.

Dr. Spiegel spent over 25 years at Schering-Plough where he joined as
the first Director for Oncology Clinical Research, and subsequently held
a series of senior executive positions, including Senior Vice President
for worldwide Clinical Research and Chief Medical Officer. During his
time at Schering-Plough he took numerous drug candidates through
clinical development and was involved with over 30 NDA approvals at the
FDA. For the last five years Dr. Spiegel has been a consultant to the
biotech industry and has served on the Boards of multiple biotech
companies He currently serves on the Boards of Directors of Geron Corp,
Edge Therapeutics, and Neximmune Inc. and is Chairman of Vidac
Therapeutics. He is currently the principal of Spiegel Consulting LLC
and an Assistant Professor of Medicine at Weill Cornell Medical College.
He is also a Senior Advisor to private equity firm Warburg Pincus and an
Advisor to the Israel Biotech Fund.

Dr. Spiegel received his B.A. from Yale University and his M.D. from the
University of Pennsylvania. He completed his specialty training at the
National Cancer Institute, National Institutes of Health (NIH).

About CERENIS: www.cerenis.com

CERENIS Therapeutics is an international biopharmaceutical company
dedicated to the discovery and development of innovative therapies for
the treatment of cardiovascular and metabolic diseases. HDL is the
primary mediator of the reverse lipid transport, or RLT, the only
natural pathway by which excess lipids is removed from arteries and is
transported to the liver for elimination from the body.

CERENIS is developing a portfolio of lipid metabolism therapies,
including HDL mimetics for patients with genetic HDL deficiency, as well
as drugs which increase HDL for patients with a low number of HDL
particles to treat atherosclerosis and associated metabolic diseases
including Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic
Steato-Hepatitis (NASH). Capitalizing on its expertise, Cerenis is
developing the first HDL-based targeting drug delivery platform
dedicated to the oncology field (immuno-oncology and chemotherapy).

CERENIS is well positioned to become one of the leaders in the HDL
therapeutic market, with a broad portfolio of programs in development.

About Targeted HDL Drug Delivery

HDL particles, loaded with an active agent, hold the promise to target
and selectively kill malignant cells while sparing healthy ones. A wide
variety of drugs can be embedded in these particles targeting markers
specific to cancer cells and bring these potent drugs to their intended
site of action, with lowered systemic toxicity. Cerenis intends to
develop the first HDL-based targeting drug delivery platform dedicated
to the oncology market, including immuno-oncology and chemotherapy.

Financial Agenda:
Annual Shareholder Meeting: June 25th,
2018

Source link

ValGenesis and PharmOut Announce a Partnership Founded on a Paperless Validation Initiative.

New partnership offers cost-effective paperless validation to GMP-governed organisations in Australia

ValGenesis and PharmOut
Announce a Partnership Founded on a Paperless Validation Initiative.

New partnership offers cost-effective
paperless validation to GMP-governed organisations in Australia

Cost-effective
paperless validation now available to Australian GMP-governed organisations
with announcement of new partnership

Melbourne,
Australia, April 27 2018.

 

PharmOut, the Asia
Pacific’s leading Pharmaceutical consulting organization, has announced a strategic
partnership with ValGenesis Inc, a pioneer in paperless validation software
systems.

Pharmaceutical,
medical device and other industries that must be compliant with Good
Manufacturing Practice (GMP) incur considerable costs in creating, maintaining
and storing the mountain of paper documents required for the routine operation
of their manufacturing facilities. Australian companies have also long
struggled with a shortage of experienced validation professionals, further
adding to their costs.
 

This new
partnership offers a cost-effective and innovative validation solution to
Australian companies. Combining the expertise of PharmOut’s large team of
validation consultants with the ValGenesis Validation Lifecycle Management
System will deliver faster, cheaper validation services in Australia. It will
also deliver all the advantages a paperless system offers, making Australian
manufacturers more competitive in global markets.

PharmOut’s
founder, Trevor Schoerie said: “As the largest provider of outsourced
validation services in the Asia Pacific region, our customers were asking us
for ways they could slash both the cost and time required to meet their
validation obligations. We evaluated the available software solutions and found
that ValGenesis was the stand-out product. We realised that we could train our
consultants to become experts in the ValGenesis software, allowing us to fast
track the delivery of validation services, whilst also providing all the
benefits of a paperless solution to our customers.”

“By allowing
life science companies to manage their validation processes electronically, the
ValGenesis Validation Lifecycle Management System (VLMS) significantly reduces
the validation cycle time and cost, eliminates potential data integrity issues
in the validation process, enables standardization and enforces consistency and
compliance in the corporate validation process.” said Robert van der Laan, Vice
President of Professional Services at ValGenesis” “ValGenesis VLMS has been
implemented by 10 out of the top 20 global life science companies. We seek to
align our product roadmap with the evolving regulatory landscape to help our
clients to enable and enforce regulatory compliance. We are confident our
partnership with PharmOut will help the ValGenesis VLMS system become the
de-facto standard for paperless validation across the life science companies
based in Australia and New Zealand” he said.

PharmOut looks
forward to working with ValGenesis into the future and supporting their
expansion into Australia.

You can find
out more about each company and the solutions they provide on the
ValGenesis and PharmOut websites.

About PharmOut

PharmOut is an international consultancy
founded in 2006 which has grown a strong reputation in offering leading GMP
compliance, validation, regulatory, engineering and architectural consulting
services solutions to the 
pharmaceutical and life science industries.

PharmOut holds ISO 9001:2015 certification
from 
LQRA and our Quality Management System is certified to the ISO
9001:2015 standard for the provision of 
engineering, architectural design and consultancy services.

 

About
ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform
serving as the foundation for managing compliance-based validation activities
in Life Sciences companies. ValGenesis, Inc. provides the first enterprise
application to manage the corporate validation lifecycle process. As the only
system for managing validation execution and approval 100% electronically,
ValGenesis was selected by an industry peer review committee to receive the
Parenteral Drug Association (PDA) New Innovative Technology Award. The solution
is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. For
more information, visit ValGenesis’website at 
https://ift.tt/KIvRBS

Source link

Tuesday, May 1, 2018

New partnership supports customers in implementation of serialisation solutions

A new partnership has been formed between Mettler Toledo PCE (product inspection specialists) and R-Pharm Germany (contract manufacturer) to support pharma customers in the implementation of serialisation and aggregation solutions.

Through this collaboration, customers will be able to experience Track & Trace systems first hand in a live production facility, enabling them to understand the available options and develop solutions to meet their specific requirements more effectively.

The implementation, or upgrading, of serialisation systems is becoming more pressing as compliance with the Falsified Medicines Directive (FMD) bears down — coming into effect in February 2019.

In addition to helping customers develop their own Track & Trace solutions, the R-Pharm facility — equipped with Mettler Toledo PCE technology — can also provide a bridging service for pharmaceutical customers until their own plant is upgraded.

“Our clients expect from us a direct connection to their own ERP or MES systems, or would like to use serial numbers of cloud systems such as Tracelink,” said Michael Unbehaun, engineering manager at R-Pharm. “Therefore, we make sure that our software systems are always state of the art and successively expand the interface palette. In this way, we can ensure efficient and rapid on-boarding of new clients and enable them to exploit the potential of our lines.”

The companies have also started to offer combined workshops to provide a more intensive discussion of selected topics, from line integration and its process organisation to data exchange with cloud providers. For those looking to delve deeper, subject-specific training will be offered via a new T&T User Academy, including sessions on topics ranging from the development of so-called SOPs (Standard Operating Procedures) to pharmaceutical validation of machines or OEE management tactics.



Source link

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

Source link