Extractables and Leachables Testing Using a Quality Risk Management Approach


09th September 2020 | 10:00 am EST | Dhaval Tapiawala, Principal Scientist at Pfizer and Dr. Dennis Jenke, Principal Consultant for Nelson Labs |BOOK FREE SEAT FOR THIS WEBINAR

• Understanding extractables and leachables for better adoption of single use systems
• Ensuring safety of drug through determining the level of leachables throughout product life cycle
• Case Study of implementation of standardized testing protocol

Presented by Dhaval Tapiawala, Principal Scientist at Pfizer

Dhaval graduated from University of Pune, India with B.E. in Chemical engineering in 1997. He joined University of Louisville in 1998 and completed his M.S. in Chemical engineering in 2000. His research thesis was increasing single cell protein from distillery waste. He has over 18+ years of experience in biotech industry. He has worked in validation group doing process & equipment validation, engineering group to design, technology transfer and CMC filing of therapeutic, blood plasma and vaccine processes. He has both upstream & downstream experience in microbial and cell culture platforms. In 2016, he joined Pfizer as Principal Technology Scientist to design brown-field capital project to technical transfer of commercial vaccine production to Pfizer site. He has vast experience of designing & implementing single use system in mainstream manufacturing and actively involved in BPOG.

Large Volume Parenterals (LVPs): Extractables/Leachables: Challenges when executing an E/L Program

A traditional chemical characterization approach for qualifying Large Volume Parenteral Container/Closure systems from an Extractable/Leachable perspective becomes challenging due to the defining characteristics of this dosage form. The large daily volumes of drug product administered to a patient – volumes which could be as high as a few liters per day – drive the AET down to levels that are analytically challenging, if not impossible to meet. Moreover, the composition of LVP drug products can be sufficiently complex that response interferences are exacerbated.  Thus, the analytical assessment of E/L compounds in LVPs, including discovery, identification and quantitation, will need to be performed at much lower concentration levels, both in the extracts (in extractable studies) as well as in the drug product (leachable studies). This circumstance has implications on the design of the study, the analytical instrumentation and methods used, the processes used to secure the required information, and the subsequent toxicological risk assessment of the discovered, identified and quantified leachables. This presentation will give a helicopter view on all problems one can encounter in a LVP-qualification process, and will then take a deeper dive into how simulation studies for LVP could assist in addressing some of the issues in the study design and subsequent steps of the qualification process.

Presented by Dr. Dennis Jenke, Principal Consultant for Nelson Labs

Dr. Dennis Jenke became Principal Consultant for Nelson Labs Europe in March 2017. In this role, Dr. Jenke supports the customers of Nelson Labs Europe in the discussion of general principles, concepts, tactics, and/or strategy related to chemical characterization and qualification of materials, components, and systems used in these industries. Furthermore, as Principal Consultant, Dr. Jenke can provide Nelson Labs Europe clients with science-based expert insights into the design, justification, interpretation, and regulatory requirements of the related chemical assessment studies and programs.

Dr. Jenke is also the founder of Triad Scientific Solutions LLC, a consultant-based technical service organization that provides the pharmaceutical, cosmetic, food, and related industries with integrated, science-based, and practical solutions to suitability for use challenges for packaging, manufacturing components and systems, and devices. Dr. Jenke was a Distinguished Scientist at Baxter Health Care Corporation for more than three decades where his primary responsibility involved the assessment of material/product compatibility, including extractables and leachables testing. He has published extensively in the areas of analytical chemistry, material/solution compatibility, and extractables and leachables. Dr. Jenke serves as an expert reviewer for numerous pharmaceutical and analytical journals and is a member of several industry groups such as USP, PQRI, AAMI/ISO, and ELSIE.

Sponsored by Nelson LabsNelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.


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