Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins

14th May 2020 | 10:00 am EST | Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca & Piet Christieans, PhD, Scientific Director at Nelson Lab |WATCH FOR FREE

Biologics and Peptides often present their own challenges in respect to leachables. They are typically administered parenterally and therefore there is a high risk of interaction between dosage form and packaging / administration system. They are often low dose and sensitive to structural modifications, this can impact Safety (immunogenicity), Quality (instability, aggregation) and Efficacy (loss of potency). This webinar will examine the potential risk factors through case study examples including reactive leachables, the impact of sterilisation and adverse events and their route cause. It will conclude by looking at opportunities to look predictively at potential issues and how this can be incorporated into product design

Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca

Andrew Teasdale is Chair of AstraZeneca impurities advisory group. Responsible for the development and oversight of policy relating to all impurity categories, including impurity qualification / genotoxic impurities / metals and extractables & leachables. Dr Teasdale is an expert within the field of Genotoxic Impurities as well as the editor of the first book specifically focused on the subject matter : Genotoxic Impurities: Strategies for Identification and Control. His current activities include leading a cross industry group in the development of an addendum table to ICH M7, including specific limits for genotoxic reagents (analogous to that in place in ICH Q3C for solvents). Inventor of the purge factor calculation concept used in the risk assessment of genotoxic impurities. He is currently the chair of the Extractables and leachables safety information exchange (ELSIE) materials group. He is also Chair of the Joint Pharmaceutical Analytical Group (JPAG). His expertise also within quality assurance and pharmaceutical analysis field. With extensive project management experience both internally and in relation to cross industry collaborations. With specialties in Evaluation and risk assessment of genotoxic impurities / metals and extractables and leachables. He has more than 15yrs experience as an analytical chemist and is Chairman of the Joint Pharmaceutical Analytical Group (JPAG).

Followed by Piet Christieans, PhD, Scientific Director at Nelson Labs

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two CROs.

From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas (US), working on hydrogenated triblock co-polymers.

Since 2001, Piet has held the position of Scientific Director at Nelson Labs Europe where he develops analytical methods and protocols for both extractables and leachables studies for the pharmaceutical and medical industries.

Piet oversees all laboratory operations at Nelson Labs Europe and is also giving support to business development and R&D.

Sponsored by Nelson Labs

Nelson 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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