There is currently no agreement on a format for a leachable risk assessment approach when applied to a biopharmaceutical manufacturing system. USP and Biophorum have published some guidelines; however, both guidelines have (in the opinion of this speaker) some gaps and flaws. This webinar will provide a review of the USP and Biophorum guidance and suggest an alternative approach that seeks to address these gaps. The approach provides both a consideration of leachable risk in terms of both severity of harm and probability of harm and its associated uncertainty as a result of a biopharmaceutical manufacturing process and its effect on patient safety.

The approach outlined borrows heavily from principles outlined in ICH Q9 and has been presented in part through ELSIE’s whitepapers published to their website. Its key recommendations are to establish a process whereby the leachable risk is clearly identified, followed by a scoring of the risk through a risk analysis, and then a risk evaluation against a pre-agreed risk matrix that will output a clear decision on whether further risk control is required and the risk is either accepted or needs reduction. Subsequent study design and requirements are thus based on these principles rather than a pre-stipulated design.

Presented by Jason Creasey, Managing Director at Maven E&L Ltd Managing Director at Maven E&L Ltd

Jason Creasey is a graduate Analytical Chemist. He set up in 2019 as an independent consultant providing advice on the topic of extractables and leachables (E&L), after working for GSK in the area of extractables and leachables since the mid 1990s. Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority in relation to providing support to extractables and leachables. Before setting up Maven E&L Ltd – a specialist consultancy for all things E&L related, he was the director of a team of analytical chemists who were responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities.  He has had the pleasure of commenting on OINDP PQRI guidelines on E&L for GSK and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”. Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He is a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE, and now is now publishing a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), most recently adding an E&L Forum for exchange of ideas. As well to supporting client projects, among recent E&L activity, he is working and commenting on risk-based approaches to E&L requirements that he hopes will form part of an ICH guidance in the not too distant future.

Extractables Testing of Bioprocessing Materials: From Conceptual Theory to Actionable Extractable Study Design – CASE STUDIES Showing the Practical Hurdles when Performing E-studies

Testing is key to assess process materials for release of substances that can potentially affect patient safety, product quality and/or process performance. USP <665> and BPOG standard extraction protocols specify the design parameters for extractables studies, including the extraction solutions, extraction temperature, extraction time and surface-area-to-extract-volume ratio. In this presentation, the practical hurdles when testing process materials at a laboratory scale will be discussed and illustrated with case studies on extractables testing on filters, tubing, process bag systems, etc. 

Presented by Koen Smets, PhD, Senior Expert Extractables and Leachables at Nelson Labs NV

Koen Smets received his Ph.D. in chemistry from the University of Hasselt (Belgium) in 2013. After working as a post-doctoral researcher at the University of Hasselt, he joined Nelson Labs in 2014 as study director Extractables & Leachables. Currently, Koen is working as senior expert E&L with main specialization in testing of single-use process materials.

Sponsored by Nelson Labs

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 4,000 customers across 15 facilities in the United States, Mexico, Asia, and Europe.  We provide our customers with mission-critical testing services, which assess the quality, effectiveness, and end-to-end sterility of products and, ultimately, the impact of the products on patient safety. These services are necessary for our customers’ regulatory approvals, product releases, and ongoing product performance evaluations.  We have over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety, and quality assurance.  Pharmaceutical lab testing services include microbiology, biocompatibility and toxicology assessments, extractables and leachables evaluations of pharmaceutical containers, sterilization validation, sterility assurance, packaging validation and distribution simulation, and facility and process validation.  We also provide expert advisory services to help customers navigate the regulatory requirements applicable throughout their product’s lifecycle. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.