In the 2022 Nelson Labs Virtual Symposium, this presentation will focus on the critical issue of leachables in pharmaceutical products, which can originate from manufacturing items such as filters, bioreactors, and other disposables used in the production process. With the increasing adoption of disposable materials in the pharmaceutical industry, concerns related to Extractables and Leachables (E&L) have significantly intensified.
Biopharma industry groups like the Bio-Process Systems Alliance (BPSA) and the BioPhorum Operations Group (BPOG) have published guidelines on when and how to conduct E&L studies for these materials. Additionally, the United States Pharmacopeia (USP) has released chapters <665> and <1665>, which specifically address E&L for production materials in the biopharmaceutical industry.
This presentation will outline the various steps involved in assessing the E&L impact of a production line. Attendees will gain a comprehensive understanding of the methodologies and best practices for performing E&L studies, ensuring that all potential leachables are identified and managed effectively. The session will also delve into the specific recommendations provided by BPOG and USP, offering practical insights into how these guidelines can be applied in real-world scenarios.
Participants will learn about the importance of E&L studies in maintaining the safety, quality, and efficacy of pharmaceutical products. The presentation will cover the detailed process of conducting these studies, from initial risk assessment to the implementation of appropriate testing protocols and interpretation of results.
By attending this session, professionals involved in pharmaceutical production and quality assurance will be better equipped to handle the complexities of E&L studies, ensuring compliance with industry standards and regulatory expectations. This knowledge is crucial for safeguarding the integrity of pharmaceutical products and protecting patient safety.