Regulatory Challenges of Recent Low Endotoxin Recovery Regulatory Queries - Seguridad Mania.com - España y América Latina

Full title: Regulatory Challenges of Recent Low Endotoxin Recovery Regulatory Queries: Pfizer’s Strategy to Evaluate and Implement Global Changes to Meet Evolving Expectations The frequency and scope of inquiries related to Low Endotoxin Recovery (LER) from health authorities for biotherapeutic product submissions have dramatically increased over the past year. LER studies are required by the Center of Drug Evaluation and Research (CDER) – Food and Drug Administration (FDA). The Parenteral Drug association (PDA) Technical Report (TR) No. 82, Low Endotoxin Recovery, is used as a guidance for performing LER studies for Biologics License Application (BLA) submissions to CDER, although some recent queries diverge from PDA TR 82. In September 2023, the European Medicines Agency (EMA) published Questions and Answers on biological medicinal products, containing the question, “When should Low Endotoxin Recovery (LER, also known as “endotoxin masking) be investigated?”. The provided answer to this question does not specifically define LER or offer detailed instructions on study methodologies. Due to the increase in queries, an assessment of the queries in a trackable database was completed. This presentation will highlight the major themes observed in these queries, particularly those that had tangible impacts on our LER strategy.