A Systematic Approach to Responding to Microbial Contamination Events in Biopharmaceutical Manufacturing

Microbial contamination events during biopharmaceutical manufacturing can lead to costly batch failures, regulatory scrutiny, and patient safety risks. Current industry practices often lack standardization, resulting in inconsistent investigations and delayed remediation. This presentation introduces a comprehensive, industry-driven framework developed by the BioPhorum Microbial Control workstream to standardize contamination investigations. The approach builds on PDA Technical Reports (TRs 69, 88, and 90) and EU GMP Annexes 1 and 2, offering a practical two-phase process: • Phase 1: Rapid confirmation of contamination, laboratory investigation. • Phase 2: Detailed investigation leveraging multidisciplinary teams, Gemba Walks, structured evidence collectio n, and robust root cause analysis tools (5 Whys, Fishbone, FMEA).

Presented by Hilary Chan, Global Sterility Assurance and Microbiology Lead at Takeda

Hilary Chan, M.S. is a Global Sterility Assurance and Microbiology Lead at Takeda where she is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations.  She is a global business process owner and community of practice network lead for microbiology, sterility assurance, and contamination control related topics.  She is an invited speaker at industry conferences, has authored various scientific publications, and is active in industry collaborations. Hilary has 26 years of experience in the pharma/biotech industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.

Followed by Doug Botkin, Scientific Portfolio Specialist at Charles River Laboratories

Dr. Doug Botkin is a Scientific Portfolio Specialist with Charles River Laboratories. He is a subject matter expert in the Microbial Solutions group and enjoys helping customers find solutions to their microbial control challenges. Doug has over 25 years of experience in infectious disease research, spaceflight microbiology, and pharmaceutical microbiology, including working in QC microbiology groups at 503B outsourcing, cell and gene therapy, and non-sterile manufacturing sites. He holds a bachelor’s degree in Biological Sciences from Illinois State University and earned his PhD in Microbiology and Molecular Genetics from The University of Texas Health Science Center at Houston.

Followed by a live question and answer session

Sponsored by Charles River Laboratories