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 collection, 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.

Advancing Contamination Investigations Through Microbial Intelligence

Microbial contamination investigations are only as effective as the information used to guide them. While a structured investigation approach is essential, accurate microbial identification provides critical insights that help bridge the gap between the detection of a contaminant and the determination of its source.

This presentation explores how microbial identification supports both rapid confirmation of contamination events and deeper root cause analyses by revealing key characteristics of the organism of interest. By transforming a microbial ID into microbial intelligence, organizations can strengthen investigations and make more informed decisions. Attendees will learn how advanced microbial identification technologies, access to extensive microbial libraries, and the development of comprehensive organism profiles can uncover contamination patterns and generate actionable insights that may not be evident from manufacturing data alone.We will also examine the operational, financial, and regulatory consequences of microbial misidentification, including misdirected investigations, delayed remediation efforts, and inaccurate risk assessments. Attendees will leave with a deeper understanding of how accurate microbial identification can transform contamination investigations by uncovering actionable insights that prevent recurrence and strengthen contamination control programs

Presented by Doug Botkin, PhD, 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

For more than 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines but set a new standard in the way you perform testing. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant, and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers manufacturing costs, and helps protect your reputation.