Roundtable Discussion: Sterility Testing Challenges and Opportunities for ATMPs

ATMPs, especially short-life ATMPs, may present unique challenges as it relates to when, where, and the most appropriate type of testing to perform. 

The roundtable will provide an insight into the below topics:

•             Various rapid testing methods

•             Establishing the most appropriate steps in the process to perform testing

•             Determination of sample sizes

•             Overcoming regulatory challenges

•             Method validation

•             Sample Storage

•             Aligning testing strategy with the Contamination Control Strategy

The panellist include

Dr David Roesti, PhD. Microbiology Expert/Senior Technical Steward Manufacturing Science and Technology at Novartis Pharma AG

Dr. David Roesti holds a PhD in microbial ecology from the University of Neuchâtel, Switzerland and has more than 25 years of experience in the field of microbiology. Currently he works at Novartis Pharma AG in Stein Switzerland in the Manufacturing Science & Technology department and is responsible to define the microbial control strategy at the site and is a global subject matter expert in microbiology for the Novartis group. Prior to this assignment, he led the Rapid Microbiological Methods team at Novartis Pharma AG and was the laboratory supervisor for the microbiological testing of non-sterile drug products at Novartis Pharma Stein AG. David Roesti is an elected member of the General Chapters Microbiology Expert Committee of the United States Pharmacopoeia 2025-2030 revision cycle and is a member of the advisory board of the European Compliance Academy Microbiology Group. Finally, David Roesti is main author or co-author of many different publications in either peer-reviewed journals or book chapters and has regularly held presentations in scientific congresses or expert groups.

Irving Ford, VP of Quality & Compliance at Made Scientific

Irving Ford, is a Quality Executive. He is a proven executive leader with over 29 years of Quality experience in pharmaceutical/biotechnology and cell/gene therapy industries. Irving has successfully contributed to the approval of four (4) commercial ATMP products to date. Irving is an active member of PDA and the PDA ATMP Advisory Board.  Irving’s co-authored PDA’s ATMP Points to Consider document and the published White Paper – Risk Assessment Approach to Microbiological Controls of Cellular Therapies and has also contributed to numerous PDA Technical Reports.

Friedrich von Wintzingerode, Director, ADQC Microbiological Sciences at Roche-Genentech

Friedrich is Director, ADQC Microbiological Sciences at Roche-Genentech. His team ensures the safety of critical materials, drug substance, and drug product for cell therapies and individualized therapies by focusing on adventitious agents control (viruses, parasites, mycoplasma, bacteria, and fungi). Friedrich joined Roche-Genentech after earning his PhD in Microbiology and has over 24 years of experience in Quality Control and Quality Assurance in the biopharmaceutical industry, working on various topics including microbiological testing, material qualification and specifications, environmental monitoring, cleaning analytics, and analytics for release. Friedrich has led several global technical teams (e.g. microbial identification, microbiological testing for ATMPs, endotoxin testing, Low Endotoxin Recovery/LER, and ATMP materials) at Roche-Genentech and PDA. Friedrich is chair of the PDA ATMP advisory board and co-chair of the 2025 – 2030 USP Microbiology Expert Committee.

 Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca

Sophie Drinkwater is an associate director in microbiology at AstraZeneca, working in the Global Product Development group. Sophie has worked in pharmaceutical microbiology for 9 years in both GMP quality control laboratories and pharmaceutical development. In her current role, alongside developing control strategies and regulatory authoring, Sophie is focused on the feasibility testing and implementation of rapid technology in the microbiology space. Sophie is also an active member of several industry consortiums involved in developing new technology solutions as well as global pharmaceutical microbiological strategy.  

Brian Conti, Product & Commercial Leader at Rapid Micro Biosystems

Brian has been with RMB for 6+ years holding progressive roles in Product Management. He currently leads the commercialization of Growth Direct Rapid Sterility as a new innovative solution to rapid sterility testing, building upon the widely adopted Growth Direct platform

Dr. Joseph Pierquin, Founder and CTO of Redberry, part of Lonza

Dr. Joseph Pierquin is the Founder and CTO of Redberry, now part of Lonza, where he focuses on developing and implementing rapid microbiological solutions for pharmaceutical applications. He is a graduate of École Normale Supérieure (Cachan) and holds a PhD from the University of Lille, France. With nearly 20 years of experience in rapid microbiological methods, he has advanced microbial detection technologies supporting quality control and contamination control in regulated environments. Before founding Redberry, he held leadership roles at Merck Millipore and bioMérieux. At Merck Millipore, he led product development within the Biomonitoring Business Unit, concentrating on rapid systems for bioburden and sterility testing. He later founded Advencis, developer of a growth‑based rapid microbiology method acquired by bioMérieux. His expertise includes alternative sterility testing approaches such as Solid‑Phase Cytometry and advanced optical detection systems, supporting the integration of rapid methods into GMP workflows for time‑sensitive products including ATMPs.

Stephane Dubreux, Pharm.D. / MBA, Scientific Affairs Director for Pharma Quality Control at bioMérieux

Stéphane DUBREUX, Pharm D. / MBA is leading the scientific affairs team within the Pharma quality control franchise at bioMérieux. He completed his Pharmacy degree and internship in Lyon’s university and its main public hospital: Hospices civiles de Lyon. He integrated bioMérieux in 1999 and took over several positions in QA/QC, R&D and scientific affairs for clinical, veterinary and Pharma quality control diagnostic markets. He has always been around innovation management and has an extensive experience in rapid microbiology methods. His main driver is to put all his energy and experience to benefit to the vein to vein time for Cell and gene therapy patients and a better patient outcome.

Sponsored by Rapid Micro Biosystems, Lonza and bioMérieux