Microbiological Attributes, Specifications and Risk Assessment of Culture-based Therapeutic Products

24th March 2021 | 10:00am EST | Tony Cundell, PHD. Principal Consultant, Microbiological Consulting, LLC, |BOOK FREE SEAT FOR THIS WEBINAR

A major challenge with emerging heterogeneous, live culture-based products is setting consistent, risk-based microbial specifications to protect the recipients of these product from potential microbial infection. A review of the literature and the published regulatory requirements demonstrates a lack of consensus as to donor and/or product infectious disease screening that may inevitably harm patients along with increased costs and delayed product availability. This presentation addresses the microbiological attributes, specifications, screening methods, and risk assessment of these unique products that contain live microbiological cultures, include probiotics, fecal microbiota transplantations, fecal-derived consortium cultures and therapeutic bacteriophage products and makes recommendations as to the path forward.

Presented by Tony Cundell, PHD. Principal Consultant, Microbiological Consulting, LLC,

Dr. Tony Cundell consults with pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories, as a Senior Principal Scientist in early phase drug development. Earlier in his career, he worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

He is a member of the 2020-2025 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods.

Tony Cundell chaired the PDA task force responsible for the 2000 Technical Report No. 33 The Development, Validation, and Implementation of New (Rapid) Microbiological Methods. In 2009, he co-edited the book Water Activity Applications in the Pharmaceutical Industry and contributed two chapters. He was co-chair of the PDA task force responsible for the 2014 Technical Report No. 67 Exclusion of Objectionable Microorganisms from Non-Sterile Drug Products. He received the 2016 PDA Martin Van Trieste Pharmaceutical Science Award for outstanding contributions to pharmaceutical science.

Recently Tony Cundell co-authored Controls To Minimize Disruption of the Pharmaceutical Supply Chain During the Covid-19 Pandemic published in the July-August, 2020 issue of the PDA J. Pharm. Sci. & Technol.


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