Rapid Micro Methods for ATMPs and Other Biologics
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PDA Midwest and Southeast Chapters invite you to learn about four specific Rapid Microbiological Methods available in the biologics space, with the help and background of an industry panel of experts!
The term ATMP includes short-shelf-life drugs and therapies with a biologically-sourced Active Pharmaceutical Ingredient (API) that is either a recombinant nucleic acid or cells. These include stem cells, Car-T cells, Gene therapies, mRNA therapies, and more. This CUTTING EDGE research may hold the keys to curing cancers, neurological disorders, birth defects, orphan diseases, and yes, even a Pandemic.
The emergence of these REVOLUTIONARY therapies comes with a significant challenge: ensuring they are free of contamination as quickly as possible due to their short shelf lives. As they are often administered within hours of preparation, there is a significant patient safety risk to using traditional methods relying on 14 or more days of incubation of used to test for sterility and up to a week for bioburden results.
Rapid microbiological methods (RMMs) provide a viable solution for this challenge by detecting contamination sooner and reducing patient safety risks.
Presentation Date and Time:
Tuesday, November 16, 2021 @ 10:30 am (central time zone)
Irving Ford, Head of Quality, Cell Therapy Manufacturing Facility at Bristol Myers Squibb.
Biswarup DasGupta, Director, Quality Assurance, Gene Therapy at Sarepta Therapeutics.
Mary Miller, Quality Control Microbiologist, Novartis Gene Therapies
|Opening, Panel Introductions, Current State||10:30m – 10:40am*|
|Using ATP Bioluminescence for Detection of Microbial Contamination in T-Cells with Celsis Adapt™
Speaker – Stacey Ramsey, Senior Manager, Celsis Technical Services and Validations at Charles River Laboratories
Additional Charles River representative: Jon Kallay, Senior Technology and Market Development Manager at Charles River Laboratories
|10:40am – 11:20am*|
|Panel Responses, Questions||11:20am – 11:30am*|
|Overview of Growth Direct ® Rapid EM and bioburden method compatible with short shelf life products
Rapid Micro BioSytems Representatives: David Jones, Director of Industry Affairs
|11:30am – 12:10pm*|
|Panel Responses, Questions||12:10pm – 12:20pm*|
|Evolution of Smart Quality Monitoring Solutions for Testing Cell & Gene Therapy Products
Speaker – Lori Daane, Sr. Director of Scientific Affairs at bioMérieux
|12:20pm – 1:00pm*|
|Q&A Panelists||1:00pm – 1:10pm*|
|Q&A From Audience to Presenters and/or Panelists||1:10pm – 1:30pm*|
|*Central time zone|
Thanks to our sponsor, general admission is FREE
The Midwest and Southeast Chapters of the PDA is very grateful to our dedicated members and sponsors for their continued interest, participation and support. We truly appreciate the generosity of our sponsors over the years, for without you, we could not provide this level of activity for our members.
- 2 minute pre-recorded commercial video during the webinar
- Recognition in email/social media correspondence of webinar