Session Details

Rapid microbiological methods in meeting unique QC needs of advanced therapy manufacturing (Corporate Tutorial Hosted by Roche CustomBiotech)
Saturday, September 14, 2019 12:30 PM - 01:30 PM
Ballroom A
Rapid microbiological methods in meeting unique QC needs of advanced therapy manufacturing

Rapid microbiological methods (RMMs) are essential for state-of-the-art manufacturing efficiency of advanced therapies because traditional testing methods do not provide shorter testing timelines and lower sample volume utilization.  Some advanced therapies involve a manufacturing process and release timeline of just a few days making third-party testing impractical.  There are ways to incorporate RMMs for QC testing, such as using a nucleic acid amplification technique as an alternative mycoplasma testing system after appropriate product-specific validation in-house.  Leveraging available validation data facilitates a regulatory abbreviated qualification plan for RMMs.  Uncertainty around vendor selection, method qualification, and costs associated with RMM implementation often impede advanced therapy manufacturers from adopting these RMMs for QC testing.  This session is intended to clarify uncertainty on the facts and related issues on implementing rapid microbiological methods by providing accurate information and real-world experience.

Chair: Evonne R. Fearnot, MSBME, Marketing Manager, Roche CustomBiotech, USA

Speakers:

Sowmya Viswanathan, PhD,
Affiliate Scientist, Krembil Research Institute, University Health Network, Canada
Assistant Professor, Institute of Biomaterials and Biomedical Engineering, University of Toronto, Canada
Assistant Professor, Department of Medicine, University of Toronto, Canada
Regulatory and Manufacturing Advisor, OIRM, Canada