Oct
24
2019
On demand

Rapid mycoplasma PCR QC testing for cell and gene therapies

Rapid microbiological methods (RMMs) are essential for state-of-the-art manufacturing efficiency of cell and gene therapies because traditional testing methods do not provide shorter testing timelines and lower sample volume utilization. Some cell and gene 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. Uncertainty around supplier selection, method validation, and costs associated with RMM implementation impede cell and gene therapy manufacturers from adopting these RMMs for QC testing. This webinar provide insight on the related issues around implementing a rapid mycoplasma PCR QC test in cell and gene therapy manufacturing to help push innovative rapid microbiological methods forward in a field that uniquely needs them.

  • Review roles and responsibilities of suppliers, cell and gene therapy manufacturers, and regulators
  • Discuss the value of using risk assessments for selecting a suitable commercially available rapid mycoplasma test for cell and gene therapy products
  • Share relevant regulatory resources on using rapid PCR mycoplasma test as an alternative to a traditional testing method
  • Case study presentation on Roche MycoTOOL Mycoplasma Real-Time PCR Kit for cell therapy QC

Renate Rosengarten
Professor and Chair of Bacteriology & Hygiene at University of Veterinary Medicine Vienna
Angeliki Grammenos
Manager, Regulatory Affairs at Celyad SA



MycoTOOL Mycoplasma Real-Time PCR and QC Sample Preparation kits are for use in quality control / manufacturing process only.
MYCOTOOL is a trademark of Roche. Other brands or product names are trademarks of their respective holders.

SPEAKERS

Renate Rosengarten
Professor and Chair of Bacteriology & Hygiene at University of Veterinary Medicine Vienna
Angeliki Grammenos
Manager, Regulatory Affairs at Celyad SA

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