Mycoplasma contamination can have devastating effects on the manufacture of cell and gene therapies, requiring the destruction of production batches and halting of manufacturing processes, and ultimately, in delayed provision of treatments to patients.
Rapid and sensitive tests are necessary for lot release to ensure the absence of mycoplasma contamination. The compendial culture-based method, although highly sensitive, takes 28 days to complete and requires specialised training and reagents as well as extensive lab space.
In contrast, MycoSEQ™ is a PCR-based assay which offers sensitivity comparable to the culture-based method but with much faster delivery, able to provide results within 24 hours. The rapid testing offered by MycoSEQ™ makes it ideal for in-process testing across the complex biomanufacturing workflow as well as for lot release. It is now widely used and accepted by regulatory authorities including U.S. FDA and EMA, and is offered by WuXi Advanced Therapies as part of our testing portfolio.
In this webinar you will learn:
- Regulatory requirements for mycoplasma testing within the cell and gene therapy pipeline
- How WuXi Advanced Therapies applies their experience to support customers with mycoplasma testing
- The benefits of the MycoSEQ™ assay compared with culture-based methods
Sameer Kalghatgi, PhD
Director of Molecular Biology
WuXi Advanced Therapies
Dr. Sameer Kalghatgi is Director of Molecular Biology at WuXi Advanced Therapies, where he is responsible for managing the scientific and technical operations of the Molecular Biology group. To this role, Sameer brings over ten years’ experience of initiating, directing, and executing multimillion-dollar projects through management of cross-functional teams. Prior to WuXi Advanced Therapies, Sameer was the Senior Director at Infinity Biologix where he managed the high-throughput COVID testing CLIA laboratory and helped conduct over 7 million PCR-based tests. Sameer obtained his undergraduate degree in Electrical Engineering from Mumbai, India. He has a PhD in Electrical Engineering from Drexel University in Philadelphia.
Tim Wright is the editor of Contract Pharma magazine, which is a trade publication serving thousands of pharma and biopharma outsourcing professionals. He has been editor at Rodman Media since 2006. Prior to his position at Contract Pharma, he was an editor at Coatings Worldand Nonwovens Industry publications. Tim has a B.A. from Montclair State University in New Jersey where he studied English literature and journalism.
This webinar is hosted by Contract Pharma and you can register here: https://event.on24.com/wcc/r/3823021/31AC84613BB5B25F0ACEA66A68448D68