Considerations for biosafety testing of cell and gene therapies

Wednesday, March 20, 2024 at 12:40 PM to 1:00 PM · 20 min. (Europe/London)
Cell Therapy Manufacturing [Track 10]
Presentation
SGS Vitrology
60
SSG Vitrology Limited was founded in 2007 and acquired by SGS in May 2012. The site provides safety testing services of biologics, with a strong focus on quality of service and scientific ability. Our team of experienced scientists have over 20+ years experience providing a comprehensive range of GMP, FDA, EP, ICH compliant validated assays. As a world leader in biopharmaceutical testing services, SGS Vitrology offer you a complete range of GLP/GMP biologics safety testing, including virology, cellular and molecular biology, as well as microbiology and electron microscopy. We pay special attention to our customers’ turnaround time requirements and partner that with best in class customer service and communication. As a result, we help you to ensure product safety and meet your regulatory requirements, therefore adding value to your business by providing reliability, high quality & compliant GMP validated assays, scientific expertise, and pro-active communication with direct access to your dedicated project management team and scientists. SGS Vitrology has decades of experience characterizing cell banks and virus seeds used in the manufacture of gene therapy vectors, vaccines, and recombinant proteins. We have worked with clients using a range of cell lines (e.g. CHO, HEK293, Sp2/0, Hi5, Sf9, MDCK, Hybridoma) and viral vectors (e.g. Adeno, AAV, Lentivirus, Vaccinia). A summary of our services are as follows: • Cell Bank and Virus Seed Characterisation per the major compendia, regulatory and ICH guidelines • Raw material and Bulk Harvest testing • Drug Substance and Final Product testing • Custom Development/Validation of assays including new or method transfers

Documents & Links

  • Considerations for biosafety testing of cell and gene therapies

Registered attendees

Andrea Zobel
Andrea Zobel
Senior Director, Personalized Supply ChainWorld Courier
Inge Jedema
Inge Jedema
Head of Translational Cellular TherapyNetherlands Cancer Institute / Antoni van Leeuwenhoek
Isaak Decoene
Isaak Decoene
Postdoctoral researcherKU Leuven

Log in

See all the content and easy-to-use features by logging in or registering!