Webinar at the Cell Therapy Manufacturing & Gene Therapy Congress for Europe, March 27, 2017
Webinar at the Cell Therapy Manufacturing & Gene Therapy Congress for USA, June 6, 2017
THE CAP®GT EXPRESSION SYSTEM:
FULLY SCALABLE PRODUCTION OF GENE THERAPY VECTORS IN A HUMAN SUSPENSION CELL LINE
Webinar Attendees Will Learn About:
- Growth characteristics of CAP®GT cells and their performance with respect to AV, AAV and LV production
- An optimization approach to maximize transient production of lentiviral vectors
- CAP®GT cells as a platform to generate stable packaging and producer cell lines
About the Webinar:
A rapid increase in the number of gene therapy trials and products has led to a comparable increase in the need for industrial production of viral gene therapy vectors such as lentiviral, adeno-associated, and adenoviral vectors.
Current vector production systems rely on human embryonic kidney cells, often grown in adherent cultures or on insect cells. Both systems are successfully employed but face challenges with respect to scalability and robustness.
CEVEC has developed fully characterized human cell lines, which have been optimized for industrial use. These CAP®GT cell lines grow in single cell suspension up to very high cell densities and are fully adapted to serum-free growth in animal component-free chemically defined media. The cells have been completely documented from the initial derivation of human primary cells up to GMP master cell banking. A Biologics Master File for CAP®Technology (BB-MF) has been submitted to the U.S. FDA and is referenceable for CAP® Technology Licensees, simplifying regulatory approval processes for CAP®derived products .
CAP®GT cells very efficiently produce adenoviral, AAV or lentiviral vectors and thus present a fully scalable platform for the production of gene therapy vectors being compliant with regulatory requirements.