Services and Solutions

GCT

Gene & Cell Therapy

About Gene Therapy

Gene therapy is widely used in the treatment of genetic disorders, it's a method which involves the transfer of a normal gene into the target cell to repair the abnormal gene defect through in vivo or in vitro therapeutic modalities.
Currently, gene transfer and expression are commonly performed by adeno-associated virus (AAV), adenovirus (AdV), lentivirus or retrovirus.

BiBo's CDMO services base on AAV platform

Viral vector design, host cell screening
Plasmid (pDNA) construction, scale up and production (GMP and non-GMP)
Upstream and downstream platform process development and tech transfer
GMP production for viral vector: BL2 based production (20L/50L/200L/500L/2000L), supports adherent/suspension dual process platform
Analytical assays development/transfer/confirmation
Process characterization study (PC STUDY)

BiBo's Advantages

One-stop service for pDNA, gene therapy and recombinant AdV/AAV vector production and vaccines from integrated production site
Well established multi-expression platforms (HEK293 & SF9, and microbial fermentation platforms for pDNA production)
Efficient and robust AAV purification platform process
QbD-driven DoE optimization system to enhance and stabilize AAV vector production
Robust quantitative analytical assays for viral vectors
Core team has the experience with 7 preclinical/clinical phase I and II AAV projects as one of the first gene therapy CMC service provider in the world, and our clients including top 10 multinational pharmaceutical companies in the world.

Capacities and Capabilities