With its extensive experience and successful track record (250+ GMP viral vector batches manufactured and 20+ clinical and commercial programs), AGC Biologics is one of the world leaders in GMP production of retroviral and lentiviral vectors.
We manufacture viral vectors in multiple scales, enabling us to meet all of our customers’ needs for both clinical and commercial use.
- Proprietary packaging plasmids and producer cell lines for vector manufacturing
Process development and analytical methods development
- Process optimization, scale up and automation of viral vector manufacturing processes
- Development, validation and qualification of product-specific analytical methods
- 48L and 200L production scale for retroviral and lentiviral vector manufacturing
- GMP master and working cell banks
- Over 100 in-house vector tests reduce costs and save time (e.g., safety, potency, identity, purity, chemical and physical characterization)
QA and regulatory support
- Quality management systems are aligned with EU ATMP GMP and FDA guidelines
- Support with regulatory agencies