Viral and gene therapy manufacturing site at Carlsbad
- 20 years of experience
- 500 batches of virus to support gene therapy
- single use bioreactor and purification
- phase III and commercial launch (PPQ batch)
- Experience (batches) 2010-2017
- Adeno-associated virus : 19%
- Adenovirus : 20%
- Lentivirus/Retrovirus : 40%
- Reovirus : 5%
- Others : 16%
- in-house process development
- USP : adherent or suspension culture
- DSP
- Technical Transfer
- full tech transfer team for cGMP
- >20 program
- Cell and Viral Banking
- master and working
- cell and viral (access to additional storage in Rockville, Maryland, USA and Glasgow Scotland, UK)
- viral seed stock characterization
- Sterile Fill Finish
- most critical processes in safegarding the sterility
- delivering drug substances intended for use in patient
- 2,000 vials/day in two dedicated Class 1000(ISO 6) fill suites, one of which is designed for commercial fills
- Viral Vector Testing
- Millipore Sigma has a deep understanding on regulatory expectations of safety evaluations of viral vectors
- BioReliance biosafety testing services into our workflow
- Viral vector characterization and testing
- Secure Biostorage
- freezers of -80℃ and -20℃
- liquid nitrogen dewars
- Leader in Viral Vector Mnufacturing
- SAFC Carlsbad
- >20 years of track record in developing and manufacturing viral vectors and vaccines from 1990s
- In 2017 expansion
Bio Reliance (Carlsbad), サンディエゴ、US