タグ: Carlsbad

BioReliance

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