カテゴリー
AAV BIOLOGICS CMO company

気になる企業 – BioReliance/Carlsbad – CDMO of AAV gene therapy – ID3754 [2020/06/18]

気になる企業 – BioReliance/Carlsbad – CDMO of AAV gene therapy – ID3754 [2020/06/18]

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
  • 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

用語の解説、関連タグ付き投稿の抽出

Bioreliance

[Bio-rAAV] 遺伝⼦治療における代表的な委託製造会社 (CMO) – △ID1881 [2021/02/08]

Carlsbad

スポンサーリンク ID 7130582967

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