MR.HARIKIRI-INSIGHTS

タグ: Bioreliance

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

    気になる企業 – BioReliance/Carlsbad – CDMO of AAV gene therapy [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

  • [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]

    [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]

    rAAV vectorを製造するCMOリスト

    企業サイトサイト製造サイト特徴関係
    WuXi Advanced TherapiesUS1,000L遺伝子治療医薬品の開発と製造、AAV vector suspension platformWuXi AppTec
    CatalentUS, EU,footprint(400,000ft23)10 cGMP clinical suites, 200L, 400L, 800L, 2 x iCELLis 500, 24 HYPERStack 26/CS10
    10 cGMP Commercial Campus (including fill/finish)    		>バイオ医薬品30年の経験、20クライアント, AAV vector, 60 prgrampOriginal
    BioRelianceRockville, Maryland, USA & IrelandViral/Cell banking to fill finish (2,000 v/day), Secure Biostorageウイルス・クリアランス試験、Carsbadとの遺伝子治療用製品の開発と製造BioRelianceとCarlsbad(20+ years)がサービスする, California,親会社: Millipore-SIGMA-Merck
    Oxford BiomedicaUKUK(1,200m2, SUB 200L, BSL-C3 Lab)遺伝子治療医医薬品、PCL(*1)、Gene TherapySANOFI, GSK, NOVARTIS
    Broucher
    Lonza Pharma & BiotechUSHuston,Portsmouth, Holland, Singapore, Japan(Nikon)バイオロジクス、遺伝子治療医薬品、AAV, HSV, NDV,(Anc-AAV)Original
    NovasepEUバイオロジクス、遺伝子治療医薬品、Adeno, Lenti, HSV, VSV, VEEV2021/01/15 ThermoFisherによる買収
    MolMedEU
    YposKesiFR~500L
    ~200L SUB, 24 x Cell Factory 10    		遺伝子治療医薬品2016, Genenthonからスピンオフ
    TAKARA BIOJP遺伝子治療医薬品
    IDファーマJPiPS, CRISPR-Cas9elixirgen therapeutics
    遺伝子治療研究所 (Gene Therapy Research Institution)JP遺伝子治療医薬品
    vigene biosciences (2012~)Rockville, MarylandCellSTACK; iCELLis, 50~500L bioreactor, HEK293Plasmid製造、小規模AAVから臨床(GMP)まで、AAV、レンチウイルスOriginal (Small company)
    patheonby ThermoFisher
    詳細    		Alachua, FL
    Cambridge, MA
    Lexington, MA
    Plainville, MA,
    US    		50L~2000L
    		Florida Bio (2006~2016), 100 clients, 500 product released14+years, Brammer BioがPatheonに統合
    VIROVEK
    詳細    		Hayward, CA, USSF9/vaculovirus1e13 vg/$3,500 ~ >1e15 vg/$119.900 価格表あり2006~

    https://www.kantei.go.jp/jp/singi/kenkouiryou/genome/advisory_board/dai5/siryou4-2-8.pdf

    Merck Darmstadtは、Millipore (2010), Sigma-Aldrich(2015)を傘下に収めて

    https://ja.wikipedia.org/wiki/メルク_(ドイツ)

    編集履歴

    2020/07/17 Mr.Harikiri
2021/02/08 追記 (ThermoFisherによるnovasepの買収)