気になる企業 – Creative Biolabs Inc. はcGMP製造もできるCRO – ID2413 [2020/05/21] ID2413

Creative BioLabs

Creative BioLabs Incはアメリカに本社を置き.イギリスとドイツにも拠点を持つ.

前身は2006に設立、2015年にfoundされました。創薬初期のステージで使用する技術としてPhage display,ハイブリドーマ作成などの実施が可能である.カスタムバイオテクノロジーと製薬サービスを提供する.創薬後期のステージで使用するヒト化技術,親和性成熟技術など,高度な分析技術を必要とするサービスも提供できる.を作製できる抗体は,研究用,診断用,治療用の提供が可能.cGMPによるモノクローナル抗体製造は1,000L規模で可能.100名の擁するContract Research Organization (CRO)です.。format変換, identification, affinity maturation, humanizationなどresearch段階での技術は高く、できることは沢山の説明はあります。

https://www.creative-biolabs.com/immuno-oncology/cell-culture-process-development.htm

Comprehensive service portfolio including antibody

  • reformatting
    • Fab
    • F(ab)’2
    • scFv
    • VHH
    • minibodies
    • bispecific
  • production
  • epitope binning and mapping
    • identify the epitope
    • elucidate the mechanism
    • strengthen intellectual property
  • humanization
    • variety of methods and toolkits
  • affinity maturation
    • high-throughput phage library
  • affinity measurement
    • kinetic properties
  • sequence liability identification
  • immunogenicity prediction
    • in vitro screening (Sensitive immunogenicity Assessment Technology; SIAT)
    • in vivo screening

cGMP manufacturing

Development

  • Culture media screening and adaptation
  • Material preparation for different stages of projects, such as transient and pool material production
  • Various bioreactors available
  • Productivity and/or quality optimization
  • 細胞培養プロセス開発
    • クローン選択から培養条件の最適化
    • 培養開発プラットフォーム
    • 100名以上の専門スタッフ
  • 1L~2,000L cGMP製造
    • Wave
    • Vi-cell
    • YSI
    • Cedex Bio HT
    • Novaflex
    • Bioprofile 400
    • BGA
    • Terumo tubing welder
    • Osmometer
    • Steril tubing
    • welder and sealer
    • Integrity tester
    • Media prep systems for lab & pilot plant

Product Quality Optimization

  • Aggregation control
  • Charge variant control
  • Glycosylation optimization
  • Sialic acid content optimization
  • ADCC/CDC activity optimization

Late stage cell culture process development

  • Technical transfer
  • Commercial process development service
  • Process characterization and validation

IND-enabling cell culture activities

  • Clone selection and process optimization
  • Scale-up and toxicological material production
  • Technical transfer for cGMP production for worldwide IND submissions

Perfusion and concentrated fed-batch platform

  • High viable cell density and viability
  • For perfusion: long term steady-state operation and stable productivity and quality
  • For concentrated fed-batch: quick adoption from fed-batch with high harvest product titer and improved quality
  • From bench top scale-down model to cGMP anufacturing production

GENE THERAPY DEVELOPMENT

Adeno-associated Virus Vector

様々なHost Cellを提供している

YB2 / 0細胞株 : フコース含有率が低いラット骨髄腫細胞株

rcAAVの測定

委託で測定を受けてくれる。

Replication-component AAV testing

Replication-incompetent vector particles derived from AAV (adeno-associated virus) have been shown to mediate transfer and expression of heterologous genes (transgenes) into a variety of cells in vivo and in vitro. It has tremendous potential in both research and therapeutic applications.

https://www.creative-biogene.com/Services/Custom-Viral-Service/Replication-Competent-AAV-Testing.html
編集履歴
2019/09/26 はりきり(Mr)
2020/05/21 追記(詳細サービス)
2020/11/24 追記(rcAAV測定)

以上