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

Creative BioLabs

目次

1. Creative BioLabs
2. Comprehensive service portfolio including antibody
3. cGMP manufacturing
4. Development
5. Product Quality Optimization
6. Late stage cell culture process development
7. IND-enabling cell culture activities
8. Perfusion and concentrated fed-batch platform（2ページ）
9. 様々なHost Cellを提供している（2ページ）
10. rcAAVの測定（2ページ）

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

• https://www.creative-biolabs.com/immuno-oncology/cgmp-manufacturing.htm
• microbial
• mammalian
• plasmid DNA production and purity
• Advanced packaging/filling equipment
• All the upstream and upstream processes use a single system
• FDA’s formal regulations on the design, monitoring, control and maintenance
• Code of Federal Regulations (CFR) is the compilation (21)

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