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
- 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