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
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
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
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