Monoclonal Antibodies
Pembrolizumab
Mammalian Cell Culture – mAb
A humanized IgG4 monoclonal antibody targeting PD-1 (Programmed Cell Death Protein 1), with landmark approvals across immuno-oncology for multiple solid tumors.
Technical Specifications
Expression Host
Chinese Hamster Ovary (CHO-K1 / CHO-S)
Finished Formulation
Concentrate for solution for IV infusion
Development Scope & Deliverables
- High-producing CHO cell line development & feed optimization
- Protein A affinity capture, viral inactivation & polishing chromatography
- Full biosimilarity physicochemical & functional characterization
- Regulatory CMC dossier preparation & single-use bioreactor scale-up
Licensing & Tech Transfer
Request full CMC packages, analytical method validation reports, and technology transfer dossiers.
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