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Curida A.S. sell "Monoclonal Antibodies GMP"

Basic Information

445
20
5
4.2(80)

Trade Type

Sell

Product Name

Monoclonal Antibodies GMP

Manufacturer(s)

Specifications

  • Expression System: Mammalian cell expression, typically CHO cell lines, used for recombinant monoclonal antibody production from early phase through commercial-scale GMP manufacturing.
  • Purity: Monomer purity of at least 95% by size-exclusion HPLC, meeting release specifications for clinical and diagnostic-grade antibodies.
  • Endotoxin Level: Endotoxin content below 0.5 EU/mg of protein, consistent with parenteral-grade biologic release criteria.
  • Certification Standard: Manufactured under GMP compliant with ICH Q7 and applicable FDA/EMA quality guidelines, supporting supply from early-phase clinical trials through commercial export markets including the US.

Documents

GMP
ISO
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