Trastuzumab

: A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (called 'reference medicine') in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Trastuzumab is a biosimilar monoclonal antibody specifically designed to target cancers that are HER2 positive. By binding to the HER2 receptor, Trastuzumab can slow down cell replication, making it a targeted cancer drug. It is commonly used in the treatment of early and advanced breast cancer, advanced stomach cancer, and cancer of the gastro oesophageal junction.

CHO suspension cell line adapted to high-density culture (>20x10^6 c/ml), and with rapid growth in serum-free media.
Production process of 12 days and 1200 mg/L of Trastuzumab. Final pure Trastuzumab yield is 1000 mg/L.
Optimization of both light and heavy chains promoter and terminator
Optimisation of signal peptides
QC according to USP Medicines Compendium

End-to-end process for the production of monoclonal antibody Trastuzumab in mammalian CHO suspension cell line adapted to high-density culture (>20x10^6 c/ml), and with rapid growth in serum-free media. The quality of the product satisfies European Pharmacopoeia requirements.
Trastuzumab is a recombinant humanized IgG1 monoclonal antibody that binds with high affinity and specificity to extracellular domain of HER2.
It is an essential medicine for early stage breast cancer and metastatic cancers.
Globally, breast cancer is the most common cancer for women in both developing and developed countries, and the leading cause of cancer death for women.
17-30% of breast cancers have a HER2-positive phenotype
HER2-positive tumors are more aggressive and less responsive to standard chemotherapy than HER2- negative tumors.

Trastuzumab is used for treating HER2 positive breast cancer and other aggressive epithelial cancers (stomach and gastro-oesophageal junction)