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Trastuzumab biosimilar API is a biologically derived active pharmaceutical ingredient used in the treatment of certain types of breast cancer and other HER2-positive cancers. It is a monoclonal antibody that targets the HER2 receptor, inhibiting tumor growth and promoting cellular apoptosis. This biosimilar is produced through complex biotechnological processes, including recombinant DNA technology, which ensures that it closely mimics the original trastuzumab molecule in structure and function.
| Form | Lyophilized powder |
| Purity | Typically ≥ 95% |
| Storage conditions | 2°C to 8°C |
| Shelf life | 24 months from the date of manufacture |
| Dosage form | Injection |
When selecting a trastuzumab biosimilar API, buyers should consider the specific grade required for their application, as well as the necessary purity levels and storage conditions. It's important to specify any relevant certifications or compliance with regulatory standards, such as GMP (Good Manufacturing Practices). Additionally, buyers should indicate the required quantities and any specific documentation needed for traceability and quality assurance.
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A biosimilar API is a biologically similar version of an original biologic drug, designed to have similar efficacy and safety.
It is produced using recombinant DNA technology in living cells, ensuring it mimics the original trastuzumab.
Trastuzumab biosimilar should be stored at 2°C to 8°C to maintain stability.
The typical shelf life is 24 months from the date of manufacture.
It is primarily used in oncology, pharmaceutical manufacturing, and biotechnology research.
Purity levels are typically ≥ 95% for trastuzumab biosimilar APIs.