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Bioanalysis >> Biosimilar Testing >> Trastuzumab Assays

Trastuzumab Biosimilar Assays

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 A diverse set of methods to evaluate comparability of both the biosimilar drug and it's clinical performance 

Trastuzumab (Herceptin®) is a humanized recombinant monoclonal antibody that selectively binds to the extracellular domain of the human epidermal growth factor receptor 2, HER2, a transmembrane protein overexpressed in 25-30% of breast cancers. Trastuzumab is used for the treatment of primary breast cancers which overexpress HER2. Herceptin binds with high affinity (kDa 5nM) to tumor cells over expressing HER2 resulting in loss of malignant growth and metastasis. 

Evaluation of the comparability of trastuzumab biosimilars to the innovator drug should follow the guidelines laid out by the FDA and EMA. The analysis should be multifactorial, taking into account both the physicochemical characteristics and clinical performance of the biosimilar compared to the innovator. 

Learn more:  Complimetary recorded webinar 

Case Study: Product Characterization, PK and Immunogenicity Assays for the Development of Biosimilar Trastuzumab 


Eurofins Bioanalytical Services offers a full range of off-the-shelf trastuzumab assays for comparability testing of biosimilars including: 

Clinical Assays

Trastuzumab PK
A Bridging ELISA for the Quantitative Determination of Trastuzumab (Herceptin®) in Human and Mouse Serum

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Trastuzumab ADA
An ELISA for the Detection of Antibodies to Trastuzumab in Human Serum

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Drug Assays

Trastuzumab Characterization
Methods to Determine the Binding of Trastuzumab to Fc receptors and Complement C1q

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Trastuzumab HER2
Methods to Determine the Binding of Trastuzumab to HER2

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Trastuzumab ADCC
A flow cytometry-based antibody-dependent cell-mediated cytotoxicity (ADCC) assay to measure the potency of trastuzumab

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ADA Trasutzumab

Representative curve for sensitivity of trastuzumab ADA in human serum.

Dotted orange line represents assay cut point.

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