Charles River Lab’s Bioassay team contributes to WHO international reference standard for Trastuzumab
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Charles River Contributes to Release of the First WHO International Reference Standard for Trastuzumab

The Charles River Bioassay team contributed to a round robin study to release the first World Health Organization international reference standard for Trastuzumab in 2020. It’s the third time the team participated to establish WHO international reference standards for therapeutic antibodies. In 2017 and 2019 the first international reference standards for Infliximab and Adalimumab were released.

The number of available international reference standards for therapeutic antibodies is still quite low. Therefore, releasing more international reference standards for bioactivity testing of therapeutic antibodies to the market after thorough testing and evaluation of data is a huge step towards a better support of bioassay characterization, calibration, and validation by different stakeholders and also to define international units of bioactivity.

View of autopipetting in microtiter plate

Regulatory Requirements for Bioactivity Testing

Understanding these requirements reduces the chance of rework, delays, and avoid hindering regulatory approvals. Charles River can support bioactivity testing for a range of molecule types.
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Reference standards are crucial for bioactivity testing of therapeutic drugs as described in USP, EP, and ICH Q6B. Where an international or national standard is available and appropriate, in-house reference materials shall be calibrated against it. Learn how Charles River can help you with your bioassay studies.

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