Various bevacizumab products are currently approved for use in the clinical setting, with many others currently under clinical development across the world. To aid the harmonization of potency assessment across the bevacizumab products, our leading scientists at the NIBSC have worked collaboratively with the World Health Organization (WHO) to develop an international standard (IS) for bevacizumab.
We conducted an international collaborative study to compare the relative potencies across the different assays. Variability in relative potency estimates was reduced when the candidate standard was used for bioactivity assessment compared with various in-house reference standards, enabling harmonization in bioactivity evaluation. Our bevacizumab IS standard, coded 18/210, established by the WHO Expert Committee on Biological Standardization, is intended to support the calibration of manufacturer’s in-house standards for product development and lifecycle management as well as other secondary standards (regional, pharmacopoieal).
Our bevacizumab IS 18/210 is now available for use and will help support the harmonization of bioactivity to ensure patients access safe and efficacious bevacizumab products.
Dr Haiyan Jia, Head of Growth Factors in the Division of Biotherapeutics at the NIBSC, comments:
"With our focus on delivering for patients, we hope to continually develop new standards for the diverse range of anti-vascular endothelial growth factor (VEGF) biological medicines. The outputs of these standardisation projects will help to harmonise bioactivity and support the development of more cost-efficient biosimilar products for increasing patient access to safe and effective VEGF-targeted therapies globally.”
Read full article: Biomolecules | Free Full-Text | The First WHO International Standard for Harmonizing the Biological Activity of Bevacizumab | HTML (mdpi.com)
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Order now our Bevacizumab International Standard (NIBSC product code: 18/210).
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