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CD Formulation will develop personalized proposals to perform the analytical method validation of bioactivity and potency for bio-pharmaceuticals based on the customer's needs.
Biological activity and potency measurement mainly refers to relative potency measurement. This method compares the biological reaction of the test product with the reaction produced by the known standard product, thereby quantitatively determining the potency of the test product relative to the standard product.In the quality control of biological products, bioactivity and potency is the critical quality attributes that reflects the effectiveness of biological products. Therefore, standardized methodological verification of the corresponding measurement methods is a prerequisite to ensure their applicability.
Here are following four steps for analysis method validation procedure of bioactivity and potency to easily solve your requirements.
CD Formulation can provide one-stop services of the analytical method validation of bioactivity and potency for bio-pharmaceuticals, including validation proposal (validation design, validation indicators, reasonable acceptance standards and data analysis plan, etc.) record of validation results, validation strategy, method monitoring and re-validation.
If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.