Approaches and Regulatory Considerations for the Development of Potency Tests of Early Stage Biological Products.
by Andy Upsall (Antibody Analytics) and Richard Turner (Scendea)
INTRODUCTION
Successful approval of biological medicinal products in the EU and US require characterisation of biological products’ properties to enable the setting of specifications that control the molecule’s critical quality attributes (CQA) for release into the clinic and onto the market. Release specifications ensure manufacturing lot to lot consistency, product stability, and ultimately, patient safety.
CQAs centre around the most influential product attributes and include physicochemical properties, biological activity, immunochemical properties, purity and impurities. CQAs are selected based upon knowledge of the product, manufacturing capability and clinical experience generated through the development phases of the intended molecule…