Approaches and Regulatory Considerations
For the Development of Potency Tests of Early Stage Biological Products
Authors:
Andy Upsall - Antibody Analytics
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. Specifications, justified using historical data obtained from the assessment of early production lots used in pre-clinical and/or clinical studies, enable a manufacturer to ensure products remain safe and effective for patients. Through development, CQAs may be measured using various analytical methods; developers are faced with the critical decision to select phase-appropriate strategies when assigning tests and acceptance criteria that minimise risk to patients. Among these decisions, defining how best to measure biological activity is frequently the most challenging and it is common to utilise different testing strategies as a product progresses through the different phases of development.
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