Earlier today (01 March, 2023) USFDA released a draft guidance on "Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens".
This guidance aims to offer recommendations to sponsors for developing monoclonal antibodies (mAbs) and other therapeutic proteins that specifically target viral proteins or host cell proteins involved in the pathogenic mechanisms of infection.
Also the purpose of this guidance is to provide drug developers with detailed recommendations that would assist them in providing sufficient information to assess the potency of a product at every stage of its life cycle.
The development and implementation of an effective potency assay(s) is crucial for ensuring consistent production of these products with the necessary potency for achieving clinical efficacy. It is also essential to maintain the potency of the product over its shelf life, making it a critical quality control measure.
This guidance provides sponsors with descriptions of approaches that they should adopt in developing comprehensive potency assay methods for both release and stability testing. The aim is to ensure that these methods assess all known or potential mechanisms of action of the product.
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