Guidance On mAbs, Therapeutic Proteins Potency Issued By FDA

The FDA has gone on to issue guidance on March 2, 2023 in order to give out recommendations to sponsors that will help in monoclonal antibodies- mAbs creation as well as other therapeutic proteins which go on to target host cell proteins or viral proteins that interfere with an infection’s pathogenic mechanism.

One of the critical quality control measures surrounding these products happens to be the execution of potency assays, which are adequate to ensure that there is a consistent production that takes place in each lot with the thrust that is necessary to attain clinical efficacy and that the potency gets maintained across the shelf life of the product.

According to the new guidance, a detailed recommendation to the drug manufacturers is provided with the objective of helping to make sure that drug developers give out necessary and precise information so as to access the potency at a product’s life cycle’s each and every stage.

Moreover, it describes approaches and processes the sponsors must make use of in order to develop the potency assay methods when it comes to the release and stability that go on to assess the comprehensively known or potential mechanisms that lead to the action of the product.

The new guidance also describes the methodology that the sponsors must make use of so as to ensure the potency of mAbs as well as other therapeutic proteins, which are made with the intent to prevent as well as treat viral infection.