Biologics

Draft Guidance on Potency Testing for Active Immunotherapy Products

FDA has issued a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products (ACTIMPs), including personalized cancer immunotherapies, vectored products and cell-based therapies.

The document, “Potency Assessment of Active Immunotherapy Products,” is intended to provide a science- and risk-based framework for evaluating whether ACTIMPs have the ability to produce their intended therapeutic effect. It is focused on products that treat existing diseases by inducing, stimulating or modulating immune effector cells through introduction of disease-associated antigens.

“Recent advances in genomics and new knowledge regarding mutation load in tumor cells have led to rapid improvements in ACTIMPs intended to treat cancer through induction of anti-cancer immune responses,” the agency says. “ACTIMPs also include products intended to treat autoimmune disease by inducing immune tolerance against specific antigens associated with that autoimmune disease.”

The guidance does not cover preventive vaccines for infectious diseases, bacteriophage products for infectious diseases, live biotherapeutic products, fecal microbiota transplantation products or allergenic products.

FDA notes that assessing potency can be particularly challenging for ACTIMPs because their biological activity depends on the patient's immune response rather than solely on a direct effect of the product. The challenge can be greater for personalized products, particularly those incorporating patient-specific neoantigens for cancer treatment, because product-specific reagents may not be readily available for every lot, it adds.

The agency is proposing a flexible approach in which potency assays are developed according to the product's mechanism of action and potency-related critical quality attributes (CQAs). It recommends that potency assays be quantitative and sufficiently precise to distinguish a product with enough activity to produce its intended therapeutic effect from one with insufficient activity, adding that the assays should allow manufacturers to identify and reject subpotent lots.

The agency recommends measuring potency-related CQAs during lot-release testing and establishing acceptance criteria to ensure consistent performance between ACTIMP lots. However, it says a lot-release assay for a particular CQA may not be necessary if other elements of a product's process design or control strategy adequately ensure that the CQA remains within acceptable limits.

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