The FDA just released a draft guidance "Potency Assessment of Active Immunotherapy Products" for comment. It introduces a new acronym for me: ACTIMPs for active immunotherapy products. And define ACTIMPs within the Background section as "ACTIMPs may be vectors that express antigens, peptide or protein antigens, or cells that present or express antigens (e.g., cell lysates or antigen-pulsed antigen presenting cells (APCs)). A subset of ACTIMPs are intended to treat cancer by activating immune cells that target tumor-specific antigens and/or tumor-associated antigens (TAAs), including neoantigens and viral antigens expressed by virus-transformed cancer cells. 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. ACTIMPs also include products intended to treat autoimmune disease by inducing immune tolerance against specific antigens associated with that autoimmune disease."
Further on when considering the challenges of potency assays, it notes "However, assessment of ACTIMP's potency is challenging because the biological activity relies on immune responses. The challenge can be even greater for individualized (personalized) therapeutic ACTIMPs, where the use of patient-specific neoantigens raises unique considerations for designing potency assays, including limited availability of specific reagents for each product lot (e.g., where there is no readily available antibody to measure expressed antigen)."
In that context, the Agency then sets forth the content and approach of the guidance "In this guidance, we discuss a science- and risk-based approach (Ref. 3) to developing suitable potency assays for ACTIMPs. We also provide specific examples of assays that can help assure the potency of various types of ACTIMPs. "
For those working on ACTIMPs, reading and responding to this guidance will be important to ensure it aligns with today's science and achievable practices.
#ACTIMPs #PotencyAssay #fda
Potency Assessment of Active Immunotherapy Products
| U.S. Food and Drug Administration |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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