Drugs

Guidance on Assay Development, Validation for Immunogenicity

FDA has released a guidance on “Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products” that provides recommendations to help industry’s development and validation of immune assays for assessing the immunogenicity of therapeutic protein products during clinical trials. It includes input on developing and validating screening, confirmatory, titering and neutralization assays. The agency says the recommendations apply to assays for detecting anti-drug antibodies, and they may also apply to some combination products on a case-by-case basis.

“The optimal time to design, develop, and validate ADA assays during therapeutic protein product development depends on the risk assessment of the product,” FDA says. “The sponsor should provide a rationale for the immunogenicity testing paradigm, preferably at the investigational new drug application (IND) stage, during Phase 1. Because ADA assays are critical when immunogenicity poses a high clinical risk( e.g., assessment of a therapeutic protein product with a non-redundant endogenous counterpart) and real-time data concerning patient responses are needed, the sponsor should implement preliminary validated assays early, before and during Phase 1, and obtain data in real time. Real-time assessments entail analyses of the samples as soon as possible after sampling, before banking of the samples, and prior to additional dosing when the dosing regimen allows.”

The agency says that in lower risk situations, the sponsor may bank patient samples so they can be tested when suitable assays are available. It encourages sponsors to test samples during Phase 1 and 2 studies using suitable assays. “Samples derived from pivotal studies should be tested with fully validated assays,” it says. “At the time of license application, the sponsor should provide data supporting full validation of the assays.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome