# Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/immunogenicity-testing-of-therapeutic-protein-products-developing-and-validating-assays-for-anti-drug-antibody-detection/ea78d6b5-b969-4817-b06b-f7e0cfa9b536

> FDA guidance document: Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection. Issue date: February 01, 2019. Get complete insights and analysis.

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## Details

- Title: Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-02-01
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2009-D-0539">FDA-2009-D-0539</a>

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