# Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/points-to-consider-in-the-manufacture-and-testing-of-monoclonal-antibody-products-for-human-use/a46ecfe6-3346-4604-96dc-b32e5e663fff

> FDA guidance document: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. Issue date: February 28, 1997. Get complete insights and analysis.

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## Details

- Title: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 1997-02-28
- Last Changed: 2020-04-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1994-D-0318">FDA-1994-D-0318</a>

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