Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use

Description

Points to Consider documents provide a flexible approach in which FDA provides and updates its guidance on regulatory issues in many areas of drug development. Such documents are particularly useful in the rapidly evolving field of biotechnology-derived drugs and other biologics. The Center for Biologics Evaluation and Research (CBER) set out to revise the "Points to Consider (PTC) in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" with several objectives. An important goal was to facilitate initial development of monoclonal antibodies for serious or life threatening indications.  Additionally, it was felt that some of the information in the 1994 document required updating and streamlining. Finally, it was necessary to review this document for consistency with current CBER policy and with International Conference on Harmonisation (ICH) documents dealing with this category of products. This updated document supersedes the 1994 version, and is designed to assist sponsors and investigators regarding monoclonal antibody (mAb) product development, including information to submit when filing Investigational New Drug Applications ("INDs") and License Applications.  Although this document does not create or confer any rights for or on any person and does not operate to bind FDA or the public, it does represent the agency’s current thinking on monoclonal antibody products for human use.

Scope & Applicability

Regulatory Context

• 21CFR361.1§ 361.1 Radioactive drugs for certain research uses.

  (a) Radioactive drugs (as defined in § 310.3(n) of this chapter ) are generally recognized as safe and effective when administered, under the conditions set forth in paragraph (b) of this section, to human research subjects during the course of a research project intended to obtain basic informationRead full regulation →

• 21CFR312.23§ 312.23 IND content and format.

  (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →

• 21CFR610.15§ 610.15 Constituent materials.

  (a) Ingredients, preservatives, diluents, adjuvants. All ingredients used in a licensed product, and any diluent provided as an aid in the administration of the product, shall meet generally accepted standards of purity and quality. Any preservative used shall be sufficiently nontoxic so that the amRead full regulation →

• 21CFR610.14§ 610.14 Identity.

  The contents of a final container of each filling of each lot shall be tested for identity after all labeling operations shall have been completed. The identity test shall be specific for each product in a manner that will adequately identify it as the product designated on final container and packaRead full regulation →

• 21CFR610.9§ 610.9 Equivalent methods and processes.

  Modification of any particular test method or manufacturing process or the conditions under which it is conducted as required in this part or in the additional standards for specific biological products in parts 620 through 680 of this chapter shall be permitted only under the following conditions:Read full regulation →

• 21CFR610.12§ 610.12 Sterility.

  (a) The test. Except as provided in paragraph (h) of this section, manufacturers of biological products must perform sterility testing of each lot of each biological product's final container material or other material, as appropriate and as approved in the biologics license application or supplemenRead full regulation →

• 21CFR610.13§ 610.13 Purity.

  Products shall be free of extraneous material except that which is unavoidable in the manufacturing process described in the approved biologics license application. In addition, products shall be tested as provided in paragraphs (a) and (b) of this section.Read full regulation →

• 21CFR610.10§ 610.10 Potency.

  Tests for potency shall consist of either in vitro or in vivo tests, or both, which have been specifically designed for each product so as to indicate its potency in a manner adequate to satisfy the interpretation of potency given by the definition in § 600.3(s) of this chapter .Read full regulation →

• 21CFR600.3§ 600.3 Definitions.

  As used in this subchapter:Read full regulation →

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• Good Laboratory Practice (GLP)

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  2022-02-22

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  University of Kentucky

  2020-05-05

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