Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products

Description

The use of human- and animal-derived materials  to manufacture cellular and gene therapy (CGT) products and tissue-engineered medical products (TEMPs) raises several key issues to consider, including transmission of adventitious agents, material lot-to-lot consistency, and material identity, as well as general material qualification considerations.  We, FDA, are providing you, manufacturers of CGT and TEMP products, with recommendations regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of these products.  In addition, recommendations are provided regarding the chemistry, manufacturing, and control (CMC) information submitted in an investigational new drug application (IND) relating to the use of human- and animal-derived materials.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR312.42§ 312.42 Clinical holds and requests for modification.

  (a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjectRead full regulation →

• 21CFR211.82§ 211.82 Receipt and storage of untested components, drug product containers, and closures.

  (a) Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.Read full regulation →

• 21CFR211.84§ 211.84 Testing and approval or rejection of components, drug product containers, and closures.

  (a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.Read full regulation →

• 21CFR210.2§ 210.2 Applicability of current good manufacturing practice regulations.

  (a) The regulations in this part and in parts 211 , 213 , 225 , and 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use; and in part 1271 of this chapter as they are applicable to a human cell, tissue, Read full regulation →

• 21CFR610.40§ 610.40 Test requirements.

  (a) Human blood and blood components. Except as specified in paragraphs (c) and (d) of this section, you, an establishment that collects blood and blood components for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medicalRead full regulation →

• CGMP/Finished Pharmaceuticals/Adulterated

  SV Labs Corporation

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Guangdong Renhe Guozhuang Biotechnology Co., Ltd.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Medinatura New Mexico, Inc.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Sklar Personal Care Inc.

  2025-12-16

• CGMP/Deviations/Biologics License Application (BLA)

  Microvascular Tissue, Inc.

  2025-12-16

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  Green Valley Fertility Partners

  2025-12-16

• CGMP/Finished Pharmaceuticals/Adulterated

  Catalent Indiana, LLC

  2025-12-11

• Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

  BioXtek LLC

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  DeVere Manufacturing Inc.

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  CDL Services, Inc. DBA Technichem

  2025-12-09

• Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products (Status: Draft)
• Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
• Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for Industry (Status: Final)
• Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry (Status: Final)
• Drug Master Files for Bulk Antibiotic Drug Substances: Guidance for Industry (Status: Final)
• INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information: Guidance for Industry (Status: Final)
• Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (Status: Final)
• Pharmacogenomic Data Submissions: Guidance for Industry (Status: Final)