INSTITUTION PROFILE / CELL CULTURE TECHNOLOGY
U.S. Food and Drug Administration (FDA)
The regulator you answer to if you sell in the U.S., wherever you make the product
The FDA is a U.S. federal regulator. It makes neither cells nor medicines. Its job is to review and approve the medicines and cell therapy products sold in the United States, and to inspect the sites where they are made. Cell and gene therapies are handled by the Center for Biologics Evaluation and Research (CBER); therapeutic proteins made in cell culture, such as antibodies, by the Center for Drug Evaluation and Research (CDER). Its authority covers the U.S. market, but any product sold in the U.S. is subject to FDA review and inspection, even if the plant is in China or Italy. This profile looks at one question only: how much influence the FDA has over cell culture technology.
- The FDA in 30 seconds
- What kind of body it is: the four types of influence
- What it does in cell culture technology
- How far its influence reaches (powers and geography)
- Companies and organisations involved
- Outlook
- Glossary, references and claim-to-source audit
1. The FDA in 30 seconds
The FDA's power is the power to decide what gets into the U.S. market. According to the FDA, about 96% of biologics sales in the U.S. are imports, and alongside 5,529 FDA-registered biologics facilities at home there are 697 abroad Sourced. In other words, any company that uses cell culture to make medicines or cell products has to meet FDA standards for as long as it sells in the U.S., wherever its headquarters or plants are. That is why a single U.S. agency shapes cell culture work around the world.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, the institutions that appear in cell culture coverage make neither cells nor medicines. What separates them is the route by which they influence the industry, and that gives four types.
3. What it does in cell culture technology
Within the FDA, cell culture technology falls mainly to two centres. On 30 June 2003, therapeutic proteins such as antibodies (monoclonal antibodies for in vivo use), cytokines and enzymes were transferred from CBER to CDER, while products composed of cells, gene therapy products and human cells, tissues, and cellular and tissue-based products (HCT/Ps) stayed with CBER Sourced. CBER reorganised the office that had handled cell and gene therapies into a new super office, scheduled to take effect on 26 February 2023: the Office of Therapeutic Products (OTP) Sourced.
| Function | What it involves | Legal basis | Relevance to cell culture technology |
|---|---|---|---|
| Approval (BLA) | Reviews applications to license biologics and authorises their sale in the U.S. CBER publishes a list of the cellular and gene therapy products it has approved | Public Health Service Act (PHS Act) and Federal Food, Drug, and Cosmetic Act (FD&C Act) | The list includes the CAR-T therapies KYMRIAH and AUCATZYL, the mesenchymal stem cell product RYONCIL, and MACI, made from cultured chondrocytes |
| Expedited designation (RMAT) | A designation for regenerative medicine therapies for serious conditions whose preliminary clinical evidence indicates the potential to address unmet medical needs. The FDA tells the sponsor within 60 days of the request whether it has been granted | Section 3033 of the 21st Century Cures Act | Covers cell therapies, therapeutic tissue engineering products and similar products. In this series, Allogene Therapeutics holds the designation (section 5) |
| Rules for cells and tissues | Registration of establishments that make HCT/Ps, donor eligibility, and current good tissue practice (CGTP) to prevent the spread of communicable disease | 21 CFR Part 1271 of the Code of Federal Regulations | Even cell therapies that need approval must follow the donor eligibility and CGTP procedures |
| Plant inspections | Inspects manufacturing facilities in the U.S. and abroad. On 6 May 2025 it announced expanded use of unannounced inspections at foreign manufacturing facilities | FDA announcement, which says the agency can take regulatory action against firms that delay or refuse inspection | Covers overseas contract development and manufacturing organisations (CDMOs) that make products for the U.S. by cell culture |
| Support for U.S. manufacturing (PreCheck) | A pilot programme that gives technical advice to companies building new plants in the U.S., before the plants start operating. Seven participants were selected on 29 June 2026 | FDA announcement (more than 80 applications received in February and March 2026) | The seven include FUJIFILM Biotechnologies' commercial-scale cell culture plant in North Carolina and Cellares, which makes cell-based gene therapies |
Antibody drugs made by culturing cells such as CHO cells go to CDER; cell therapies, in which the patient's or a donor's own cells are cultured and processed, go to CBER. For a supplier of culture media or equipment, this means the rules that apply, and the reviewers the customer deals with, depend on which kind of product the customer makes. Cell therapies also carry an extra layer: even products that need approval must follow the donor eligibility and CGTP procedures of 21 CFR Part 1271 Sourced. Our explainers on GMP, CAR-T cells, and antibody drugs and ADCs help make the difference clearer.
4. How far its influence reaches (powers and geography)
| Aspect | What the FDA has | What it does not have |
|---|---|---|
| Powers | Review of clinical trials, the decision to approve or not, designations such as RMAT, the HCT/P rules, and inspection of plants at home and abroad. Regulatory action against firms that delay or refuse inspection | Making or selling products itself (its role is limited to review and oversight) |
| Geography | The U.S. market, wherever the product is made. Of 6,226 registered biologics facilities, 697 are outside the U.S. | Any power to decide what may be sold outside the U.S. Any authority over foreign plants that do not ship to the U.S. |
| International influence | A founding regulatory member of ICH (one of three, alongside Europe and Japan). Adopts ICH guidelines as U.S. guidance | Any power to bind other regulators' approval decisions |
| Scale | 20,593 FTEs and a budget of about US$7 billion (FY2025, all programmes combined) | Staff and budget figures for CBER alone do not appear in the sources used for this article |
The 20,593 FTEs and US$7 billion are figures for the whole FDA, including food, tobacco and medical devices, and are based on the FY2025 budget Sourced. We could not find staff or budget figures limited to CBER or OTP, the parts that handle cell and gene therapies, in the sources used for this article Not yet confirmed. Note also that "about 96% of biologics sales are imports" and "about one in ten registered facilities (697 of 6,226) is abroad" measure different things, sales and facility counts, so they cannot be compared directly Our calculation.
5. Companies and organisations involved
Beyond the three examples in Fig. 2, Allogene's cema-cel received Fast Track designation at the same time as RMAT, and the company also holds RMAT designations for ALLO-316 and ALLO-715 (see our Allogene Therapeutics profile) Sourced. WuXi Biologics discloses that 23 of the 49 regulatory inspections it has undergone since 2017 were by the EMA and FDA Sourced. The FDA's reach, in other words, extends beyond the developers that seek approval to the overseas plants that make their materials or manufacture under contract.
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| Having a cell culture plant in the U.S. will increasingly be an advantage, including in how smoothly regulatory review goes | PreCheck is open only to new plants in the U.S., and the seven participants chosen in June 2026 include a commercial-scale cell culture plant and a plant for cell-based gene therapies | Inference |
| CDMOs in Asia and Europe that make products for the U.S. will have to put more effort into being ready for unannounced inspections | The May 2025 announcement on expanding foreign inspections. Sites of WuXi Biologics (China) and AGC Biologics (Italy) are being reviewed for products bound for the U.S. | Inference |
| In safety testing for antibody drugs, tests using cell lines or organoids instead of animals will carry more weight | On 10 April 2025 the FDA announced a plan to phase out animal testing requirements for monoclonal antibodies and other drugs, naming tests with cell lines and organoids among the alternatives | Inference |
7. Glossary
- CBER / CDER
- The FDA's review centres. CBER handles cell and gene therapies, vaccines, blood and related products; CDER handles conventional drugs and therapeutic proteins such as antibodies.
- BLA
- Biologics License Application. Once it is approved, the product can be sold in the U.S.
- RMAT designation
- Regenerative Medicine Advanced Therapy designation. Granted to a regenerative medicine therapy for a serious condition when preliminary clinical evidence shows promise.
- HCT/P
- Human cells, tissues, and cellular and tissue-based products. 21 CFR Part 1271 sets out establishment registration, donor eligibility and CGTP.
- Pre-license inspection
- An on-site inspection of a manufacturing facility that the FDA carries out as part of reviewing an application.
- FTE
- Full-time equivalent: a headcount that converts part-time and similar staff into full-time equivalents.
8. References
- FDA FDA at a Glance (January 2026): FY2025 budget of about US$7 billion and its breakdown, 20,593 FTEs, the import share of biologics sales, FDA-registered facilities (biologics: 5,529 domestic, 697 foreign, 6,226 in total) and headquarters location. https://www.fda.gov/media/154548/download
- FDA FDA History: modern regulatory functions beginning with the Pure Food and Drugs Act of 1906, and the adoption of the current name in 1930. https://www.fda.gov/about-fda/fda-history
- FDA Center for Biologics Evaluation and Research (CBER): mission, and the Public Health Service Act and Federal Food, Drug, and Cosmetic Act as its legal basis. https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber
- FDA Establishment of the Office of Therapeutic Products: scheduled launch on 26 February 2023 and the reorganisation of the previous office. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/establishment-office-therapeutic-products
- FDA Transfer of Therapeutic Biological Products to the Center for Drug Evaluation and Research: the transfer of 30 June 2003, and which products moved to CDER and which stayed with CBER. https://www.fda.gov/combination-products/jurisdictional-information/transfer-therapeutic-biological-products-center-drug-evaluation-and-research
- FDA Approved Cellular and Gene Therapy Products: list of approved products (updated 17 September 2026). https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
- FDA Regenerative Medicine Advanced Therapy Designation: section 3033 of the 21st Century Cures Act as the legal basis, the criteria for designation and notification within 60 days. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation
- Electronic Code of Federal Regulations (eCFR) 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (§1271.1, purpose and scope: establishment registration, donor eligibility and CGTP). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
- FDA Press release "FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities" (6 May 2025). https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities
- FDA Press release "FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing" (29 June 2026): the seven participants and their plants, and more than 80 applications. https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing
- FDA Press release "FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs" (10 April 2025). https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs
- ICH Members & Observers: founding regulatory members (EC, Europe; FDA, United States; MHLW/PMDA, Japan). https://www.ich.org/page/members-observers
- Allogene Therapeutics Form 10-Q for the quarterly period ended June 30, 2026 (filed with the U.S. SEC): RMAT and Fast Track designations for cema-cel (July 2026), and RMAT designations for ALLO-316 and ALLO-715. https://www.sec.gov/Archives/edgar/data/1737287/000162828026056213/allo-20260630.htm
- AGC Biologics Press release "AGC Biologics to Manufacture LVV for CAR-T Therapy Approved by FDA for Autolus Therapeutics' AUCATZYL" (11 December 2024). https://www.agcbio.com/news/agc-biologics-to-manufacture-lvv-for-car-t-therapy-approved-by-fda-for-autolus-therapeutics
- WuXi Biologics (Cayman) Inc. Interim Results Announcement for the six months ended June 30, 2026: MFG8 passing a U.S. FDA Pre-License Inspection, and 49 regulatory inspections since 2017 (23 of them by the EMA and FDA). https://cdn.wuxibiologics.com/en/wp-content/uploads/2026/09/20260923170523480.pdf
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Budget of about US$7 billion (51% federal budget authority, 49% user fees), 20,593 FTEs, about 96% of biologics sales imported, registered biologics facilities (5,529 domestic, 697 foreign, 6,226 in total), headquarters location, agency within HHS | Sourced | Reference 1 https://www.fda.gov/media/154548/download |
| Modern regulatory functions began in 1906; current name adopted in 1930 | Sourced | Reference 2 https://www.fda.gov/about-fda/fda-history |
| CBER's legal basis (PHS Act and FD&C Act) | Sourced | Reference 3 https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber |
| OTP was scheduled to launch on 26 February 2023 | Sourced | Reference 4 https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/establishment-office-therapeutic-products |
| Antibodies and similar products moved to CDER on 30 June 2003, while cellular products, gene therapies and HCT/Ps stayed with CBER | Sourced | Reference 5 https://www.fda.gov/combination-products/jurisdictional-information/transfer-therapeutic-biological-products-center-drug-evaluation-and-research |
| Examples of approved products (KYMRIAH, AUCATZYL, RYONCIL, MACI) | Sourced | Reference 6 https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products |
| Legal basis for RMAT (section 3033 of the 21st Century Cures Act), its criteria and notification within 60 days | Sourced | Reference 7 https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation |
| Purpose and scope of 21 CFR Part 1271 (registration, donor eligibility, CGTP; donor eligibility and CGTP also apply to products that need approval) | Sourced | Reference 8 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271 |
| Expanded unannounced inspections at foreign manufacturing facilities (6 May 2025) and regulatory action against firms that refuse inspection | Sourced | Reference 9 https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities |
| The seven PreCheck pilot participants (including FUJIFILM Biotechnologies and Cellares) and more than 80 applications | Sourced | Reference 10 https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing |
| Plan to phase out animal testing requirements for monoclonal antibodies and other drugs (tests using cell lines and organoids) | Sourced | Reference 11 https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs |
| The FDA is a founding regulatory member of ICH | Sourced | Reference 12 https://www.ich.org/page/members-observers |
| Allogene's RMAT and Fast Track designations | Sourced | Reference 13 https://www.sec.gov/Archives/edgar/data/1737287/000162828026056213/allo-20260630.htm |
| FDA approval of AGC Biologics' Milan site for commercial manufacture of vectors for AUCATZYL | Sourced | Reference 14 https://www.agcbio.com/news/agc-biologics-to-manufacture-lvv-for-car-t-therapy-approved-by-fda-for-autolus-therapeutics |
| WuXi Biologics' MFG8 passing an FDA Pre-License Inspection, and 49 inspections (23 by the EMA and FDA) | Sourced | Reference 15 https://cdn.wuxibiologics.com/en/wp-content/uploads/2026/09/20260923170523480.pdf |
| The four types of institution, the choice of the three examples in Fig. 2, and the caution that the sales share and facility count cannot be compared | Our calculation | Our own classification and selection |
| Staff and budget for CBER and OTP alone | Not yet confirmed | Not stated in references 1 to 5; this article does not estimate them |
| The three points in the outlook (section 6) | Inference | This article's reading of references 9 to 11, 14 and 15 |
Last updated 24 September 2026 / Troy Technical
All figures come from the FDA's website and announcements, the U.S. Code of Federal Regulations, the ICH website and disclosures by the companies concerned. Items marked "Inference" are this article's reading of the primary information, not statements by the FDA.