INSTITUTION PROFILE / CELL CULTURE TECHNOLOGY
United States Pharmacopeia (USP)
A private standards body whose compendium is written into US drug law
USP is a private, non-profit organisation, not a government agency. Even so, the Federal Food, Drug, and Cosmetic Act (FD&C Act) names its book of drug quality standards, USP–NF, as an "official compendium" in the text of the statute, so medicines sold in the United States are bound by those standards. In cell culture technology, USP has chapters on how to approach the development of cell therapies, on the reagents, serum and growth factors used in culture, and on test methods for single-use components. This profile looks at one question only: how much influence USP actually has over cell culture technology, focusing on its legal standing and its geographic reach.
What this article covers
- USP 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. USP in 30 seconds
FULL NAMEUnited States Pharmacopeial ConventionKnown as USP. Its compendium is called USP–NF
COUNTRYUnited StatesHeadquarters in Rockville, Maryland. Laboratories in Brazil, China, India and the US
TYPE OF BODYPrivate, non-profit scientific organisationStates explicitly that it is not a government agency
ESTABLISHED1820Began when a group of physicians drew up quality standards for medicines
STAFFAbout 1,200As stated on the careers pages of its website. Standards are written and approved by volunteer experts
MEMBERSMore than 450 organisationsThe USP Convention, drawn from academia, government, industry and patient groups, among others
ROLE IN CELL CULTURE TECHNOLOGYWriting test methods and quality standardsNo power to enforce them (enforcement lies with the FDA and other authorities)
REACHMedicines sold in the USBy USP's account, written into law in more than 40 countries and used in more than 140
The one thing to grasp first
USP writes the standards; it does not make anyone follow them. USP itself says it has no role in enforcing the provisions that recognise USP–NF standards, and that enforcement is the responsibility of the FDA and other government authorities in the US and elsewhere Sourced. The second thing that matters is the chapter number. According to USP's FAQ, chapters numbered 1000 to 1999 are informational and contain no mandatory tests. Chapters below 1000 become mandatory only when a monograph (the standard for an individual article) or another official text refers to them Sourced. The cell therapy chapters <1046> and <1043>, and <1665> for single-use components, all sit in the 1000 range, so none of them is binding in its own right.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, none of the institutions that appear in cell culture coverage makes cells or medicines itself. 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
Among the general chapters of USP–NF, the main ones that bear directly on cell culture technology are listed below Sourced. The "Binding force" column applies the numbering rule set out in USP's FAQ.
| Chapter | Official title | What it covers | Binding force |
|---|---|---|---|
| <1046> | Cell-Based Advanced Therapies and Tissue-Based Products (2020 version) | A broad overview of development considerations for products in which human or animal cells are put into the body to repair, replace or regenerate tissues and organs | Informational (1000 range) |
| <1043> | Ancillary Materials for Cell, Gene, and Tissue-Engineered Products (2019 version) | The many, often complex reagents and materials (ancillary materials) used to manufacture cell, gene and tissue-engineered products | Informational (1000 range) |
| <92> | Growth Factors and Cytokines Used in Cell Therapy Manufacturing (2017 version) | Tests, procedures and acceptance criteria for growth factors and cytokines. Reference standards include rHuman Interleukin 4 RS | Below 1000. Mandatory if referenced by a monograph or other official text |
| <90> | Fetal Bovine Serum—Quality Attributes and Functionality Tests (2021 version) | Quality attributes of the fetal bovine serum (FBS) used in culture, and tests of how well it supports cell growth. Reference standard: Fetal Bovine Serum RS | Below 1000. Mandatory if referenced by a monograph or other official text |
| <1071> | Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach (2019 version) | Risk-based rapid tests for products, including cell and gene therapies, that cannot wait for a sterility test needing 14 days or more of incubation before release | Informational (1000 range) |
| <665> | Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products | Testing for the substances that can be extracted (extractables) from single-use bags, tubing, filters and similar parts. Became official on 1 May 2026 | Below 1000, but USP itself states that it is informational and has no compendial applicability unless a regulatory authority or similar body specifies it |
| <1665> | Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products (2021 version) | Characterisation and qualification of the plastic components and systems used in manufacturing. Cytiva says it took its risk-assessment framework from <665> and <1665> | Informational (1000 range) |
Chapter titles are USP's official English titles. We have not been able to confirm whether <92> or <90> is referenced by any individual monograph Not yet confirmed.
A materials engineer's view: <665> moves component makers even without legal force
<665> sets out which solvents to use, and how, when extracting and measuring the substances that can leach into a drug solution from plastic parts such as single-use culture bags and tubing. Sartorius writes that it provides data using the extraction solvents specified in <665> (50% ethanol, pH 3 and pH 10) plus pure ethanol and pure water. Cytiva, in an article from May 2026, says it provides <665>-aligned extractables data for its own components, and quotes the line in <665> stating that the applicant for the final drug product bears ultimate responsibility for the risk assessment Sourced. So although it is informational in legal terms, <665> serves as a common yardstick that drug makers use in their regulatory submissions, and that gives it the power to bring component makers' data into line. For how the components themselves work, see our explainer on single-use systems.
4. How far its influence reaches (powers and geography)
| Aspect | What USP has | What it does not have |
|---|---|---|
| Powers | The power to write and revise USP–NF standards (drafted and approved by volunteer expert committees). A role in setting drugs' established names (FD&C Act section 502(e)) | The power to enforce. Acting on violations, inspecting and approving are the work of the FDA and other governments. USP states that it has no role in enforcement |
| Legal effect | The FD&C Act defines "official compendium" as USP, NF and others, and a drug recognised in an official compendium that falls below its standards is deemed adulterated. Biologics, including those approved through a BLA, are covered too | The power to make chapters 1000 to 1999 mandatory. They become mandatory only where the FDA or another authority explicitly requires them, for example in regulations |
| Geography | Monograph standards apply to medicines sold in the US. Outside the US, USP says its standards are written into the laws of more than 40 countries and used in more than 140. Test methods are harmonised with the European, Japanese and Indian pharmacopoeias through the PDG | Direct legal force in other countries. They apply elsewhere only where a country's law has adopted USP |
| Scale | About 1,200 staff and more than 450 member organisations. Government liaisons from the FDA and others also sit on the expert committees | Programmes that hand out research funding (none mentioned in the primary sources we checked) |
The line "medicines sold in the US" is drawn by where a product is sold, not where it is made. Biopharmaceutical makers and CDMOs in Japan, Europe, Korea and China that export to the US therefore need to keep USP–NF standards in mind for the products they ship there Our calculation.
A note on reading the numbers
USP's count of the countries that use its standards differs from page to page. The overview page says more than 150, the legal recognition page says more than 140, and a May 2025 news release says the standards are written into law in more than 40 countries and used in more than 140 Sourced. All of these are USP's own descriptions, and none of the primary sources we checked lists which countries reference which chapters in their law Not yet confirmed. Note also that being "used" is not the same as being legally required.
5. Companies and organisations involved
| Organisation or company | Relationship with USP (as stated in primary sources) | Link to this series |
|---|---|---|
| FDA (U.S. Food and Drug Administration) | Enforces USP–NF standards. Government liaisons from the FDA and others sit on the expert committees | See our profile of the U.S. Food and Drug Administration |
| EDQM (European Pharmacopoeia), Japanese Pharmacopoeia (MHLW) and Indian Pharmacopoeia Commission | Harmonise test methods through the PDG, which was founded in 1989. India joined formally in October 2023, and the WHO has been an observer since May 2001 | See our profiles of the Ministry of Health, Labour and Welfare and the European Medicines Agency |
| ICH | When it postponed the official date of <665>, USP said it would follow the development of ICH Q3E (extractables and leachables) | See our profile of the International Council for Harmonisation |
| Cytiva | Generates extractables data for its own single-use and filtration components through a dedicated <665>-aligned programme (article of 11 May 2026) | See our Cytiva profile |
| Sartorius | Provides data using the <665> extraction solvents plus pure ethanol and pure water, and software that predicts extractables levels | See our Sartorius profile |
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| The next question for single-use components is whether <665> becomes a mandatory "applicable" chapter | In its 2022 notice, USP said it would discuss with stakeholders whether <665> should be made an applicable chapter, and pushed its official date back to 1 May 2026 to follow the progress of ICH Q3E. The DOI page published after it became official still describes it as informational | Inference |
| Even without a legal requirement, <665>-aligned extractables data will become a de facto condition for choosing components | Cytiva and Sartorius both officially promote the supply of <665>-aligned data | Inference |
| In cell therapy, USP's influence will spread through test methods and reference standards rather than through obligations | The main cell therapy chapters (<1046>, <1043> and <1071>) sit in the 1000 range and are informational, while <90> and <92> come with reference standards that can be purchased | Inference |
7. Glossary
- Official compendium
- An official book of drug quality standards as defined in the FD&C Act: the United States Pharmacopeia, the Homeopathic Pharmacopeia of the United States and the National Formulary, together with their supplements.
- USP–NF
- The combined compendium of the United States Pharmacopeia (USP) and the National Formulary (NF), carrying standards for drugs and excipients.
- Monograph
- The standard for an individual drug or ingredient (name, identification tests, assay, impurities and so on). Monographs apply to articles sold in the US.
- General chapter
- A chapter setting out test methods or principles used across many articles. Chapters below 1000 are mandatory when referenced; chapters 1000 to 1999 are informational.
- Extractables and leachables (E&L)
- Substances that could come out of plastic components (extractables) and those that actually migrate into the product (leachables).
- PDG
- The Pharmacopeial Discussion Group, the forum in which the US, European, Japanese and Indian pharmacopoeias align their test methods.
8. References
- USP About the United States Pharmacopeia: a private, non-profit scientific organisation, standards used in more than 150 countries, about 1,200 staff. https://www.usp.org/about
- USP Legal Recognition of USP Standards: not a government agency, legal recognition in the US and elsewhere with use in more than 140 countries, and the countries where its laboratories are located. https://www.usp.org/about/legal-recognition
- USP Legal Recognition – Standards Categories: its standing since the FD&C Act was passed in 1938, the adulteration and misbranding provisions, application to biologics, USP having no role in enforcement, and its role in established names. https://www.usp.org/about/legal-recognition/standard-categories
- USP FAQ, "Identifying Official Text": the scope of monographs and the treatment of chapters below 1000 and from 1000 to 1999. https://www.usp.org/frequently-asked-questions/identifying-official-text
- USP USP Convention: history since 1820 and more than 450 member organisations. https://www.usp.org/about/usp-convention
- USP News release, "USP announces newly elected Council of Experts for the 2025-2030 cycle" (Rockville, 16 May 2025): liaisons from the FDA and others, standards written into law in more than 40 countries and used in more than 140. https://www.usp.org/news/usp-announces-newly-elected-council-of-experts-for-the-2025-2030-cycle
- USP USP Volunteers: all standards are written and approved by volunteer experts. https://www.usp.org/about/volunteer-experts
- US Government (GovInfo) 21 U.S.C. 321 (FD&C Act section 201; subsection (j) defines "official compendium"). https://www.govinfo.gov/content/pkg/USCODE-2023-title21/html/USCODE-2023-title21-chap9-subchapII-sec321.htm
- US Government (GovInfo) 21 U.S.C. 351 (FD&C Act section 501; under subsection (b), a drug that differs from compendial standards is adulterated). https://www.govinfo.gov/content/pkg/USCODE-2023-title21/html/USCODE-2023-title21-chap9-subchapV-partA-sec351.htm
- USP–NF <1046> Cell-Based Advanced Therapies and Tissue-Based Products (2020 version). https://doi.usp.org/USPNF/USPNF_M99766_03_01.html
- USP–NF <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products (2019 version). https://doi.usp.org/USPNF/USPNF_M620_02_01.html
- USP–NF <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing (2017 version; reference standards). https://doi.usp.org/USPNF/USPNF_M3507_01_01.html
- USP–NF <90> Fetal Bovine Serum—Quality Attributes and Functionality Tests (2021 version; reference standard). https://doi.usp.org/USPNF/USPNF_M3064_03_01.html
- USP–NF <1071> Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach (2019 version). https://doi.usp.org/USPNF/USPNF_M12457_02_01.html
- USP–NF <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products (with a note that the chapter is informational and has no compendial applicability unless specified by a regulatory authority or similar body). https://doi.usp.org/USPNF/USPNF_M11135_02_01.html
- USP–NF <1665> Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products (2021 version). https://doi.usp.org/USPNF/USPNF_M11136_02_01.html
- USP–NF <665> Notice of Intent to Revise (25 February 2022): no mandatory requirements, official date postponed to 1 May 2026, and the intention to follow the progress of ICH Q3E. https://www.uspnf.com/notices-665-nitr-20220225
- USP–NF Revision Bulletins: <665> posted 29 April 2022, official from 1 May 2026. https://www.uspnf.com/official-text/revision-bulletins
- USP Pharmacopeial Discussion Group (PDG): founded in 1989 by the EDQM, USP and the Japanese Pharmacopoeia; the Indian Pharmacopoeia Commission joined in October 2023, and the WHO takes part as an observer. https://www.usp.org/harmonized-standards/pdg
- Cytiva "A customer's journey to navigating USP <665> compliance" (11 May 2026). https://www.cytivalifesciences.com/en/us/insights/usp-665-compliance-extractables-leachables
- Sartorius "Assessing the Risk of Extractables and Leachables on Biopharmaceutical Processes": the <665> extraction solvents, the company's additional solvents and its Extractables Simulator. https://www.sartorius.com/en/knowledge/science-snippets/blog-assessing-the-risk-of-extractables-and-leachables-1275346
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| A private, non-profit scientific organisation; standards used in more than 150 countries; about 1,200 staff | Sourced | Reference 1 https://www.usp.org/about |
| Not a government agency; used in more than 140 countries; laboratories in Brazil, China, India and the US | Sourced | Reference 2 https://www.usp.org/about/legal-recognition |
| Standing under the FD&C Act, application to biologics (including BLA products), USP having no role in enforcement, and its role in established names (section 502(e)) | Sourced | Reference 3 https://www.usp.org/about/legal-recognition/standard-categories |
| Monographs apply to articles sold in the US; chapters below 1000 are mandatory when referenced; chapters 1000 to 1999 are informational | Sourced | Reference 4 https://www.usp.org/frequently-asked-questions/identifying-official-text |
| Founded in 1820; more than 450 member organisations | Sourced | Reference 5 https://www.usp.org/about/usp-convention |
| Headquarters in Rockville; liaisons from the FDA and others on the expert committees; written into law in more than 40 countries and used in more than 140 | Sourced | Reference 6 https://www.usp.org/news/usp-announces-newly-elected-council-of-experts-for-the-2025-2030-cycle |
| Standards are written and approved by volunteer experts | Sourced | Reference 7 https://www.usp.org/about/volunteer-experts |
| The definition of "official compendium" (USP, HPUS, NF and their supplements) | Sourced | Reference 8 https://www.govinfo.gov/content/pkg/USCODE-2023-title21/html/USCODE-2023-title21-chap9-subchapII-sec321.htm |
| A drug recognised in an official compendium that falls below its standards is deemed adulterated | Sourced | Reference 9 https://www.govinfo.gov/content/pkg/USCODE-2023-title21/html/USCODE-2023-title21-chap9-subchapV-partA-sec351.htm |
| Scope and version of <1046> | Sourced | Reference 10 https://doi.usp.org/USPNF/USPNF_M99766_03_01.html |
| Scope and version of <1043> | Sourced | Reference 11 https://doi.usp.org/USPNF/USPNF_M620_02_01.html |
| Scope, version and reference standards of <92> | Sourced | Reference 12 https://doi.usp.org/USPNF/USPNF_M3507_01_01.html |
| Scope, version and reference standard of <90> | Sourced | Reference 13 https://doi.usp.org/USPNF/USPNF_M3064_03_01.html |
| Scope of <1071> (short-life products, including cell and gene therapies, for which a sterility test of 14 days or more cannot finish in time) | Sourced | Reference 14 https://doi.usp.org/USPNF/USPNF_M12457_02_01.html |
| <665> is informational and has no compendial applicability unless a regulatory authority or similar body specifies it | Sourced | Reference 15 https://doi.usp.org/USPNF/USPNF_M11135_02_01.html |
| Title and version of <1665> | Sourced | Reference 16 https://doi.usp.org/USPNF/USPNF_M11136_02_01.html |
| <665> contains no mandatory requirements; its official date was postponed to 1 May 2026; USP would follow the progress of ICH Q3E | Sourced | Reference 17 https://www.uspnf.com/notices-665-nitr-20220225 |
| <665> official date of 1 May 2026 | Sourced | Reference 18 https://www.uspnf.com/official-text/revision-bulletins |
| The PDG's founding year and participants | Sourced | Reference 19 https://www.usp.org/harmonized-standards/pdg |
| Cytiva supplies <665>-aligned extractables data; the line in <665> placing ultimate responsibility on the applicant; Cytiva's risk-assessment framework drawn from <665> and <1665> | Sourced | Reference 20 https://www.cytivalifesciences.com/en/us/insights/usp-665-compliance-extractables-leachables |
| Sartorius's additional solvents and Extractables Simulator | Sourced | Reference 21 https://www.sartorius.com/en/knowledge/science-snippets/blog-assessing-the-risk-of-extractables-and-leachables-1275346 |
| The four types of institution and the colour coding of the lines in Fig. 2 | Our calculation | Our own classification |
| Because the line is drawn by where a product is sold, non-US makers that export to the US are also covered | Our calculation | This article's reading of "applies to articles sold in the US" in reference 4 |
| Whether <90> and <92> are referenced by monographs or other official texts | Not yet confirmed | Not confirmed in references 4, 12 or 13; this article makes no judgement on it |
| A list of which countries reference which chapters in their law | Not yet confirmed | Not stated in references 1, 2 or 6; this article does not estimate it |
| The three points in the outlook (section 6) | Inference | This article's reading of references 4, 12 to 15, 17, 20 and 21 |
Last updated 24 September 2026 / Troy Technical
This article is based on USP's official website, the DOI pages and notices for individual USP–NF chapters, the United States Code, and official material from makers of single-use components. Items marked "Inference" are this article's reading of the primary information, not statements by USP.