TherapeuticBiobank.com

A research collection and a therapeutic bank are different objects

ISO 20387, the international biobanking standard, defines a biobank as a “legal entity or part of a legal entity that performs biobanking”, then draws the line this domain sits on: it “does not apply to biological material intended for … therapeutic use”, and sends entities handling human material “procured and used for diagnostic and treatment purposes” to ISO 15189 and other clinical standards first.1 ISBER puts the boundary in the same place: its repositories hold specimens “intended primarily for research purposes”.2

A therapeutic biobank is therefore not a stricter research biobank but a different regulated object. Once material is intended to go into a person, tissue and medicines law arrives with it and the nouns change: tissue establishment, cell bank, HCT/P, SoHO establishment. No regulator has defined the phrase as a category — it is simply what people say.

Cord blood: the therapeutic bank that already runs at scale

Cord blood is “the blood contained in the placental blood vessels and umbilical cord”, and it is banked two ways. A public bank takes donations for unrelated patients; a private or family bank stores a unit for the child it came from “or for use in first- or second-degree relatives”.3 That difference sets the regulatory route. Units for unrelated patients “must meet additional requirements and be licensed under a biologics license application (BLA), or subject to an investigational new drug application (IND) before use”, while a family unit “does not require approval before use” — though the bank still registers and lists, screens and tests donors, and follows current good tissue practice.3

The public inventory is substantial: the World Marrow Donor Association calls its Search & Match Service “the world’s largest haematopoietic cell donor database, listing 44 million stem cell donors and more than 750,000 cord blood units”.4 NMDP ran its first transplant in 1987, launched a cord blood programme in 1998 and renamed from Be The Match in early 2024.5 The work has rulebooks of its own: NetCord-FACT cord blood standards6 and AABB cord blood accreditation.7

The American line: 21 CFR Part 1271, and 361 against 351

Part 1271 registers and lists the establishments that manufacture “human cells, tissues, and cellular and tissue-based products (HCT/P’s)” and sets procedures against communicable disease.8 An HCT/P is an article “containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient”; vascularised organs, whole blood and blood components are excluded.8

Section 1271.10(a) sets four criteria: minimally manipulated; “intended for homologous use only”; no combination with another article except “water, crystalloids, or a sterilizing, preserving, or storage agent”; and either no systemic effect and no dependence on living-cell metabolism, or autologous, close-relative or reproductive use.8 Meet all four and the product is regulated solely under section 361 of the Public Health Service Act. Miss one and the “HCT/P will be regulated as a drug, device, and/or biological product under the FD&C Act, and/or section 351 of the PHS Act … and premarket review will be required”.9 Minimal manipulation is processing “that does not alter the relevant biological characteristics of cells or tissues”; homologous use means performing “the same basic function or functions in the recipient as in the donor”.8 A bank sits on one side of that line, and its whole quality system follows.

The European line: tissue establishments, GMP, and the SoHO Regulation

Directive 2004/23/EC has carried the job description in its title since 2004: standards of quality and safety “for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells”.10 EU GMP Annex 2 shows where it meets medicines manufacturing. Tissues and cells used as starting materials must be donated, procured and tested “in accordance with Directive 2004/23/EC”; EU supply sites “must hold appropriate approvals from the national competent authority(ies)”; and steps such as freezing fall under the Directive, “which provides for the need of a Responsible Person (RP)” who releases the material before it ships onward.11

Traceability crosses that join both ways — “from the donor to the batch of a finished medicinal product”, with records kept “for 30 years after the expiry date of the medicinal product”, all while “maintaining the privacy of individuals and confidentiality of health related information”.11 Annex 2 states the autologous reality in one sentence: “For autologous and donor-matched situations, the manufactured product should be viewed as a batch.”11

And the frame is moving. Regulation (EU) 2024/1938, the SoHO Regulation, entered into force on 7 August 2024 and applies from 7 August 2027, replacing the blood directive and the tissues and cells directive with one directly applicable regulation covering substances of human origin other than organs, and defining two roles: the SoHO entity and the SoHO establishment.1213

Who inspects a biobank, and against what

• ISO 20387:2018 — requirements for “the competence, impartiality and consistent operation of biobanks”: the accreditable baseline for research collections, expressly not for therapeutic material.1
• ISBER Best Practices, fifth edition (2023) — twelve sections covering a repository from initiation to closure, after editions in 2005, 2008, 2012 and 2018.2
• AABB Standards for Cellular Therapy Services, twelfth edition, effective 1 July 2025 — “donor eligibility and collection, processing, storage, and administration of any type of cellular therapy product”.7
• FACT, with JACIE and NetCord — standards for hematopoietic cellular therapy, immune effector cells, cord blood banking and cellular therapies in common.6

The cold chain, and what it has to prove

Under the paperwork sits a freezer. Published practice for cell therapies is cryopreservation with 5–10% dimethyl sulfoxide, cooling at 1 °C per minute to −80 °C, storage in the vapour phase of liquid nitrogen at roughly −130 °C, rapid thawing at 37 °C, then removal of the DMSO “due to its cytotoxicity at temperatures above 0°C”.14 The temperature is not arbitrary: vapour phase at about −135 °C holds the material below glass transition, and “if the temperature rises above the glass transition point, devitrification can occur”, disrupting the cells.14

The rules ask a bank to prove that cold rather than assert it. Annex 2 wants cell banks “stored in the vapour phase of liquid nitrogen in sealed containers”, and then: “A stock inventory must be kept. The storage temperature should be recorded continuously and, where used, the liquid nitrogen level monitored.”11 FACT-JACIE is more specific: where products are not fully immersed, the device “shall have a system to monitor the temperature continuously and to record the temperature at least every four (4) hours”, alarms must be continuously active and reach staff on a 24-hour basis, activating “at a temperature or level of liquid nitrogen that will allow time to salvage products”, with a backup device ready.15

Cold alone is not the deliverable. Potency tests must be “specifically designed for each product”,16 and the FDA’s December 2023 draft guidance frames potency assurance across process design, process control, material control, in-process testing and lot release assays.17 A therapeutic bank is judged on what comes out of the tank.

Chain of identity, chain of custody

Two phrases do the work that barcodes only stand in for. FACT-JACIE defines chain of identity as “the permanent and transparent association of a cell or gene therapy’s unique identifiers from procurement of tissue or cells throughout the full product(s) lifecycle”, and chain of custody as “concurrent, permanent, auditable documentation illustrating the guardianship of a cell or gene therapy product from its origin through its final disposition”.15 Clinical programmes, apheresis facilities and processing facilities each need procedures allowing “tracking from the donor to the recipient or final disposition and tracing from the recipient or final disposition to the donor”.15

From apheresis to infusion, the bank is the middle

For an autologous therapy the starting material is a person, and the schedule is a patient’s. A 2025 review is blunt about the upstream end: “the quality and characteristics of the leukapheresis starting material has been identified as a potential root cause of manufacturing failure in autologous CAR-T cell products”.18 Downstream, the measure everyone watches is vein-to-vein time. Across the first twelve authorised French centres, 501 of 562 registrations for cytapheresis (89.1%) led to an infusion, and the median vein-to-vein time fell by four days — mainly by tightening apheresis to release — to 36 days, “compared to the 29-34 days reported in Canada, the USA and Israel”.19 Collection, cryopreservation, shipment, storage, release and return all sit between those two veins.

Cell banks and haplobanks: material drawn on for years

Allogeneic work turns the bank into the product’s memory. To stop properties drifting through repeated subculture, GMP asks that production be “based on a system of master and working virus seed lots and/or cell banks”: a master cell bank is an aliquot of a single pool of cells dispensed into many containers, from which all working cell banks derive, and both pass quarantine and release with documented “evidence of the stability and recovery of the seeds and banks”.11 The most ambitious version of the idea is the haplobank: one group reported a clinical-grade bank of 27 induced pluripotent stem cell lines from seven donors homozygous for the HLA types involved in immunorejection, made under good manufacturing practice from peripheral or umbilical cord blood and matching approximately 40% of the Japanese population.20 One therapeutic biobank can be the input to the next.

Consent, data, and the person the sample came from

The WMA Declaration of Taipei, adopted in 2002 and revised in 2016, treats a biobank as “a collection of biological material and associated data” and asks that donors be told the purpose, the risks, the data collected, the rules of access, how privacy is protected and who governs the collection; consent for indefinite multiple uses must be “specific, free and informed”, and donors may “at any time and without reprisal” alter it or ask for their material to be withdrawn.21 In a therapeutic bank that right meets a 30-year traceability duty and a donor-eligibility file that cannot simply be deleted.113 Reconciling the two is governance work, and it is usually harder than the freezers.

Who builds around a name like this

• Cell and gene therapy developers holding master and working cell banks and retained samples.11
• Hospital cell-processing laboratories, apheresis units and transplant programmes under FACT-JACIE or AABB standards.157
• Public and family cord blood banks, donor registries and the networks between them.34
• Cryogenic storage and cold-chain providers moving cryopreserved material between sites.1419
• Contract manufacturers and tissue establishments handling procurement, processing and release.1112
• Software for inventory, temperature records, labels, audit trails and chain of identity.1511

Biobank, biorepository, tissue bank, cell bank

ISBER lists biobank, biorepository, biological resource center, cryogenic biobank, tissue bank and cell bank among the alternative names for one kind of entity.2 Regulators use narrower words at the therapeutic end: HCT/P establishment in the United States, tissue establishment in Europe, SoHO establishment from 2027.81112 None of them is what a founder types into a browser. Therapeutic biobank is the phrase people use for banked biological material intended for patients, and TherapeuticBiobank.com is the exact .com for it.

TherapeuticBiobank.com is a domain name offered for sale by its owner. It is not affiliated with any regulator, standards body, registry or publisher named here; sources are cited as background only. This is a domain sale page. It does not provide medical advice or services.

1. ISO 20387:2018 Biotechnology — Biobanking — General requirements for biobanking.International Organization for Standardization, first edition 2018
2. Best Practices: Recommendations for Repositories, Fifth Edition.ISBER, 2023
3. Cord Blood Banking — Information for Consumers.U.S. Food and Drug Administration
4. About us, and the Search & Match Service.World Marrow Donor Association
5. About Us.NMDP, formerly the National Marrow Donor Program and Be The Match
6. FACT Standards: cellular therapy, immune effector cells and cord blood.Foundation for the Accreditation of Cellular Therapy, with JACIE and NetCord
7. Standards for Cellular Therapy Services, 12th edition.AABB; effective 1 July 2025
8. 21 CFR Part 1271: Human Cells, Tissues, and Cellular and Tissue-Based Products.Electronic Code of Federal Regulations; see 1271.1, 1271.3 and 1271.10
9. Regulatory Considerations for HCT/Ps: Minimal Manipulation and Homologous Use.U.S. Food and Drug Administration, guidance, July 2020
10. Directive 2004/23/EC on standards of quality and safety for human tissues and cells.European Parliament and Council, 31 March 2004
11. EudraLex Volume 4, Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use.European Commission; in operation 26 June 2018
12. Regulation (EU) 2024/1938 on substances of human origin intended for human application.European Parliament and Council, 2024
13. New regulation on substances of human origin: in force 7 August 2024, applies from 7 August 2027.Fimea, Finnish Medicines Agency
14. Dobruskin M et al. Optimizing cryopreservation strategies for scalable cell therapies.Biotechnology Progress, 2024
15. FACT-JACIE International Standards for Hematopoietic Cellular Therapy, Eighth Edition.FACT and JACIE, hosted by EBMT; glossary and standards B4.11, C4.11, D4.11, D9
16. 21 CFR 610.10: Potency.Electronic Code of Federal Regulations
17. Potency Assurance for Cellular and Gene Therapy Products.U.S. Food and Drug Administration, draft guidance, December 2023
18. Vega-Blanco B et al. Advancing CAR-T cell therapy: insights into patient biology, leukapheresis, and cryopreservation.Molecular Therapy, 2025
19. Schwiertz V et al. The French experience of pharmacists and CAR T-cells.Hematological Oncology, 2025
20. Yoshida S et al. A clinical-grade HLA haplobank of human induced pluripotent stem cells.Med, 2023
21. WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks.World Medical Association, adopted 2002, revised 2016