Description
Product Overview
SeamlessBio Human Serum Type AB, Male Donors, Off-the-Clot is collected exclusively from healthy male AB donors at FDA-registered and EMA-compliant collection centres in the EU and USA. Natural coagulation without anticoagulants (off-the-clot) preserves the full native spectrum of growth factors — PDGF, EGF, TGF-β, IGF-1 — released during platelet degranulation, delivering the highest physiological potency available in human serum.
As a xeno-free, human-specific alternative to FBS, this serum is the preferred ancillary material for CAR-T expansion, NK cell therapy, MSC culture, ATMP manufacturing, vaccine development, and IVD assay development. Pooled from 200–250 donors per lot for maximum batch consistency. Explore the full Human Sera & Biomaterials Portfolio or read our guide on What is Human AB Serum?
Technical Specifications
| Parameter | Specification |
|---|---|
| Product type | Human serum, off-the-clot (OTC) |
| Blood group | AB — no anti-A or anti-B antibodies |
| Donors | Male only — eliminates hormonal variability and TRALI risk |
| Origin | EU and/or USA (per lot) |
| Collection centres | FDA-registered / EMA-compliant |
| Pool size | 200–250 donors per lot |
| Sterility | 0.1–0.2 µm sterile filtered |
| Mycoplasma | Negative (tested) |
| Virus testing | HIV-1/2 Ag/Ab, HBsAg, anti-HCV, syphilis, NAT |
| Heat inactivation | Available on request (56 °C, 30 min) |
| Gamma irradiation | Available on request (25–45 kGy) |
| Storage | –20 °C (long-term); +2 to +8 °C after thawing (stable 30 days) |
| Formats | 50 mL, 100 mL; bulk on request |
| Regulatory | Research Use Only (RUO); GMP documentation package on request |
Applications
| Application | Role of Human Serum AB (Male, OTC) |
|---|---|
| CAR-T cell expansion & activation | Xeno-free, growth factor-rich supplement for ex vivo T cell expansion — replaces FBS without bovine cross-reactivities. Compatible with GMP-adjacent protocols under Ph. Eur. 5.2.12. |
| NK cell expansion | Supports feeder-free NK cell expansion in haematopoietic systems — high native growth factor content (PDGF, EGF, TGF-β, IGF-1) drives proliferation without xenogenic contamination. |
| MSC culture (adipose, bone marrow) | Human-specific supplement for mesenchymal stem cell isolation, expansion, and characterisation — eliminates FBS-related lot variability in MSC proliferation and differentiation assays. |
| ATMP manufacturing (ancillary material) | Lot-specific documentation compliant with Ph. Eur. 5.2.12 and EudraLex Vol. 4, Part IV; GMP documentation package available on request. |
| Vaccine development | Human-specific growth factors and antibody-free AB matrix for neutralisation assays, immune cell culture, and human pathogen models (influenza, RSV, SARS-CoV-2). |
| Tissue engineering | Xeno-free supplement for primary keratinocytes, fibroblasts, chondrocytes, and limbal stem cells in skin, cartilage, and corneal tissue constructs. |
| IVD assay development | Physiologically relevant sample matrix for ELISA kits, immunoassays, and lateral flow development — AB blood group eliminates anti-A/anti-B interference; ISO 13485 / IVDR 2017/746 documentation available. |
| Malaria & infectious disease research | Standard supplement for Plasmodium falciparum culture — AB specificity prevents blood-group-specific lysis; complete virus testing protocols for BSL-2 handling. |
Off-the-Clot vs. Plasma-Derived Human Serum
| Property | Off-the-Clot (this product) | Plasma-Derived |
|---|---|---|
| Growth factors | ✔ High — native platelet degranulation (PDGF, EGF, TGF-β, IGF-1) | Moderate — CaCl₂ conversion |
| Best for | CAR-T, NK cells, MSC, tissue engineering | Assay development, diagnostics |
| Donors per lot | 200–250 (high consistency) | Variable |
| Complement activity | Present (heat inactivation available) | Present (heat inactivation available) |
Why Male Donors Only?
Female donors have cyclically fluctuating oestradiol and progesterone levels that influence cell proliferation, differentiation, and gene expression — introducing confounding variability in reproducibility-critical workflows. Exclusively male donor pools eliminate this hormonal variability. Additionally, previously pregnant female donors may carry anti-MHC antibodies (TRALI risk), which are absent in male-only pools.
Documentation Included Per Lot
- Certificate of Analysis (CoA) — lot-specific
- Virus testing protocols (HIV-1/2, HBV, HCV, syphilis, NAT)
- Sterility and mycoplasma test protocol
- Origin and collection centre certificate
- Safety Data Sheet (SDS)
- GMP documentation package (CoA, virus validation reports, donor certificates, Ph. Eur. 5.2.12 compliance declaration) — on request
Available Formats
| Format | Size |
|---|---|
| Bottle | 50 mL |
| Bottle | 100 mL |
| Bulk | On request from 1 L |
Key Benefits
Batch Reservation
Reserve validated lots up to 36 months for reproducible long-term workflows.
Full Documentation
CoA, virus testing protocols, sterility and mycoplasma data — from ISO 9001 and ISO 13485 certified partner facilities. GMP package on request.
EU & Swiss Supply
Sourced from certified EU and Swiss partner facilities — fast cold-chain delivery across EU, UK and Switzerland.
Frequently Asked Questions
What is Human Serum Type AB Male Off-the-Clot and why is it preferred over FBS for cell therapy?
Human Serum Type AB Male Off-the-Clot is collected from healthy male AB donors via natural coagulation without anticoagulants, preserving the full native platelet-released growth factor spectrum (PDGF, EGF, TGF-β, IGF-1). Unlike FBS, it is xeno-free — no bovine antigens — making it compliant with EMA/410/01 for human cell culture. The AB blood group eliminates anti-A/anti-B antibody interference, and male-only donors remove hormonal variability and TRALI risk. For CAR-T, NK cell, and MSC expansion, this is the physiologically correct and regulatory-preferred serum supplement.
Is this product suitable for GMP ATMP manufacturing?
The standard product is supplied as RUO (Research Use Only). For GMP applications — Phase I/II trials, ATMP manufacturing under EU Regulation 1394/2007 — a GMP documentation package is available on request, including lot-specific CoA, virus validation reports, collection centre certificates, and a Ph. Eur. 5.2.12 compliance declaration. Contact our team to discuss your specific documentation requirements.
What concentration is recommended and how do I switch from FBS?
Standard working concentration is 5–20% in cell culture medium. CAR-T and NK cell protocols typically use 2–10%. For adaptation from FBS: Week 1 — 5% FBS + 5% Human Serum AB; Week 2 onwards — 100% Human Serum AB. Stepwise reduction minimises adaptation stress and maintains viability above 90% throughout transition.
Is heat inactivation or gamma irradiation available?
Yes — both options are available on request. Heat inactivation (56 °C, 30 min) inactivates complement for complement-sensitive applications such as haematopoietic cell culture and immunoassays. Gamma irradiation (25–45 kGy) provides maximum viral safety for ATMP processes. Both treatments are performed at certified facilities and documented in the lot CoA.
How should the serum be stored after thawing, and can it be refrozen?
After thawing, store at +2 to +8 °C. Thawed serum is stable for 30 days. Do not refreeze — repeated freeze-thaw cycles degrade growth factors and reduce biological activity. We recommend aliquoting into single-use volumes before first use. Turbidity after thawing is normal (lipid precipitation) and does not affect quality; it clears on warming to room temperature.
Request a Quote, Sample, or GMP Documentation
48h response · EU & Swiss Supply · Batch reservation available · Full documentation
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