Human Serum Type AB Male Off-the-Clot — CAR-T, NK Cells, ATMP | SeamlessBio
Human Serum Type AB, Male Off-the-Clot — CAR-T, NK Cells & ATMP Gold Standard
Human Serum Type AB Male Off-the-Clot is the highest-specification human serum product — combining all three critical quality attributes for advanced cell therapy applications: the universal blood type (AB), male-only donors (no hormonal variability, no TRALI risk), and off-the-clot collection (maximum native growth factors from platelet degranulation).
This product is the industry reference standard for CAR-T and NK cell ex vivo expansion, ATMP manufacturing, and MSC expansion. It is specified by GMP manufacturing protocols, referenced in the literature for cell therapy workflows, and is the product for which Ph. Eur. 5.2.12 ancillary material documentation is most frequently requested.
The three attributes that make this the gold standard: Type AB — no anti-A/B antibodies that would lyse cells or interfere with assays. Male donors — no oestradiol/progesterone variability, no TRALI risk from anti-HLA antibodies. Off-the-Clot — maximum PDGF, EGF, TGF-β, IGF-1 from platelet degranulation during natural coagulation.
All Three Properties — Why Each Matters
| Property | What it eliminates | Impact |
|---|
| Type AB | Anti-A and anti-B antibodies | No blood-group-mediated cell lysis. Compatible with all cell types. Required for cells expressing A or B surface antigens. |
| Male donors only | Oestradiol, progesterone cycling. Anti-HLA antibodies. | Consistent lot performance. No hormone-driven variation in cell expansion or differentiation. No TRALI risk. |
| Off-the-Clot | Growth factor deficit from platelet removal | Full PDGF, EGF, TGF-β, IGF-1 spectrum. Maximum proliferative support for T cells, NK cells, MSCs. |
Primary Applications
| Application | Standard use | Documentation available |
|---|
| CAR-T cell ex vivo expansion | 2–10% in X-VIVO 15, AIM V, or TexMACS medium. Replaces FBS in T cell expansion protocols. | Ph. Eur. 5.2.12, Eudralex Vol. 4 Part IV, CoA, CoO, viral safety |
| NK cell expansion | 5–10% in IL-2/feeder or feeder-free NK expansion medium. Essential for peripheral blood NK cell protocols. | Same as above |
| MSC expansion (bone marrow, adipose, cord) | 5–10% in α-MEM or DMEM. Xeno-free alternative to FBS for MSC banking and clinical-grade expansion. | Ph. Eur. 5.2.12 available |
| ATMP manufacturing (Phase I/II) | Ancillary material for cell therapy IMP production. EMA/410/01 alignment. | Full GMP documentation package on request |
| Plasmodium falciparum culture | 5% in RPMI-1640. AB prevents RBC lysis; OTC provides growth factors for parasite maintenance. | Standard CoA + viral testing |
| Tissue engineering (skin, cartilage, cornea) | 5–10% for fibroblast, chondrocyte, limbal stem cell culture. Xeno-free prerequisite for clinical translation. | CoA, CoO |
| CRO immunology studies | 2–10% for cytotoxicity, MLR, cytokine assays. ISO 10993-5 compatible. | CoA, MSDS |
GMP Documentation Package
| Document | Content |
|---|
| Certificate of Analysis (CoA) | Purity, endotoxin (LAL), pH, sterility, blood type confirmation, viral marker testing results |
| Certificate of Origin (CoO) | Donor centre certification, collection country, collection conditions |
| Ph. Eur. 5.2.12 Declaration | Ancillary material compliance statement for ATMP applications |
| Eudralex Vol. 4 Part IV | GMP compliance for ATMP manufacturing ancillary materials |
| Viral safety declaration | Extended TSE/BSE-free statement (N/A for human serum — relevant for accompanying materials) |
| Single-donor lots | Available on request for HLA typing, pharmacokinetic, and metabolic studies |
Practical Protocol Notes
| Topic | Guidance |
|---|
| Recommended concentration | CAR-T/NK: 2–10%. MSC: 5–10%. General: 5–20%. Start low and adjust based on growth curves. |
| Switching from FBS | Stepwise adaptation: Week 1 — 50% FBS + 50% human serum. Week 2 — 100% human serum. Avoids osmotic shock. |
| Turbidity after thawing | Normal — lipid precipitation. Does not affect quality. Gently mix before use; do not centrifuge. |
| After thawing storage | +2 to +8 °C, stable for 30 days. Do not refreeze. Aliquot before first use. |
| Heat inactivation available | Yes — 56°C/30 min for complement-sensitive applications (haematopoietic cells, immunoassays) |
| Gamma irradiation available | Yes — 25–45 kGy for maximum viral safety in ATMP manufacturing |
Complete Human Serum Portfolio
| Product | Blood Type | Donor | Processing | Primary Use | Order |
|---|
| Human Serum | Mixed | Mixed | HI or GI | General cell culture, diagnostics | Shop → |
| Human Serum, Male | Mixed | Male only | HI or GI | Hormone-controlled cell culture | Shop → |
| Human Serum, Type AB | AB | Mixed | HI or GI | Immunoassays, diagnostics | Shop → |
| Human Serum Type AB, Male | AB | Male only | HI or GI | Cell therapy R&D, immune assays | Shop → |
| Human Serum Off-the-Clot | Mixed | Mixed | OTC | Growth factor-rich cell culture | Shop → |
| Human Serum Type AB, Off-the-Clot | AB | Mixed | OTC | Universal donor, growth factor-rich | Shop → |
| Human Serum Type AB, Male OTC | AB | Male only | OTC | CAR-T, NK cells, ATMP — gold standard | Shop → |
Order Human Serum AB Male OTC
Request GMP documentation or test volume
Contact: info@seamlessbio.de | +49 851 37932226
