Human Serum in Single-Use Bags — All Variants · cGMP · ISO 13485
Human Serum in GMP-compatible closed-system single-use bags — all variants from Mixed Gender to Type AB Male Off-the-Clot. 250 mL to 5 L. EU and US origin. Gamma irradiated on request. Full ATMP ancillary material documentation. Lot reservation without prepayment. EU supplier.
Available Variants in Single-Use Bags
All Human Serum variants available in single-use bags on request. Contact us with your variant, volume and documentation requirements.
| Variant | Best For | Key Properties | Bag Sizes |
|---|---|---|---|
| Human Serum Mixed Gender | IVD calibrators, general cell culture | Pooled, heat inactivated or gamma irradiated | 250 mL – 5 L |
| Human Serum Male | MLR, ELISPOT, T-cell assays | HLA alloantibody-free, male donors only | 250 mL – 5 L |
| Human Serum Type AB | Immunoassays, no anti-A/B interference | AB blood group, pooled | 250 mL – 5 L |
| Human Serum Type AB Male | CAR-T expansion, ATMP manufacturing | AB + male — no anti-A/B, no HLA alloantibodies | 250 mL – 5 L |
| Human Serum OTC | MSC, organoids, stem cells | Off-the-Clot — maximum native growth factors | 250 mL – 5 L |
| Human Serum OTC AB Male | CAR-T, NK cells, ATMP GMP-adjacent | OTC + AB + Male — highest growth factors, xeno-free | 250 mL – 5 L |
| Human Serum Heat Inactivated | Hybridoma, complement-sensitive cells | 56°C/30 min complement inactivation | 250 mL – 2 L |
| Human Serum Gamma Irradiated | ATMP, maximum viral safety | 25–45 kGy gamma irradiation | 250 mL – 5 L |
Custom variants and processing (heat inactivation + gamma irradiation combined, specific donor pools, single-donor lots) available on request.
Why Single-Use Bags for Cell Therapy?
Closed-System Processing
Single-use bags with weldable tubing enable fully closed handling — no open bottle manipulation, no pipette transfer, no contamination risk. Direct welding to bioreactor assemblies and media bags for end-to-end closed processes.
Regulatory Compliance
EMA and FDA increasingly require closed systems for ATMP manufacturing. Single-use bags support compliance with EU GMP Annex 1 (contamination prevention), Eudralex Vol. 4 Part IV (ATMPs) and FDA 21 CFR 1271 (HCT/Ps).
Process Integration
Bags integrate directly into G-Rex, WAVE and stirred-tank bioreactor workflows. Eliminates the bottle-opening step that introduces contamination risk at the most critical point — media supplementation in GMP manufacturing.
Scalability
From 250 mL for early process development to 5 L for commercial-scale CAR-T and NK cell manufacturing. Single bag volume matches typical bioreactor batch size — no pooling of multiple small bottles required.
EU Origin — Shorter Lead Times
SeamlessBio is based in Passau, Germany. EU origin human serum — no import/export delays, no customs clearance, full cold-chain within Europe. Typical lead time 5–10 business days vs. 3–6 weeks from US suppliers.
Lot Reservation
Reserve your validated lot for up to 12 months without prepayment. Call off in partial deliveries. Critical for multi-year clinical trials where lot consistency is a regulatory requirement.
Product Specifications
| Human Serum Type AB Male OTC — Single-Use Bag | |
|---|---|
| Donor Type | Type AB Male — no anti-A/B antibodies |
| Collection Method | Off-the-Clot — maximum native growth factors |
| Origin | EU and/or US (certified, traceable donor centres) |
| Filtration | 0.2 µm sterile filtered (0.1 µm on request) |
| Gamma Irradiation | 25–45 kGy on request |
| Heat Inactivation | 56°C/30 min on request |
| Mycoplasma | Negative (PCR + culture method) |
| Endotoxin | ≤5 EU/mL (LAL) |
| Viral Testing | HIV-1/2, HBsAg, anti-HCV, syphilis, NAT |
| Storage | -20°C (long-term) / -80°C on request |
| Shelf Life | 24 months from date of manufacture |
| Quality System | cGMP Quality · ISO 13485 Certified |
| Bag Formats & Volumes | |
|---|---|
| 250 mL bag | Standard — process development, small batches |
| 500 mL bag | G-Rex 6M compatible (5% supplementation = 25 mL) |
| 1 L bag | G-Rex 10M / clinical batch scale |
| 2 L bag | Commercial scale batches |
| 5 L bag | Large-scale commercial CAR-T/NK manufacturing |
| Tubing | Standard · Weldable on request |
| Sampling ports | On request |
| Material | USP Class VI compliant |
| Custom volumes | On request (MOQ applies) |
| Availability | |
| Lead time | 5–10 business days (EU) · Faster from stock |
| Lot reservation | Up to 12 months — no prepayment |
| Test sample | Free — available on request |
SeamlessBio vs US Suppliers — Key Differences
| Parameter | SeamlessBio (EU) | US Suppliers (Akron, GeminiBio, R&D Systems) |
|---|---|---|
| Origin | EU and/or US donors | US donors only |
| EU Regulatory Docs | EMA/410/01 · EU donor screening ✅ | FDA-focused · EMA docs limited |
| Lead Time to DACH/EU | 5–10 business days ✅ | 3–6 weeks (import + customs) |
| Cold Chain | EU cold-chain network ✅ | International dry ice shipment |
| Lot Reservation | 12 months, no prepayment ✅ | Typically 30–90 days |
| Min. Order | No minimum order ✅ | Often case quantities |
| Free Test Sample | Yes ✅ | Limited / quote required |
| Language Support | DE / EN ✅ | EN only |
| Bag Sizes | 250 mL – 5 L ✅ | 50 mL – 100 mL (R&D Systems) / custom (Akron) |
Applications
CAR-T Cell Manufacturing
Human Serum AB Male OTC is the standard ancillary material for ex vivo T-cell expansion in CAR-T manufacturing. Bag format integrates directly into G-Rex and stirred-tank bioreactor closed-system workflows. EMA/410/01 xeno-free compliant. Ph. Eur. 5.2.12 documentation package on request.
NK Cell Expansion
Type AB — no anti-A/B antibodies. No HLA alloantibodies from male donors. Optimal for NK cell expansion where immune reactivity must be minimised. Gamma irradiated (25–45 kGy) option for maximum viral safety in ATMP processes.
MSC Expansion (Research)
Human Serum OTC provides maximum native growth factors for mesenchymal stromal cell expansion. Bag format for GMP-adjacent MSC manufacturing processes. For fully xeno-free GMP MSC manufacturing, consider Human Platelet Lysate (hPL).
iPSC & Primary Cell Culture
Type AB xeno-free serum for defined human primary cell workflows. No bovine antigens. Compatible with EMA guidance for clinical-stage cell therapy development where FBS must be eliminated.
Regulatory Documentation
Standard (per lot)
- Certificate of Analysis (CoA)
- Certificate of Origin (CoO)
- TSE/BSE Statement
- Donor Screening Records
- Sterility Testing (USP <71>)
- Mycoplasma Testing
- Endotoxin (LAL)
- Safety Data Sheet (SDS)
ATMP Package (on request)
- ISO 13485 Certificate
- Ph. Eur. 5.2.12 Documentation
- Eudralex Vol. 4 Part IV Support
- Regulatory Support File (RSF)
- Extended Viral Testing Panel
- Ancillary Material Risk Assessment
- EMA/410/01 Compliance Statement
Supply Security
- Lot reservation 12 months
- No prepayment required
- Call off in partial deliveries
- EU cold-chain logistics
- Free test sample before commitment
- Dedicated account manager
- 48-hour quote response
Frequently Asked Questions
What volumes are available?
250 mL, 500 mL, 1 L, 2 L and 5 L single-use bags. Custom volumes on request. All on request — contact info@seamlessbio.de.
Why use single-use bags instead of bottles?
Bags enable closed-system processing — direct welding to bioreactor assemblies, no open bottle manipulation, no contamination risk. Required for GMP-compliant CAR-T and NK cell manufacturing under EMA and FDA guidance.
Is gamma irradiation available?
Yes — 25–45 kGy gamma irradiation on request. Provides maximum viral safety for ATMP processes. Standard: 0.2 µm sterile filtered. Heat inactivation (56°C/30 min) also available.
What is the advantage of EU origin vs US suppliers?
Shorter lead times (5–10 days vs 3–6 weeks), no import delays, EU cold-chain logistics, EMA/410/01 compliant EU donor documentation, German-language support, no minimum order, 12-month lot reservation without prepayment.
Can I get a free test sample?
Yes — free test samples available before commitment. Request via info@seamlessbio.de or +49 851 37932226.
Related Products
Human Serum AB Male OTC — Bottles
100 mL and 500 mL bottles for research and process development.
HSA Cell Culture Grade
5% and 20% solutions for cell washing and cryopreservation.
Human Platelet Lysate (hPL)
Fully xeno-free GMP alternative for MSC expansion.
Cell Therapy & ATMPs
Complete ATMP raw materials overview and workflow guide.
Request Human Serum in Single-Use Bags
Free test sample · cGMP · ISO 13485 · EU origin · 250 mL – 5 L · Lot reservation 12 months · No prepayment · 48-hour response
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