Description
Human platelet lysate (hPL) from regulated EU platelet collections – the xeno-free replacement for fetal bovine serum in MSC and primary cell culture, ATMP manufacturing and 3D culture. Research, GMP and GMP-clinical grades.
Product Overview
FBS brings undefined animal components, lot-to-lot variability and regulatory risk into advanced therapy manufacturing. hPL is human-derived and xeno-free, and delivers native growth factors released from lysed platelets – PDGF-AB, EGF, TGF-β1, VEGF, bFGF and IGF-1 – supporting robust MSC proliferation without recombinant supplement cocktails.
Quality Grades
| Grade | Format | Use |
|---|---|---|
| Research | Standard · fibrinogen-depleted | Academic research, assay development |
| GMP | Fibrinogen-depleted | Pre-clinical and process development for cell therapy |
| GMP-Clinical | Fibrinogen-depleted, virus-inactivated | ATMP manufacturing, clinical cell therapy |
| 3D Matrix Kit | hPL-derived fibrinogen hydrogel | 3D culture, bioprinting, organoids |
Applications
- MSC expansion – bone marrow, adipose, umbilical cord
- Allogeneic cell therapy process development
- GMP manufacturing of MSC-based ATMPs
- Primary cell culture – fibroblasts, endothelial cells, keratinocytes
- Organoid and organ-on-a-chip culture
- FBS replacement for clinical-stage process transfer
Specifications
- Origin: EU platelet units from healthy donors, collected following European guidelines
- Fibrinogen-depleted formats: clot-free and heparin-free – no anticoagulant needed in cell culture or during manufacturing
- GMP-clinical grade: validated virus inactivation
- Documentation: CoA, SDS; GMP grades with traceability and lot release documents
- Regulatory alignment: EMA ATMP Regulation EC 1394/2007, EU GMP Annex 2
- Blood-bank format: hPL supplied directly from the blood bank in 250 mL blood bags – on request
- Minimum order: none · free test samples
GMP grade, fibrinogen-depleted – technical data
| Parameter | Specification |
|---|---|
| Format | Fibrinogen-depleted, heparin-free hPL; clot-free, ready to use |
| Animal components | None – xeno-free, human-derived |
| Origin and traceability | EU-origin platelet units; raw-material traceability for 30 years |
| Pack sizes | 50 mL, 100 mL, 500 mL |
| Storage | Frozen at −40 °C to −20 °C |
| Shelf life | 2 years from date of manufacture, stored frozen in the original bottle |
| Working concentration | 1–10 % (v/v) in basal medium (e.g. MEM α, DMEM); determine the optimum for your cell type |
| After thawing | Thawed hPL and complete medium stable for up to 7 days at 4 °C |
| Sterility | Aseptically processed; microbial cultures tested negative; QC testing in a certified test laboratory |
| Documentation | Certificate of Analysis and Safety Data Sheet |
| Intended use | Manufacturing use; not for direct administration to animals or humans, or therapeutic use |
Handling
- Thaw completely in a 37 °C water bath, or at room temperature if no water bath is available.
- Particles or turbidity may appear after thawing and do not affect cell culture performance; if needed, centrifuge the pure hPL at 3,400 × g for 3–5 minutes.
- Add hPL to the basal medium – no heparin needed.
- Aliquot and refreeze unused hPL after thawing; avoid repeated freeze–thaw cycles.
- Handle as a human blood-derived material according to standard biosafety practice.
Key Benefits
Batch Reservation
Reserve your lot for up to 36 months with free storage in EU cold stock – no prepayment.
Full Documentation
CoA and SDS with every lot; traceability documentation for GMP grades.
EU & Swiss Supply
Shipped from EU stock; Swiss customers are served by Seamless Bio GmbH in CHF.
Frequently Asked Questions
Why replace FBS with hPL?
hPL is xeno-free and human-derived, removes bovine-origin risk and is the preferred FBS alternative for ATMP manufacturing under EMA guidelines.
What does fibrinogen-depleted mean?
Standard hPL needs heparin to prevent clotting. Fibrinogen-depleted hPL has this fraction removed – no heparin, simpler handling, less variability.
Which grade do I need?
Research grade for academic work, GMP grade for process development, GMP-clinical grade (virus-inactivated) for clinical ATMP manufacturing.
Can I reserve a production lot?
Yes – batch reservation for production campaigns for up to 36 months, without prepayment.
Request a Quote or Sample
Tell us the grade, format and volume – we send documentation and a free test sample.
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