Human Platelet Lysate (hPL) — Xeno-Free FBS Alternative for MSC & Cell Therapy
EU-origin Human Platelet Lysate for mesenchymal stromal cell (MSC) expansion, ATMP manufacturing and 3D cell culture. Research, GMP and GMP-clinical grades — fibrinogen-depleted, virus-inactivated options available. No minimum order.
Xeno-Free & FBS-Free
Replaces animal-derived FBS in MSC and primary cell culture. Eliminates bovine-origin risk; meets the xeno-free raw material standard required for ATMP and cell therapy products.
Three Quality Grades
Research, GMP and GMP-clinical grades — fibrinogen-depleted and virus-inactivated formats. Full lot documentation for every GMP batch. Pooled and single-donor lots available.
High Native Growth Factor Content
Lysed platelets release PDGF-AB, EGF, TGF-β1, VEGF, bFGF and IGF-1 directly into the supernatant — supporting robust MSC proliferation without recombinant supplement cocktails.
ATMP & Regulatory Ready
EU-certified donor centres. Aligned with EMA ATMP Reg EC 1394/2007, EU GMP Annex 2 (2023) and FDA 21 CFR Part 1271. GMP-clinical grade is virus-inactivated for maximum safety.
Designed For: MSC Labs, Cell Therapy CDMOs & ATMP Manufacturers
SeamlessBio supplies hPL to three primary customer groups: academic and translational MSC research labs switching from FBS; cell therapy CDMOs requiring GMP-grade xeno-free media for clinical-stage manufacturing; and ATMP manufacturers needing GMP-clinical-grade raw materials with full traceability and viral inactivation.
For ATMPs under EMA classification (EC 1394/2007) and cell-based products under FDA oversight, hPL must come with lot-specific CoA, SDS and traceability documentation. All GMP grades supplied by SeamlessBio include full batch documentation as standard.
SeamlessBio covers EU and UK supply. Batch reservation for production campaigns available.
Typical applications
- MSC expansion — bone marrow, adipose, umbilical cord-derived
- Allogeneic cell therapy upstream process development
- GMP manufacturing of MSC-based ATMPs
- Primary cell culture — fibroblasts, endothelial cells, keratinocytes
- Organoid and organ-on-a-chip cultivation
- 3D bioprinting — hPL as fibrinogen-based bioink / hydrogel matrix
- Diagnostic antigen production in primary human cells
- FBS replacement for clinical-stage process transfer
Human Platelet Lysate — Quality Grades
Three quality levels, fibrinogen-depleted and virus-inactivated formats — from cost-effective research grade to fully GMP-clinical certified supply with viral safety testing. All EU origin, certified donor centres.
hPL Quality Grade Overview
All grades EU-origin from regulated platelet collections. Fibrinogen-depleted (FD) formats are anticoagulant-free and clot-free — no heparin required.
| Grade | Format | Viral Inactivation | Application | Documentation |
|---|---|---|---|---|
| Research Grade | Standard · Fibrinogen-depleted (FD) | — | Academic research, assay development, diagnostics | CoA · SDS |
| GMP Grade | Fibrinogen-depleted (FD) · FD PLUS variants | Optional | Pre-clinical, translational, process development for cell therapy | CoA · SDS · Traceability · Lot release |
| GMP-Clinical Grade | Fibrinogen-depleted, virus-inactivated | Yes (validated) | ATMP manufacturing, clinical cell therapy, IMP production | Full GMP batch docs · Viral safety testing · CoA · SDS |
| 3D Matrix Kit | Fibrinogen-based hydrogel (hPL-derived) | — | 3D cell culture, bioprinting, organoids, tissue engineering | CoA · SDS |
Key Specifications
Native Growth Factor Content in hPL
Human Platelet Lysate delivers a broad spectrum of native growth factors released from lysed platelets — without the lot-to-lot variability and zoonotic risk of FBS.
Platelet-Derived Growth Factor
Key mitogen for MSC and fibroblast proliferation. Drives the superior expansion rates of MSCs in hPL vs. FBS cultures.
Epidermal Growth Factor
Supports epithelial and endothelial cell proliferation. Important for primary cell culture of keratinocytes and corneal cells.
Transforming Growth Factor β1
Regulates MSC differentiation and immunomodulatory function. Relevant for manufacturing of immunosuppressive MSC products.
Angiogenic & Survival Factors
Support endothelial cell culture, cell survival under serum-reduced conditions, and vascularisation in 3D tissue models.
Aligned With ATMP & Cell Therapy Regulatory Requirements
GMP and GMP-clinical grade hPL is manufactured and tested to meet the raw material expectations of the most demanding regulatory frameworks in cell and gene therapy.
EMA ATMP Regulation
EC 1394/2007. Xeno-free, human-derived raw materials with full donor traceability and batch documentation — required for ATMP GMP compliance.
EU GMP Annex 2 (2023)
Updated GMP requirements for advanced therapy medicinal products. GMP-clinical hPL includes viral inactivation validation to meet Annex 2 viral safety expectations.
FDA 21 CFR Part 1271
HCT/P and cell therapy upstream raw material requirements. EU-origin GMP supply chain with ISO documentation supports US IND and BLA submissions.
ICH Q5A — Viral Safety
GMP-clinical grade includes virus inactivation (validated process) and virus removal steps, addressing ICH Q5A requirements for human-derived raw materials.
EU-Origin hPL from a Regulated European Manufacturer
SeamlessBio supplies Human Platelet Lysate manufactured by a certified European specialist — exclusively focused on hPL production, with GMP-certified manufacturing infrastructure and an established track record in cell therapy supply chains. Our manufacturing partner operates under ISO 13485 and EU GMP, with certified European donor centres and validated viral inactivation processes for clinical-grade material.
SeamlessBio provides EU and UK customers with direct supply chain support, batch documentation assistance and technical consultation for process development and regulatory qualification.
EU supply chain active. Contact SeamlessBio for current lead times, available lot sizes and sample requests.
Request a free hPL sample or batch quote
Free test samples available for all grades. No minimum order. 48-hour quote turnaround. Contact us for lot-specific CoA, technical datasheets and pooled lot availability.
Contact UsFrequently Asked Questions — Human Platelet Lysate
What is Human Platelet Lysate (hPL) and why is it used instead of FBS?
Human Platelet Lysate (hPL) is a xeno-free, serum-free cell culture supplement derived from pooled human platelets. When platelets are lysed, they release a broad spectrum of native growth factors — PDGF-AB, EGF, TGF-β1, VEGF, bFGF and IGF-1 — directly into the supernatant. hPL supports comparable or superior proliferation of mesenchymal stromal/stem cells (MSCs) versus FBS, while eliminating all bovine-derived materials. This removes zoonotic risk and meets the xeno-free raw material standard required for ATMP and clinical cell therapy manufacturing under EMA and FDA guidelines.
What does fibrinogen-depleted mean, and do I still need heparin?
Standard hPL contains fibrinogen, which polymerises and forms clots in culture. To prevent this, heparin is traditionally added to the medium. Fibrinogen-depleted (FD) hPL has had the fibrinogen fraction removed during manufacturing — it is anticoagulant-free and clot-free, with no heparin required. This simplifies cell culture protocols, reduces formulation variability, and removes potential heparin-related interference in downstream analyses. All GMP-grade hPL available through SeamlessBio is available in fibrinogen-depleted format.
Is GMP-grade hPL available for ATMP and clinical manufacturing?
Yes. SeamlessBio supplies both GMP-grade and GMP-clinical-grade hPL from EU-certified donor centres. GMP-clinical grade is virus-inactivated (validated process) and supplied with full batch documentation — CoA, SDS, full traceability records, and viral safety testing documentation — aligned with EMA ATMP Regulation EC 1394/2007, EU GMP Annex 2 (2023), FDA 21 CFR Part 1271 and ICH Q5A requirements.
Which cell types and applications is hPL validated for?
Human Platelet Lysate is primarily validated for MSC expansion from bone marrow, adipose tissue and umbilical cord. It also supports primary human cells including fibroblasts, endothelial cells and keratinocytes. Additional applications include organoid culture, organ-on-a-chip systems and 3D bioprinting, where the fibrinogen component of non-depleted hPL or hPL-based matrix kits serves as a natural hydrogel scaffold. Contact SeamlessBio for cell-line-specific suitability data.
Is there a minimum order quantity?
No minimum order quantity. Free test samples are available for all quality grades for research and process development evaluation. Volume pricing, pooled lot reservations and batch reservation for GMP production campaigns are available on request — contact SeamlessBio.
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