GMP-Compliant · FDA DMF Available

The clinical-grade
human platelet lysate
your cell therapy
deserves.

Pooled hPL from 200+ AABB-approved U.S. donors. Heparin-free, xeno-free, fibrinogen-depleted — and a proven replacement for FBS in MSC, CAR-T, NK and stem cell expansion.

200+
U.S. donors pooled
100%
FDA / AABB approved
0
Heparin · Xeno · Fibrinogen
Global
Clinical trial use
Compliance & quality FDA DMF on file AABB Accredited Sources GMP Compliant CoA Included Xeno-Free
What is hPL

The gold-standard supplement for regenerative medicine.

Human platelet lysate (hPL) is the cell culture supplement that finally delivers what fetal bovine serum can't: human-derived signaling, regulatory clarity, and consistent batch behavior — at concentrations as low as 2%.

Human platelets play an essential role in wound healing, tissue repair, inflammation, immunity and angiogenesis. When carefully lysed, their granules release a dense cocktail of growth factors, cytokines, adhesion molecules and bioavailable vitamins — exactly the signaling environment human cells expect.

Elk's pooled hPL is manufactured from FDA/AABB-approved apheresis platelet units, pooled across 200+ U.S. donors to minimize lot-to-lot variability. It is fibrinogen-depleted, so no heparin is required for use, and supplied with a Certificate of Analysis on every order.

Researchers see faster doubling times, lower supplement concentration, and a regulatory path that fetal bovine serum simply cannot offer.

2–10%
Typical use concentration
200+
Donors pooled per lot
4
Bottle volumes (25–500 mL)
0
Heparin / xeno proteins
Side by side

hPL vs FBS vs AB Serum

Why teams developing MSC, CAR-T and stem-cell therapies are migrating off animal-derived serum. Lower concentration, human origin, regulatory documentation — and a more reliable supply.

Parameter Elk Pooled hPL Fetal Bovine Serum (FBS) Human AB Serum
Origin Bovine fetus Human (single donor lots)
Xeno-free ✗ No ✓ Yes
GMP / FDA DMF Varies by supplier Varies by supplier
Typical use concentration 10–20% 5–10%
Bovine pathogen / prion risk Documented risk None
Lot-to-lot variability High High (single donor)
Heparin required — Often required
Cost-effectiveness at scale Moderate Low
Clinical trial use Limited (regulatory friction) Limited supply

Want the full technical comparison and protocol data? Request the spec sheet →

Why Elk hPL

Built for cell therapy manufacturing.

Every parameter — from donor sourcing to bottle format — is engineered for teams scaling from research to clinical manufacturing. Not a generic supplement repackaged.

01

GMP & FDA DMF

Manufactured under GMP with an FDA Drug Master File on record — referenceable in your IND, ready for clinical translation.

02

Pooled for consistency

200+ U.S. donors pooled per lot reduces variability that would otherwise compromise your assay reproducibility.

03

Faster cell kinetics

Higher doubling rates and improved viability for MSCs, CAR-T, NK and primary human cells — at 2–10% supplementation.

04

Heparin-free, fibrinogen-depleted

Our process removes fibrinogen — no clotting, no heparin supplementation, no extra optimization steps in your workflow.

05

Formats that fit

Bottles for manufacturing protocols (25 / 100 / 250 / 500 mL) and closed-system cryobags (250 / 500 mL) for bioreactors.

06

Dependable supply

Established supply partnerships and stable pricing — so commercial-scale planning doesn't depend on guesswork.

Applications

Where Elk hPL performs.

Used by cell therapy developers, regenerative medicine labs and contract manufacturers across four continents — at every stage from discovery to commercial GMP.

01 · MSC

Mesenchymal stromal cells

Ex vivo expansion of bone marrow, adipose and umbilical-derived MSCs with preserved tri-lineage potential.

02 · Immune

CAR-T, NK & T cells

Robust expansion of T-cells and NK cells without xenogenic protein contamination — direct fit for autologous and allogeneic programs.

03 · Endothelial

Endothelial cells

Sustains EC propagation for vascular research and tissue-engineering applications without bovine carryover.

04 · iPSC / ESC

Pluripotent & stem cells

Suitable for iPSC and stem cell programs where xeno-free, regulatory-compliant supplements are mandatory.

Formats

Bottles for protocols. Cryobags for scale.

Two product lines, both manufactured to identical specifications. Choose by workflow — both ship with CoA and FDA DMF reference letter on request.

Bottle Format

Pooled hPL Nalgene Bottles

GMP-ready human platelet lysate in Nalgene bottles — optimized for incorporation into established manufacturing protocols and benchtop expansion.

Available volumes
100 mL 250 mL 500 mL
Best for: protocol incorporation, R&D labs, mid-scale GMP manufacturing.
Request Bottle Quote
Cryobag Format

Pooled hPL Closed-System Cryobags

GMP-ready cryobags for automated clinical protocols and large-scale bioreactor manufacturing. Designed for closed-system sterile transfer.

Available volumes
250 mL 500 mL
Best for: automated clinical protocols, bioreactors, commercial-scale GMP.
Request Cryobag Quote
Talk to us

Request a quote.

Tell us your application and we'll respond within one business day with pricing, lead time, and a Certificate of Analysis from the most recent lot.

  • Response within 1 business day
  • CoA + FDA DMF reference letter on request
  • Volume pricing for commercial-scale needs
  • Global shipping (US, EU, UK, APAC)

By submitting, you agree to be contacted by Elk Bioscience. We never share your data.

Frequently asked

Answers, before you ask.

If you need anything more technical — CoA, DMF reference letter, growth-factor profiles, donor screening details — just request it in the form above.

hPL is a cell culture media supplement manufactured from human platelets. When platelets are lysed, their granules release growth factors, cytokines and adhesion molecules that strongly support the ex vivo expansion of human cells. Elk's hPL is pooled from 200+ U.S. donors and processed to be fibrinogen-depleted and heparin-free.
Yes. Our hPL is GMP-compliant and we have a Drug Master File (DMF) on record with the FDA that is referenceable for your IND submissions. Elk hPL has been used in clinical trials around the globe.
No. Heparin is not required because our hPL is fibrinogen-depleted during processing, eliminating plasmatic coagulation factors that would otherwise cause clotting. No additional heparin supplementation is needed.
hPL is generally suitable at 2–10%, lower than the 10–20% typically required for FBS or AB serum, because it is rich in growth factors and cytokines. MSCs typically work well at 5%, while CAR-T and NK cell protocols may use 2–5%. Optimal concentration should always be validated for your specific application.
Yes. All platelets come from FDA/AABB-approved blood centers. Donors are tested and found negative for HIV I/II antibody, HIV NAT, HTLV I/II antibody, Hepatitis B surface antigen and core antibody, Hepatitis C antibody and NAT, and RPR for Syphilis.
Yes — every Elk product ships with a CoA containing all release criteria, data and lot information. The CoA is provided upon purchase and is available for review before commitment on request.
Multiple freeze/thaw cycles do not significantly harm performance, but we recommend minimizing them. Upon initial thaw, aliquot into your working volumes and re-freeze at -20°C or -80°C for long-term storage.
Lead time and shipping logistics depend on volume, format and destination. We ship globally (US, EU, UK and APAC) under controlled cold-chain conditions. Request a quote and we'll confirm lead time for your specific order within one business day.

Move your cell therapy forward.

Get a quote or just a conversation with our scientific team. We respond within one business day.

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