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SeamlessBio — Human Plasma

Human Plasma — Pooled

Multi-donor pooled plasma from certified EU and US donor centres — EDTA, heparin and citrate formats. The standard bulk matrix for IVD calibrator manufacturing, coagulation assay development and large-scale diagnostic reagent production.

Human Plasma Pooled — SeamlessBio
01

EU & US Origin

Collected at certified donor banks in the EU and USA — fully documented and traceable per batch. Specify origin at order.

02

3 Anticoagulant Formats

EDTA, heparin and citrate available — ACD-A on request. Specify the format required for your assay system.

03

No Minimum Order

From 500 mL evaluation volumes to multi-litre bulk lots — same documentation at every scale. Batch reservation available.

04

Full Viral & Batch Documentation

HIV, HBsAg, HCV and syphilis screened per lot. CoA, CoO and MSDS included. NAT screening available on request.

The right anticoagulant format for your application

Pooled human plasma is the standard bulk matrix for IVD calibrator and control manufacturing — providing a homogeneous, large-volume source with stable protein concentrations and minimised lot-to-lot variation. The most common decision when ordering is anticoagulant format.

EDTA plasma is the reference format for most immunoassay and clinical chemistry applications. EDTA irreversibly chelates calcium and magnesium, preventing coagulation while stabilising cell morphology. Use for ELISA calibrators, lateral flow development, and general IVD matrix applications.

Citrate plasma reversibly chelates calcium — coagulation activity can be restored by re-adding calcium chloride. Required for PT, APTT, fibrinogen and factor activity assays. Not interchangeable with EDTA for coagulation work.

Heparin plasma inhibits thrombin without chelation. Used in some cell culture and emergency chemistry protocols — note that heparin can interfere with PCR-based assays. Confirm compatibility before specifying.

Not sure which format fits your protocol? Contact us — we advise on format selection at no charge.

Typical applications

  • IVD calibrator and control manufacturing (EDTA, citrate)
  • Coagulation assay development — PT, APTT, fibrinogen, factor activity (citrate)
  • ELISA and lateral flow assay matrix development
  • Clinical chemistry assay validation across a pooled donor matrix
  • Plasma protein binding and pharmacokinetics studies
  • Reference standard and working standard production
  • Process development using outdated plasma (HP-out)
  • Large-scale reagent manufacturing — bulk lots ≥2 L

Product specifications

Article numberHPPool
Product typeHuman Plasma, Pooled — Multi-Donor
OriginEU or US — specify at order
AnticoagulantEDTA (K2 or K3) · Heparin (Li or Na) · Citrate (3.2% or 3.8%) · ACD-A on request
Donor pool sizeTypically ≥20 donors per lot — custom pool size on request
Blood typeMixed pool standard · AB pool on request
Donor genderMixed standard · Male-only pool on request
StorageFresh-frozen −20°C standard · −80°C on request
Viral screeningHIV-1/2 Ab, HBsAg, HCV Ab, Syphilis — all negative per lot
NAT screeningAvailable on request (HIV-1 RNA, HCV RNA, HBV DNA)
Available volumes500 mL · 1 L standard · 2 L–10 L+ bulk on request
DocumentationCoA, CoO, MSDS, Viral Screening Report — included
Minimum orderNo minimum order quantity
Regulatory statusFor research and IVD manufacturing use

Frequently asked questions

How many donors are in a standard pooled lot?

Typically ≥20 pre-screened donors per lot. A larger pool stabilises average protein concentrations and reduces inter-lot variability — important for IVD calibrator matrices where lot-to-lot consistency is a regulatory requirement. Custom pool sizes are available on request.

Can I reserve a lot before committing to the full volume?

Yes. SeamlessBio holds reserved lots in EU cold stock with no prepayment required during the evaluation period — up to 6 weeks as standard. A forced mid-production lot change for IVD calibrators typically costs €20,000–50,000 in comparability testing and change control. Reserving your full programme lifecycle requirement from the start avoids this entirely.

Is NAT screening available?

Yes. Standard lots include serological screening. NAT screening (HIV-1 RNA, HCV RNA, HBV DNA by PCR) is available on selected lots or can be commissioned. State your NAT requirement at enquiry — availability and lead time vary by lot.

Is outdated plasma available for process development?

Yes — outdated plasma (HP-out) from certified EU centres is available at reduced cost for manufacturing trials and equipment qualification where final analytical performance is not critical. Viral screening data is included. Contact us for current availability.

Not sure which plasma format fits your protocol?

Contact our team — we advise on anticoagulant format, lot size and origin, and provide a free test volume before you commit.

Contact Us

Need a Lot Reservation or Test Sample?

Reserve your validated FBS or human serum lot — no prepayment.
Free test samples on request.

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