Human Serum & Plasma for IVD, CRO & Bioanalytical Applications — EU Delivery

The right human matrix makes or breaks your assay. SeamlessBio supplies Human Serum Type AB and Human Plasma (citrate, apheresis) from EU-sourced, fully documented donors — for matrix matching, assay validation, calibrator preparation, and method development. No minimum order, same-week delivery across the EU.

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Order human serum and plasma from our EU stock

Request a quote or a free test sample – EU stock, no minimum order, lot reservation up to 36 months.

Serum or Plasma — Which Do You Need?

The choice between serum and plasma depends entirely on your assay type and regulatory requirements. Using the wrong matrix introduces systematic error that cannot be corrected downstream.

Application	Use Serum	Use Plasma
Immunoassay / ELISA (antibodies, hormones, tumour markers)	✓ Preferred	Possible, check kit
Serology (HIV, Hepatitis, syphilis)	✓ Preferred	—
IVD calibrator & control matrix matching	✓ Standard	For coagulation kits
Drug level assays (PK/TDM)	✓ Preferred	Possible (heparin-plasma)
Matrix effect validation (FDA/EMA bioanalytical guidance)	✓ Six individual lots	✓ Six individual lots
Coagulation assays (PT, aPTT, fibrinogen)	—	✓ Citrate plasma required
Biomarker discovery / proteomics	—	✓ EDTA or citrate plasma
Cell culture supplement / conditioned media	✓ Human AB Serum	—

Human Serum Type AB — Specifications

Pooled from male AB-type donors — the universal serum matrix for immunoassay development and cell culture applications requiring a human matrix without ABO antibody interference.

Specification	Detail
Blood group	Type AB, male donors
Source	EU-sourced, fully traceable donor documentation
Sterility	Sterile filtered (0.2 µm); tested negative for HBsAg, HCV, HIV-1/2, syphilis
Haemolysis	< 20 mg/dL haemoglobin (non-haemolytic grade)
Format	From 1 mL to bulk; pooled or individual donor lots available on request
Storage	−20 °C; shipped on dry ice
Documentation	CoA, donor screening report, lot-specific data on request

Human Plasma — Citrate & Apheresis

Citrate-anticoagulated human plasma from apheresis donors — for coagulation assay development, biomarker studies, and applications requiring intact clotting factors.

Specification	Detail
Anticoagulant	Sodium citrate (3.2 %); EDTA available on request
Collection method	Apheresis — higher volume per donor, reduced lot variability
Source	EU-sourced (Poland); fully traceable
Sterility	Sterile filtered; tested for HBsAg, HCV, HIV-1/2
Clotting factors	Intact — suitable for PT, aPTT, fibrinogen, FVIII assays
Format	Individual donor aliquots or pooled; 1 mL to bulk
Storage	−80 °C; shipped on dry ice

Bioanalytical Method Validation — FDA & EMA Matrix Requirements

Both FDA (2018) and EMA (2011) bioanalytical guidance require matrix matching with the intended study matrix. For human PK studies, this means validated calibrators and QCs prepared in human serum or plasma — with at least six individual donor lots demonstrated for selectivity.

Need EDTA plasma in K2EDTA, K3EDTA or sodium EDTA, individual donor sets or hemolyzed and lipemic plasma for your PK method? See our page on human EDTA plasma for PK studies and bioanalysis.

Validation Requirement	What You Need	SeamlessBio Format
Selectivity (≥ 6 individual donor lots)	6 × individual serum or plasma lots, same matrix type	Individual donor aliquots, lot-specific CoA per vial
Matrix effect (IS-normalised)	≥ 6 individual lots, spiked at LQC and HQC	Individual lots, matched anticoagulant
Calibrator / QC preparation	Pooled matrix, protein-normal, documented	Pooled Human Serum AB or pooled citrate plasma
Haemolysed / lipaemic matrix	Surrogate samples for interference testing	Available on request

Frequently Asked Questions

Why Type AB male serum specifically?

Type AB serum contains no ABO antibodies, eliminating one source of lot-to-lot interference in immunoassays. Male donors are preferred because female donors may carry HLA antibodies from prior pregnancies, which can interfere with certain assay formats. For most IVD calibration and cell culture applications, AB male pooled serum is the industry standard.

Can I request individual donor lots for selectivity testing?

Yes. SeamlessBio supplies individual donor aliquots with per-lot CoA and donor screening documentation — specifically to support the six-lot selectivity and matrix effect panels required under FDA and EMA bioanalytical guidance. Contact us with your volume and lot count requirements.

What is the minimum order quantity?

There is no minimum order. Method development quantities starting from 1 mL per lot are available. For larger validation panels or production batches, we supply up to bulk volumes — contact us for a quote.

How quickly can you deliver to Germany, Austria, and Switzerland?

Standard delivery: 24–48 hours to Germany and Austria; 2–3 days to Switzerland (export documentation included). Shipment on dry ice; cold-chain continuity documentation available on request.

Can Human Serum AB be used for cell culture — T cell expansion, CAR-T, MSC?

Yes. Human AB Serum is used as a supplement in serum-containing media for primary cell culture, T cell expansion, and MSC culture where a human matrix is required to avoid xenogeneic components. It is not a GMP-grade ATMP starting material by default — contact us if GMP documentation is required for your application.

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Order Human Serum or Plasma — or Request a Custom Lot

Tell us your matrix type, volume, donor lot count, and application. We respond within 24 hours with a quote and available lot documentation.
Email: info@seamlessbio.de | +49 851 37932226

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