Synthetic disease state plasma

Human serum and plasma screened negative for your analyte, for disease-state material at a defined concentration, made under your own conditions and to your own requirement. Where native samples are scarce, expensive or impossible to obtain at the level you need, synthetic DSP gives you a reproducible alternative.

Your spec
Target concentration: Human
Matrix background: Your terms
Conditions and process

The problem

When native material runs out

Every assay developer meets the same wall: the sample you need does not exist in sufficient volume, at the right titre, or at all.

Extreme titres

High and low ends of a range that natural donors rarely present.

Linearity panels

Evenly spaced points across a range, which native material never provides.

Rare conditions

Low-prevalence disease where donor recruitment is impractical.

Volume at titre

Litres of material at a value a single donor cannot supply.

An honest caveat. Synthetic DSP is not a clinical sample and should not replace one in final validation. It is for development, linearity, spiking studies and control manufacture. We will tell you when native material is the right answer, because using synthetic DSP where a real sample is needed helps nobody.

Approach

How synthetic DSP is made

Made under your own conditions and to your own requirement.

Define the target
Analyte, concentration or titre, matrix, volume and the assay it must perform on.
Select the base matrix
Human serum or plasma screened negative for the analyte, so the background is authentic.
Spike and formulate
Native antigen, recombinant protein or purified antibody, added to the defined level under your own conditions.
Confirm on platform
Measured on the relevant platform to confirm it reads where it should, and adjusted until it does.
Stability and release
Held and re-tested to your own requirements before release.

Coverage

Example products

A few of our established synthetic DSP lines. Search the full range in the product finder.

Search the full range

Formats

What can be made

Single-point controlsDefined value

Linearity panelsMulti-point

Seroconversion panelsGraded series

MatrixHuman serum or plasma

VolumesVials to bulk

Repeat manufactureTo the same specification

Our Synthetic DSP range holds 20 established lines. For anything beyond that, tell us the analyte and matrix and we will confirm what we can supply. For native material, see bulk and custom plasma or the product finder.

Common questions

Before you enquire

Will synthetic DSP behave like a clinical sample on our assay?

Usually, because the background is genuine human matrix rather than buffer. But behaviour depends on your assay format, which is why it should be confirmed on your own platform before release. We supply an evaluation sample first.

Can a lot from two years ago be reproduced?

If it was built to a recorded specification, yes. That reproducibility is the main reason customers move to synthetic DSP for control manufacture.

Can synthetic DSP match my existing control?

Often, yes. Target your current control's assigned values and run both side by side on your platform before you switch.

Is synthetic DSP acceptable for regulatory submission?

That depends on your notified body and the claim being made. Synthetic DSP is widely used in development and control manufacture; final clinical validation normally requires native samples. We can supply both.

Describe the material you need

Analyte, target concentration, matrix and volume. We will tell you whether synthetic DSP or native material serves you better.

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