How tailor-made processed human serum matrices are specified, developed and scaled — from analyte-specific depletion to bulk manufacturing.
Standard catalogue materials cover many applications, but assay development regularly runs into a requirement that no off-the-shelf matrix satisfies: an analyte that must be depleted below the limit of detection, a pH window a method depends on, or a target value that has to sit precisely between two decision points.
Specifying a custom matrix
A custom development usually starts with three questions:
- Which analytes must be present, and at what target values?
- Which analytes must be depleted, and to what level?
- What are the stability, volume and packaging requirements over the product life cycle?
Processing options
Depending on the answers, we combine defibrination, delipidation, charcoal stripping, analyte-specific depletion, pH adjustment, stabilisation and sterile 0.22 µm filtration into a defined process for that material.
From pilot to bulk
Development runs at pilot scale for feasibility and method verification, then transfers into routine manufacturing without changing the process — which is what keeps the pilot data meaningful once volumes increase.
Cost efficiency through focus
Removing parameters a scheme or product does not need reduces cost without reducing quality. For EQA providers in particular, tailoring the parameter list to the scheme is often the single largest efficiency gain available.