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Value-stable formulation
Excipient and matrix choices that protect labile analytes so assigned values hold through drying, storage, and reconstitution.
Calibrator and control lyophilization services for QC material producers across Canada — freeze-drying that keeps assigned values stable, holds vial-to-vial uniformity, and reconstitutes the same way every time. We take the material from cycle development to documented pilot vial batches ready for value assignment and transfer.
Calibrators and controls only work if their assigned values stay put. Lyophilization gives QC producers the ambient-stable, long-shelf-life format the market expects, but every step of the cycle is a chance to shift an analyte, break commutability, or introduce vial-to-vial variation.
We treat value stability and reconstitution accuracy as the acceptance criteria, not an afterthought. The goal is a cake that reconstitutes to the same value in every vial, in every lot — so your value-assignment work survives the freeze-dryer instead of being redone after it.
Excipient and matrix choices that protect labile analytes so assigned values hold through drying, storage, and reconstitution.
Fill and cycle control that keeps concentration consistent across the batch — critical for a material used to judge other assays.
A cake that dissolves fully to a defined volume, so the end user recovers the assigned value without technique-dependent error.
Each stage is signed off before the next begins, so you always know what's locked and what the next manufacturer will receive.
We review your material, target format, and requirements, then say plainly whether we're a fit.
Cryoprotectant screening and thermal characterization so the product holds through drying and storage.
A reproducible cycle built around your formulation, verified against your acceptance targets.
Documented pilot production in glass vials, with batch records structured for technology transfer.
A general freeze-drying run can produce a good-looking cake that still recovers the wrong number. We build the formulation and cycle around value stability and commutability from the first trial.
If your question isn't here, send it — we'll answer before a first call.
It can, if the formulation isn't built for it — which is exactly what we develop against. We screen excipients and cycle parameters to protect labile analytes so recovered values stay within your acceptance range.
Yes. Multi-analyte calibrators and controls are common work; the challenge is a single matrix and cycle that keep every analyte stable at once, which we address at the formulation stage.
Through controlled fill and a validated cycle. For a material that judges other assays, vial-to-vial uniformity is a primary acceptance criterion, not a nice-to-have.
That depends on the analytes and matrix. We characterise the formulation up front and structure the work so stability studies can support the shelf-life claim you need.
We develop with commutability in mind and document the process so it transfers to your production. Formal commutability studies sit with your validation, but the freeze-drying won't be what breaks it.
Share your analytes, target levels, and stability goals. We'll tell you plainly whether the values will hold in a freeze-dried format — and how we'd get there.
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