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Formulation & stability primer

Buffers, storage temperatures and freeze–thaw caveats at catalogue scale—longitudinal stability curves belong to contracted studies.

Storage & shipping

Cold-chain excursions may perturb potency readouts—reconstitute/aliquot promptly per IFU.

Lyophilisates should minimise headspace cycling; longitudinal stability belongs to contracted studies—defer to shipped storage statements and representative stability blurbs.

Matrix compatibility

Stock formulations might clash with downstream ELISA/BLI/SPR buffers—buffer-exchange before quant workflows.

Freeze–thaw & pre-use checks

Multiple freeze–thaw cycles can aggregate proteins or drift potency—aliquot for single use. Quarantine visible particles/turbidity and contact support.

Linking to long studies

Formal IND or registration stability needs a scoped CMC study via services and QA—this primer covers catalogue-scale handling cues only.