Critical Reagent Manufacturing
Prolytix manufactures critical reagents under an ISO 9001‑certified quality system to support bioanalytical and GMP release testing, providing greater control and confidence in assay performance.
Prolytix designs de novo bioanalytical and GMP release assays around reagents manufactured in‑house, including recombinant proteins, antibodies, and assay‑specific reagents.
In‑house manufacturing supports long‑term lot consistency, rapid method development, and reliable assay performance. Comprehensive reagent characterisation is performed to confirm identity, purity, biological activity, and stability.
Brochures
Process development, analytical development, and GMP testing and release services
Explore the analytical and bioanalytical services Prolytix provides to support large molecule drug discovery and development, from product characterization through GMP release. Capabilities include analytical method development, critical quality attribute testing, process development, stability testing, and bioanalytical assays such as pharmacokinetics, anti-drug antibody, neutralizing antibody, potency, and thrombin generation assays. Prolytix also offers GMP-compliant release testing and lifecycle management of critical reagents.
Resource details:
Resource type: Product brochure
Page count: 2
Read time: 3 mins





