Method Development
Prolytix provides custom bioanalytical method development and validation services to support large‑molecule drug products, delivering relevant and reliable data for preclinical, clinical, and CMC studies.
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Analytical method development evaluates whether an assay is effectively constructed to determine a drug’s identity, purity, physical characteristics, potency, and safety. Prolytix develops bioanalytical methods using a rigorous, science‑based approach.
Analytical method validation confirms that methods produce robust and reproducible results that meet regulatory expectations. Prolytix offers method development and validation services for pharmacokinetics, immunogenicity, biomarker assays, and protein characterisation.
These services are supported by more than 35 years of experience with large‑molecule drugs and protein analysis.
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
