Prolytix Products & Reviews

Pharmacokinetics (PK) is a crucial part of biopharmaceutical toxicology that evaluates the absorption, distribution, metabolism, and excretion (ADME) of biotherapeutics. Prolytix offers robust PK assays to support preclinical and clinical phases of biotherapeutic development.

GMP release testing is a critical quality control process that ensures manufactured therapeutics meet predetermined specifications before release. Prolytix provides GMP release testing for clinical and commercial drug substances and drug products.

GMP stability testing determines how a drug product performs under routine and stressed conditions. Prolytix performs GMP‑compliant stability testing and provides ICH‑compliant storage to support clinical and commercial drug products.

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.

Protein characterisation services provide detailed analysis of critical attributes of large‑molecule therapeutics, delivering high‑quality data to support development decision‑making and regulatory submissions

Process development services support the isolation, purification, and optimisation of large‑molecule drug manufacturing processes. Prolytix provides consultative process development to support efficient biologic development

Biomarker assays are laboratory methods that detect or analyse genes, proteins, or other molecules in biological samples and are fundamental tests in biotherapeutic drug monitoring, research, and development. Prolytix offers comprehensive biomarker assay development, validation, and testing services.

Immunogenicity assays are critical assessments that screen for potential anti‑drug antibodies (ADAs) and support product safety and efficacy. Prolytix supports partners with comprehensive immunogenicity method development, validation, and testing for preclinical and clinical phases of biotherapeutic 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.

Custom collection devices are designed to preserve sample integrity for biotherapeutic research and clinical studies. Prolytix designs and manufactures custom‑formulated collection devices tailored to specific research needs.