Providing advanced characterisation programs for nearly 30 years, we support developers and manufacturers of bio/pharmaceuticals and cell or gene therapy products with expert GLP / GCP / GMP laboratory services supporting CMC development. We provide method development and validation to meet your milestones and regulatory requirements, advanced (bio)analytical services, stability testing, viral vector characterisation, aggregation, delivery technologies analytical support, QC testing, and determination of process residuals.
At Intertek, we believe in a best practice approach to supporting the analytical development of gene therapies that involve orthogonal techniques that are ideally, sensitive, accurate, and linear over a broad range. Our facility has been designed to handle recombinant genomic materials for the purposes of research and compliant testing, including specialist facilities for handling Class I and Class II Biological Agents. Our expertise can help you confirm identity and ensure your gene therapy product's safety, quality, purity, potency, and strength.