ATMP Analytical Development Services & CMC Support

Our GLP / GCP / GMP laboratories have supported developers and manufacturers for over 20 years through the provision of advanced characterisation programs. We have worked on multiple studies involving cell or gene therapies, mRNA and plasmid DNA-based products. With specialist laboratory facilities, we can handle Class I and Class II Biological Agents. The facility has been designed to handle recombinant genomic materials for the purposes of research and compliant testing. Cell and virus characterisation Viral vector identity Virology assays Host cell and residual plasmid DNA Cell-based assays/potency testing General compendial testing GMP analysis GCP/GLP bioanalysis ICH stability storage and testing Method development and validation QC release testing Advanced delivery technology analytical support Liposome drug product characterisation https://www.intertek.com/pharmaceutical/biopharmaceuticals/advanced-therapy-medicinal-product-analytical-services/