ACF Bioservices (an Absorption Systems’ Company) has the expertise and relevant experience needed to provide analytical support for gene and cell therapy products through every stage of development. Potency assays are on the critical path and ACF offers de novo development, optimization, qualification, validation and GMP compliant final product and product release testing services for both allogenic and autologous therapies.
We have the capability to develop both in vitro and in vivo models to better predict human outcomes and correlations between animal studies and in vitro cell-based assays. Our fully compliant facilities and studies and have been inspected by the FDA, USDA and AAALAC. ACF has over 20 years of business operating expertise developing proprietary assays, combining our skills in cell and molecular biology, assay development and validation, bioanalytical and immunochemical quantitation, statistical analysis and regulatory affairs in a single-source collaboration.