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.
Why use a CRO?
For CGT products, the drug development paradigm has shifted, and it is becoming increasingly realistic to proceed from Phase 2 trials to a pivotal trial. Therefore, commercialization strategies must be considered much earlier in the development cycle.
Custom developed potency release assays can be extremely complex and require extensive development time. Therapeutic products cannot be released until these assays are fully validated and performed in a cGMP compliant facility.
A nonclinical CRO provides experience and knowledge with a breadth of models (in vivo, ex vivo, and in vitro), analytical techniques, redundancy in equipment, trained analysts, compliant facilities and quality systems.
The CRO performing the potency assay stays with the product throughout development and commercialization. They can help bridge the gap from understanding a CGT product’s unique challenges to meeting regulatory requirements for a potency release assay.
Decision makers should seek to maximize their investments by choosing outsourcing partners with the expertise to help facilitate regulatory approval.