On this episode of Molecular Moments, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
BioAgilytix provides the specialized small and large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay requirements. Our veteran team possesses expertise with primary cells and transformed cell lines. Working with our customers, we are able to develop and validate custom cell-based assays in line with all relevant regulatory guidelines and recommendations.
Cell-based assays are assays that use live cells to offer a relevant representation of a real-life model, promoting focused biological progress development. This allows for the tracking of dynamic variables such as the number of cells or their behavior. Cell-based assays can be used to evaluate a variety of functional and biochemical effects, including cell proliferation, apoptosis and cell death, signal transduction, enzyme activity, reporter gene activity, antibody-dependent cell-mediated Cytotoxicity (ADCC) and complement dependent Cytotoxicity, among others. These techniques are used to support neutralizing antibody (NAb) assays, relative potency assays, mechanism of action studies and drug combination analysis, to name a few.
Because live cells are used, cell-based assays provide a functional read-out of compound activity, or produce results that are more biologically relevant or have physiological relevance.
BioAgilytix’s ongoing partnership with ATCC brings together the complementary expertise and resources sponsors need to manage cell lines and develop cell-based assays.
The complexity involved in live cell analysis demands an advanced level of bioanalytical skill and knowledge – not just for the assay itself, but for the regulatory parameters that assay must uphold. With our scientific staff averaging 15+ years of experience developing and performing cell-based assays, BioAgilytix is uniquely qualified in this capacity.
Our team has vast experience with primary cells and transfected reporter-gene cell systems, and can develop and validate cell-based assays under GxP In fact, our scientists were responsible for lead optimization and mechanism-of-action studies that led to the discovery of several key drugs that are on the market today, as well as a number of promising clinical candidates.
We offer custom cell culture including primary explants, cloning, and optimizing expression of a cell line or development of the optimum medium, including serum-free medium. Additionally, purification of your protein can be performed from either cell extracts or the conditioned media.
BioAgilytix offers a diverse range of innovative platforms for cell-based assay work as part of our premier laboratory facility. We are able to provide multiplexing of our readouts and apply automation for increased assay throughput and reproducibility. Our scientists will help you choose the method to optimally support your distinct cell-based assay parameters, leveraging the range of platforms listed below.
BioAgilytix’s David Rusnak contributes to this article by Genetic Engineering & Biotechnology News (GEN) discussing how cell-based assays have become a mainstay of drug development.
BioAgilytix provides robust cell-based assay services to support drug development through all phases of a product’s lifecycle, from pre-clinical and clinical phases to lot release testing and post-marketing surveillance.
Whether performing ADCC and CDC assays, reporter gene assays, cutpoint and outlier statistical analysis, or drug combination analysis, we can tailor our cell-based assay services to meet your specific level of regulatory requirement. This can include measuring of neutralizing antibodies (NAbs), cell culture, and bioassays including cell lines, PBMCs, and BMMCs.
We are a specialized GLP / GMP compliant bioanalytical lab offering a unique combination of veteran expertise, premier lab facilities, and deep regulatory know-how, which we fully leverage in helping our customers compress their timeline from discovery to market.
Let BioAgilytix help you navigate the path to biologic innovation with expert cell-based assay services.