Webinar: Best Practices, Strategies & Utilization of Novel Biological Responses for Robust Cell-Based Potency Assays
Transcriptional activity within a cell can be used to evaluate cell response to a ligand or promoter activity within a transgene or plasmid within a cell. Catalent has developed a relative potency bioassay using real-time quantitative reverse transcription (RT-qPCR) in a duplex format to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay utilizes two fluorescent dyes with minimally overlapping emission spectra that allow real-time monitoring of the gene expression of both target and normalizer genes. Notably, the assay simplifies the process by eliminating the need for mRNA purification, enabling more efficient and accurate analysis. Normalizing the qPCR cycle thresholds (CT) of the target transcript to the reference transcript allows the response curve to be generated and compared to a reference standard. The generation of a four-parameter fit curve analysis from raw qPCR cycle threshold data allows for the comparison of relative potency and assessment of suitability based on curve parallelism. Catalent has successfully implemented this assay platform to develop a reliable, accurate, and specific bioassay. It stands out for its linear response and reproducibility, making it a valuable tool for evaluating the relative potency of various test substances. Join us to explore how these robust cell-based potency assays can enhance your research and provide critical data on drug product potency.
GMP Validated Next Generation Sequencing Services: Viral Safety Testing & Genetic Characterization
March 26th 2025This brochure will expand on our NGS testing services to biopharmaceutical and biotech companies, including viral contamination testing and genetic characterization of cell lines, bulk harvests, virus seeds, and raw materials used for production of biologics including cell and gene therapy products.
Develop Potency Assays Early for ATMP Success
March 26th 2025Early potency assay development and MOA understanding are critical for ATMP success. Delays can increase costs and risk failure, but recent advances highlight the need for timely, validated approaches to ensure regulatory and commercial success.
Engage with Industry Leaders on Viral Clearance & Viral Safety at 2025 Summit
March 26th 2025Join on June 3-4 in Cologne, Germany to gain insights from leading regulatory authorities, academics, and industry practitioners who define how biologics, vaccines, and advanced therapeutic medicinal products (ATMPs) are evaluated. Discover the latest technologies, learn best practices, and understand how to design an efficient manufacturing process.
