Best Practices, Strategies & Utilization of Novel Biological Responses for Robust Cell-Based Potency Assays

RT-qPCR is a rapid and sensitive bioassay designed to detect subtle gene expression changes, crucial for evaluating the potency of therapeutic biological products. Join Catalent’s webinar to learn how this technique enhances drug potency analysis, streamlining the evaluation of cell response to ligands and transgenic vectors.

Register Free: https://www.pharmtech.com/pt_w/novel-biological-responses

Event Overview:

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 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.

Key Learning Objectives:

• Discover Catalent’s novel potency bioassay using RT-qPCR to assess relative transcription activity
• Understand the advantages and potential limitations of transcriptional assays compared to reporter gene assays
• Explore how transcriptional assays compare to ddPCR and flow cytometry for cell and gene therapy analysis

Who Should Attend:

• Procurement
• Head of Mfg
• Head of Ops
• Head of R&D
• Head of Sourcing
• Alliance Manager/External AM
• Head of CMC
• Head of Analytical Development
• Head of Product Development
• Head of Formulation Development
• Consultants

Speaker:

Pedro Morales
Director, Biologics Analytical Services
Catalent

Pedro Morales joined Catalent in 2007 and is currently a director of Biologics Analytical Services. He oversees cell-based and non-cell based functional assays, including analytical process impurities, at Catalent’s Kansas City location. He has over 30 years of experience supporting biologics analytical sciences, with previous roles at Aptuit and the University of Kansas. Pedro received his Masters in Biochemistry and Molecular Biologics at the University of Austral Chile.

Register Free: https://www.pharmtech.com/pt_w/novel-biological-responses