Leveraging Novel Analytical Approaches For Advanced Therapies
The characterization and analysis of advanced therapies, such as cell and gene therapies (CGTs) can be difficult, as these products are designed to function using complex mechanisms of action (MOA)s. There are a wide range of challenges associated with accurately assessing the potency and impurity profiles of these complex biologicals. As many CGT programs qualify for accelerated review pathways, novel approaches for analysis and characterization can help generate data that allows for real-time decision making and faster development timelines. Catalent has developed a relative potency bioassay using quantitative polymerase chain reaction (qPCR) to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay platform can be used to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency for CGTs, mRNA- and other nucleic acid-based therapies.
New Strategies for a Better Glycosylation Profile
January 22nd 2025Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.
