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Catalent Expands Biologics Analytical Capabilities at its Kansas City, Missouri Site

Catalent is investing $12 million to increase its biologics CGMP analytical capabilities with the addition of two new analytical development laboratories to support the growing demands of assay development for both traditional biologics and advanced modalities, including antibody-drug conjugates, cell and gene therapies and mRNA vaccines.

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Harnessing mRNA as a Readout to Develop Robust Biopotency Assays

Transcriptional activity within a call can be used to evaluate cell response to a ligand or promoter activity. 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.

Watch this on-demand webinar to learn about the potency bioassay using RT-qPCR to assess relative transcription activity, the advantages and disadvantages of the assay compared to reporter gene assays and assays used for the analysis of cell and gene therapies.

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Exploring New and Improved Analytical Methods for Traditional and Unique Modalities

Biophysical characterization is critical to understand the make-up and behaviors of biologic therapies and vaccines, both early in development and throughout the manufacturing scale-up process. As biologics become more complex in structure, and as scientists improve their understanding of the effects of structure on stability, efficacy, safety, etc., there is a need to develop new and improved analytical methods to characterize biologic products.

Watch this on-demand webinar to learn about a method to evaluate extractables and leachables in order to measure residual-free toxins during antibody-drug conjugate (ADC) development and common techniques used to identify, characterize and quantitate sialic acids on biologics.

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