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By identifying a CDMO partner that can establish a tech transfer approach based on a well-defined and comprehensive roadmap, calibrated to a company’s capital and resources, and allows for bespoke processes, cell therapy developers can reduce risk, control costs, and maximize their molecule’s chances of late-stage success.
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Early product characterization can serve to uncover crucial information about a therapeutic candidate, affording new insight into its critical quality attributes (CQAs). This applies to more than potency – deep characterization studies can also provide understanding to inform safety, purity, identity, and other core attributes.
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The complexities of today’s biopharmaceutical development paradigm have necessitated novel approaches for early-phase workflows that can accelerate timelines and reduce cost and risk. For both process and analytical development, this drive toward more automated, closed processing has led to unprecedented innovation.
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This webinar emphasizes the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation for collaboration. Furthermore, it explores how a quality agreement incorporating governance policies and conflict resolution measures can enhance the agility of the partnership.
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Gain insight into the characterization of cellular source material for the development and manufacture of cell and gene therapy-based products, including the challenges related to sourcing and variability of cellular materials and how characterization assays can mitigate the risks of progressing living cells.
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OUTSOURCED PHARMA CAPACITY UPDATE VIDEO FEATURE
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In addition to immediate capacity for Draw-to-Thaw™ services in New York, NY and Louisville, KY, Comprehensive Cell Solutions has openings for process and analytical development work in its Houston, TX facility.
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