Video
mRNA Development and Manufacturing - CMC challenges and Solutions
Summary: Breaking New Ground: Turning mRNA into an Established Therapeutic Modality (Video 2 of 3 in the mRNA fireside chat series with Catalent’s experts).
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Video
mRNA: A New Option for Vaccines and Therapeutics
Summary: Breaking New Ground: Turning mRNA into an Established Therapeutic Modality (Video 1 of 3 in the mRNA fireside chat series with Catalent’s experts).
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Executive Summary
Scale-up Strategies for Late-stage Cell Therapies
Summary: In this executive summary, discover how Catalent’s Manufacturing by Design (MbD) strategy can help achieve efficiencies, drive cost savings, and develop and implement a robust, reproducible manufacturing plan for late-stage and commercial launch.
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Webinars
Early Phase Support for Plasmid DNA Supply Helps Secure Future Manufacturing for Advanced Therapies
Summary: Watch this webinar for an in-depth discussion of the challenges CGT innovators face and how experts resolve these barriers through adopting technologies and strategies that drive an optimized...
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Webinars
Streamlining Process Characterization Toward Successful Validation Campaigns
Summary: In this webinar, we explore the drivers for process characterization and late-phase development including improving process understanding, enhancing robustness, and assurance that it delivers...
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Article
Process Validation: A Critical Step in a Biopharmaceutical Product’s Lifecycle
Summary: Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches commercial launch...
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Executive Summary
Plasmid DNA Platform Supports Early Phase Advanced Therapies
Summary: Discover how a platform process for the manufacturing of plasmid DNA is helpful for all stages, from screening candidates in preclinical studies to large-scale production for late-stage and commercial needs.
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Video
iPSCs, a Universal Starting Material for Cell Therapies
Summary: iPSCs are a critical starting material and enable the availability of next-generation cell therapies for broad patient populations. Learn more about Catalent’s GMP iPSC capabilities including reprogramming, differentiation, and cell banking, and how they can create a path to make cell therapies more accessible.
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Executive Summary
Obstacles and Opportunities in Orphan Biologics-From Development to Production and Supply
Summary: In this article, experts detail how drug developers overcome obstacles that may complicate the launch of orphan drugs in order to meet their own needs and the needs of patients.
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Offering Fact Sheet
SMARTag® ADC Technology
Summary: Catalent’s SMARTag platform technology offers ADC and biologics innovators a toolkit to develop optimized ADCs and bioconjugates.
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