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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Webinars
Webinar: Scale-up Strategies for Late-stage Cell Therapies
Summary: In this webinar, we explore the considerations that need to be taken during development to ensure manufacturing processes and our facilities can support...
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Webinars
AAV Platform Process Accelerating Production from Gene to Clinic
Summary: In this on-demand webinar, hear our product development expert discuss Catalent’s UpTempo Virtuoso AAV platform process, a scalable, CGMP-ready platform process that can significantly reduce the time from gene to clinic.
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eBook
4 Secrets to Reaching First-in-Human Trials Faster: How to Connect with the Right Outsourcing Partner for More Speed and Less Complexity
Summary: In this ebook, read how matching up with the right partner can help you seize the opportunities and assemble the foundation for a successful first-in-humans study
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Video
Drug Substance Manufacturing
Summary: Catalent's Biologics site in Bloomington, Indiana provides a drug substance manufacturing area that includes production bioreactors ranging from 200 L single-use to 2,500 L stainless steel.
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Podcast
Podcast: Obstacles & Opportunities in Orphan Biologics- From Development to Production and Supply
Summary: In this podcast, experts discuss how to overcome obstacles that span from discovery to launch of orphan drugs as well as discuss the needs of patients and drug developers in orphan biologics development.
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