Podcast
Platform Processes for Streamlined Regulatory Filing and Decreased Time to Market for Gene Therapies
Summary: In this podcast, we will discuss how Catalent is working to simplify the supply chain, develop processes scalable for late-stage and commercial needs, and accelerate timelines for production of clinical materials.
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Webinars
Accelerating Advances in Cell and Gene Therapy Production
Summary: During this webinar, we reviewed progress in several areas of advanced development and their impact on readiness for large scale manufacturing.
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Video
Plasmid DNA: Integrated Solutions for Cell and Gene Therapies
Summary: Plasmid DNA is a critical raw material for cell and gene therapies. Discover the importance of having an integrated partner like Catalent Cell & Gene, and how we can keep your development and manufacturing on track and on schedule.
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Offering Fact Sheet
Plasmid DNA Manufacturing
Summary: The Catalent team has broad expertise in developing customized plasmid DNA manufacturing solutions, from plasmid engineering to large-scale GMP plasmid production.
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Article
Overcoming the Raw Material Hurdle: Plasmids for Viral Vector-Based Gene Therapies
Summary: Learn how Catalent Cell & Gene Therapy recognizes the challenges faced when obtaining raw materials, and how our investments in pDNA manufacturing secure our integrated supply chain.
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Executive Summary
Readiness through Planning and Alignment: Guiding Gene Therapies from Clinic to Market
Summary: Learn how integrated service providers can streamline manufacturing, development and commercialization for optimal regulatory and process outcomes for gene therapy programs.
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Executive Summary
Are Real-Time Gene Therapy Test Results Possible?
Summary: Along with the complexities of vaccine and viral-based gene therapy process development comes the need for analytical techniques that can help assess quality parameters, in real-time.
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Executive Summary
Formulation Strategies for AAV-Based Gene Therapies
Summary: In this executive summary, our expert discusses how Catalent Cell & Gene Therapy continues to learn about formulating gene therapies by adapting methods used for other biologics.
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Webinars
Formulation and Characterization Strategies for Gene Therapies
Summary: In this on-demand webinar, our expert discusses how Catalent Cell and Gene Therapy is working towards an approach for gathering product knowledge and establishing formulation selection criteria using traditional/routine techniques as well as evaluating novel methodologies for gene therapy products.
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Video
Measuring Quality Attributes for Gene Therapies: Empty vs Full Viral Vector Capsids
Summary: Catalent offers tools to measure the ratio and help assess the safety and efficacy of viral vector-based therapies.
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