Video
An End-to-End Enabler of Biologic Innovation
Abstract: As the biopharma landscape grows more complex, Catalent works to ease the challenges of biologics development for its partners.
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Presentation
Leveraging Gene Copy Number to Optimize Expression for Rapid, High-Titer Production of Complex Products in CHO Cells with GPEx® Lightening
Summary: Biotherapeutics are becoming increasingly sophisticated, often requiring the coordinated expression of multiple genes, processing enzymes, and cofactors.
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Presentation
SMARTag® Technology: Modular Design Solutions for Best-in-Class ADCs
Summary: Catalent’s SMARTag® Technology offers a versatile and innovative platform for the development of optimized antibody-drug conjugates (ADCs).
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Webinars
Leveraging Platform Processes For Developing And Accelerating Novel Gene And Cancer Therapeutics
This year, the long-awaited FDA draft guidance for Platform Technology Designation Program was launched. This critical guidance allows drug developers to leverage Platform Technology data in approved drugs if similar “platforms” are used, accelerating the approval process and therapies to patients. In this webinar, George Buchman will discuss Catalent’s approach to platform processes as well as securing an integrated supply chain.
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Video
JPM Week 2024: Addressing the Latest Market Drivers and Trends for Biologics and Sterile Injectables
Summary: In a recent presentation during the 2024 JP Morgan Healthcare Conference, Catalent’s Group President of Biologics Dave McErlane addresses the latest market drivers for Biologics and Sterile Injectables.
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Executive Summary
Executive Summary - Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing
Learn how Catalent took to a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline.
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Webinars
Webinar - Development of Orphan Biologics: Challenges and Opportunities
In this webinar experts cover aspects of clinical trial design for orphan biologics products, key strategies for ensuring clinical trial supply throughout clinical development and the regulatory and legislative framework for delivery to patients.
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Article
Article: Streamlining Process Characterization Toward Successful Validation Campaigns
Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.
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Webinars
Webinar – SMARTag® Technology, from Bertozzi Lab to Best-in-Class ADCs
In this webinar, Chemistry Nobel Laureate, Carolyn Bertozzi, Ph.D., Professor, Stanford University, Penelope Drake, Ph.D., Head of R&D, Bioconjugates, Catalent Biologics, and Seema Kantak, Ph.D., Senior Vice President, Biotherapeutics, Exelixis, discuss the latest trends in ADC discovery and development.
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Webinars
Webinar – Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing
In this webinar, experts will discuss the evolution of protocols associated with induced pluripotent stem cell (iPSC) generation and differentiation.
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