Executive Summary
A Guide to Optimizing Analytical Strategies Throughout the Biologics Development Life Cycle
Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.
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Executive Summary
Quality by Design (QbD) for Biologics from a CDMO Perspective
Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.
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Case Study
Formulation Through Manufacturing Under One Roof: One Emerging Biopharma’s Experience
Summary: Learn how Catalent’s formulation development and integrated manufacturing services can help EBPs through the complexities of the drug development process.
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Offering Fact Sheet
Drug Product Development Services Infocard
Summary: Catalent Biologics provides comprehensive services to meet complex biologic development needs. Click to see our global locations and services...
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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
Overcoming Formulation Challenges for mRNA and High-Concentration Proteins
In this article, experts provide an overview of current challenges associated with high-concentration protein formulations and in formulating mRNA lipid nanoparticles (mRNA-LNP) and how to overcome them.
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Webinars
Annex 1: A Guide to EMA’s New Sterile Product Manufacturing Requirements
Watch this expert panel discussing the increased emphasis on risk management and contamination control strategies across the industry.
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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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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 – Overcoming Formulation Challenges for mRNA and High-Concentration Proteins
In this webinar, experts will discuss how to improve the formulation development of high-concentration mAbs for subcutaneous delivery to reduce viscosity, and potentially reduce costs and timelines, and how to overcome current challenges met in formulating mRNA lipid nanoparticles (mRNA-LNP).
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