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.
CGMP-Compliant iPSC Manufacturing and Development of Differentiated Cells for Advanced Therapies: Strategies and Challenges
In this webinar, experts discuss the current state-of-the-art for iPSC generation and differentiation. The presentation will also highlight the development of advanced CGMP-compatible protocols for converting these cells into several cell types of therapeutic relevance, including retinal pigment epithelium (RPE), mesenchymal stem cells (MSCs), cardiomyocytes (CMs), and immune natural killer (NK) cells.
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.
Accelerating Your Gene Therapy to Patients: Not All Platforms Are Created Equal
In this fireside chat, George Buchman, Ph.D., Vice President, Pre-Clinical and Process Development, Catalent Cell & Gene Therapy and Thomas VanCott, Ph.D., Chief Scientific Officer, Combined Therapeutics, explore how a complete platform approach to fast-track AAVs can enhance quality and efficiency.
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.