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CMC Strategy Forum - Raw Materials: Challenges and Opportunities
CMC Strategy Forum - Science & Risk Based Stability Practices in Biologicals Development
CMC Strategy Forum - Innovation in the Formulation and Delivery of Biotherapeutics
Innovation in the Formulation and Delivery of Biotherapeutics
Defining and Developing Comparability Strategies for Novel and Complex Biotherapeutic
Establishing and Leveraging Platforms to Support Product Development
Securing Patient Well-being: Best Practices for In-Use Stability and Compatibility Studies
CGTP Summit Oral
DateJune 26, 2023Comparability assessments for cell-based therapies are challenging due to complex manufacturing processes, inherent variability of cell starting materials, and evolving understanding of product quality attributes and analytical technologies…Session Chairs
DateJune 26, 2023Viral vector-based gene therapy products are the fastest growing segment of the gene therapy field, with adeno-associated virus (AAV)-based vectors dominating the landscape…
DateJune 26, 2023Comparability assessments are necessary for life cycle management of all biological products, including cell and gene therapies (CGT), and are conducted to ensure that manufacturing changes do not adversely impact product quality, safety, or efficacy…Session Chair
DateJune 10, 2024ADVANCING COMPARABILITY UNDERSTANDING OF CELL-BASED MEDICINAL PRODUCTSSession Chair
DateJune 10, 2024ALLOGENEIC CELL-BASED THERAPIES
DateJune 10, 2024AUTOLOGOUS CELL-BASED MEDICINAL PRODUCTSSession Chairs
DateJune 10, 2024Tal Salz, _Dark Horse Consulting_Session Chairs
DateJune 10, 2024Barbara Bonamassa_, Italian Medicines Agency _
DateJune 10, 2024Engaging Global Regulators in Discussion on Comparability for Cell-based Medicinal Products: Industry Challenges and a Path Towards Harmonized Solutions
