Aseptic Manufacturing for mRNA, ADCs, and Novel Biologics - Seguridad Mania.com - España y América Latina

In this presentation, the evolving landscape of aseptic manufacturing for advanced modalities including mRNA therapeutics, and Antibody-Drug Conjugates (ADCs) will be explored. The session will emphasize phase-appropriate process validation strategies tailored to the unique challenges of early-stage development. Drawing from recent regulatory guidance and practical experience, the talk will dissect the scientific and risk-based approaches to validation, including: Aseptic Process Simulation (APS) as a cornerstone of sterility assurance Bracketing and matrixing strategies for batch validation under constrained development timelines Validation expectations for ATMPs and investigational biologics, referencing EMA and PIC/S Annex 13 principles Attendees will gain insights into: How to balance regulatory expectations with development agility. The role of risk assessments in defining validation scope. Strategies to ensure robust sterility assurance while enabling innovation in formulation and delivery technologies. This session is designed for professionals involved in quality assurance , regulatory affairs, and technical operations, offering a pragmatic framework for navigating aseptic validation in the dynamic field of biopharmaceutical development.