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DESCRIPTION: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:\nAseptic Process Simulation (APS) as a cornerstone of sterility assurance\nBracketing and matrixing strategies for batch validation under constrained development timelines\nValidation expectations for ATMPs and investigational biologics, referencing EMA and PIC/S\nAnnex 13 principles\nAttendees will gain insights into:\nHow to balance regulatory expectations with development agility.\nThe role of risk assessments in defining validation scope.\nStrategies to ensure robust sterility assurance while enabling innovation in formulation and delivery technologies.\nThis 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.\n
DTSTART:20260929T133000
DTEND:20260929T140000
DTSTAMP:20260405T183301Z
LOCATION:Online
PRIORITY:5
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SUMMARY;LANGUAGE=es-es:Tecnowebinars.com - :: Aseptic Manufacturing for mRNA, ADCs, and Novel Biologics
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UID:ad2e9839aede51400b38b715b08f604a Tecnowebinars.com
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