Crossing the Finishing Line: The first Implementation of RTRT/PAT for a BioTech Drug Product at Roche

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While control strategies, including Process Analytical Technology (PAT) and Real-Time Release Testing (RTRT) elements, are common in oral solid dosage forms (with in-process testing and spectroscopic methods widely accepted by health authorities), their application in aseptic manufacturing remains rare. This webinar details a pioneering use case at Roche: the successful integration and regulatory filing of RTRT elements into the release control system of a sterile biotech drug product at a commercial launch site. Key components of this RTRT control strategy included: Implementing a dedicated RTRT sampling point. Utilizing Raman spectroscopy as a multi-attribute method. Leveraging the existing rapid microbiology toolbox. The presentation will also address regulatory feedback and lessons learned during this implementation

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Descripción

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