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Through case studies and practical insights spanning complex drug substance and drug products like ADCs, learn more about navigating complexities with integrated regulatory services and strategic guidance. Find the significance of regulatory acumen, interdisciplinary teamwork, and flexibility for achieving success.
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Walk through some of the most important initial steps to consider and implement during the process design phase (Stage 1 of Process Validation), which is a pre-requisite to a successful PPQ campaign (Stage 2) and readiness for commercial manufacturing. Learn strategies to ensure successful process characterization as part of process design.
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Are you facing challenges in transferring your biological product from development to manufacturing? Get an in-depth exploration of the critical aspects of technology transfer for both drug substance and drug product. Review best practices to ensure seamless processes, navigate regulatory hurdles, and maintain consistent product quality.
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Complex next-generation biological molecules, with their intricate structures and variations, present unique challenges. Through case studies, explore strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.
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There is a need for flexibility in drug development and manufacturing capacity. Jeffrey O’Connor, Executive Director of Commercial Development, answers questions about the challenges in the changing biologics manufacturing market and the solutions available to help customers successfully develop and manufacture lifesaving products.
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