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Creating well-defined parameters for virus filtration validation is crucial to avoid complications and delays, and selecting the appropriate viral filtration studies is important. Explore guidance regarding the effective validation of a virus filtration process in the lab, including the fundamentals of viral filtration and an examination of relevant regulatory guidelines.
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Virus filtration is critical for ensuring viral safety in biotherapeutic manufacturing. Leveraging new industry insights, several contemporary challenges have been successfully addressed. This study offers valuable insights to guide informed decisions in virus filtration, aligning with the PDA TR-41 (2022) and the ICH-Q5A updated guidelines.
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While filters that are capable of removing 99.98% of particles of a particular size are considered high-performing, this may only apply to non-deformable particles and with the requirement that the filtration matrix itself is unaffected by the process. Learn why sterilizing-grade filters are necessary to effectively remove bacteria and viruses from critical filtration processes.
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Virus filtration is a robust mechanism to ensure the virus safety of biotherapeutic manufacturing processes, and must be validated under simulated worst-case processing conditions to meet regulatory expectations. Here, Dr. Nigel Jackson, Principal Engineer in R&D, outlines regulatory changes and updates pertaining to virus filtration.
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The landscape of drug formulations is evolving, with a growing preference for subcutaneous administration over intravenous infusion. Explore an approach to developing a new sterilizing-grade filter for high-concentration biologics that enables extensive filterability trials to be conducted without needing a large quantity of the costly product.
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This study presents scalability data for depth filter capsules across process development, pilot, and manufacturing scales. Explore findings aiming to assist process development scientists and engineers in understanding the structure of these devices, identifying key parameters for development, and setting appropriate safety factors during scale-up.
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Here, we showcase the scalability of disposable depth filters, demonstrating their effectiveness from lab-scale to manufacturing-scale capsules. Filter performance remains consistently high across various scales, as evidenced by metrics including filtration throughput, turbidity reduction, impurity removal, mAb yields, and particle counts.
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