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| Filter Validation Made Easy | Mitigating risk is central to safe biomanufacturing. When it comes to aseptic processing, understanding the risk factors for sterile filtration and single-use systems is increasingly important. However, validation can be a time-consuming process — and getting it right is essential to your path to regulatory approval. Learn more about using our services to implement a risk-based approach to validation studies for sterilizing filtration and single-use systems in our white paper. |
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By Padmini Ayapilla, Freyr Solutions | This article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the emergency use authorization, post-approval surveillance and monitoring, and more. |
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Success at multimodal, multi-indication, deep-pipelined Incyte—where commercial operations are as familiar as pre-discovery activity is—begins at the earliest opportunity to achieve research and discovery efficiencies. |
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| Cryopreservation In Stem Cell Therapy | Article | Corning Life Sciences | The cryopreservation process maintains the structural integrity of living cells, but what other information is crucial for manufacturers when considering cryopreservation and its impact on cell-based therapies? |
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| Build Your Genome Engineering Toolbox For Success | White Paper | By Claes Gustafsson, Ph.D., ATUM | Fast, efficient, and precise options for genome engineering are rapidly infiltrating the marketplace — the key to success is identifying the mechanism and tool(s) best suited for your goals. |
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| Overcome Common Media Scalability Challenges | Article | Thermo Fisher Scientific | Streamline the transition to commercial manufacturing through four key development considerations: format conversion, manufacturability, supply insurance, and batch-to-batch consistency. |
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| Gifts To Solve Ex Vivo Gene Delivery Challenges | Article | By Jon Carson, Terri Willstaedt, and Mary Doolin, RoosterBio | Explore the tricky challenge of gene transfer into primary cells, along with the impact of genetic engineering on the next wave of cell and exosomes advanced therapies and other developments. |
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| In a period marked by resource constraints, focusing R&D on the most likely molecules to succeed is paramount. But how do you do it? Don’t miss our first Bioprocess Online Live of 2024 as we explore the most efficient approaches to scalable discovery, molecular screening and assays, definition of CQAs, establishing a proof of concept, and assessing developability. Registration is free for this January 23rd event. |
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