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| Given the complexity of mRNA, rigorous characterization and testing are required to ensure safe and effective mRNA drug products. This white paper provides a detailed description of assays for sequence identification and LNP composition, two critical quality attributes of mRNA-LNP products. Learn more. |
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Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing. |
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By Francesco Destro and John Joseph, MIT | Current processes in recombinant adeno-associated virus-based gene therapy production are generally not readily scalable. A group of scientists and engineers at MIT collaborated with the team at UMass Chan Medical School to develop a mechanistic model for the intracellular phenomena occurring during baculovirus infection and rAAV virion production in insect cells. A free and user-friendly implementation of the model is available online, and anyone can use it to test a wide range of conditions and hypotheses. |
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| Protein Capture Devices With Protein A: Improve Purification Times | Application Note | By Lauren Parker, Jeffrey Cassel, Mike McManaway, and William C. Barrett, Ph.D., W.L. Gore & Associates | This protein capture device demonstration showcases a cycling protocol that uses fast loading and non-loading residence times as well as a rapid CIP out to 100 cycles. |
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| Addressing Cell Line Development Bottlenecks | Application Note | Advanced Instruments, Inc. | Explore study results demonstrating the ability of a specialized reagent to substantially improve the cell line development workflow cloning phase for the manufacture of protein biologics and viral vectors. |
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| Gene And Cell Therapy Analytical And Development Methods | White Paper | Pfizer CentreOne | Explore the importance of implementing development approaches early in the product life cycle and how analytical method choice impacts the production of safe and efficacious gene and cell therapies. |
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| LNP Formulation For mRNA Delivery | Article | Cytiva | Microfluidic mixing is one of the most effective means to formulate lipid nanoparticles (LNPs). Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more. |
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| Your Capital Equipment Project Is Cancelled: Now What? | Article | By Matt Hicks, Federal Equipment Company | Late-stage clinical trial failures usually result in exposure regarding capital equipment purchased to manufacture that product at a commercial scale. But what to do with this brand new, surplus equipment? |
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| The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision makers in the industry to advance cutting-edge research into cures. This year’s program will feature expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 100+ dedicated presentations by the leading publicly traded and privately held companies in the space. Register today. |
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LIFE SCIENCE LEADER MAGAZINE |
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Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business. |
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