Wednesday, November 20, 2019 Daily Archives

Ten important lessons the cell and gene therapy industry can take from the bioprocessing industry

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It’s time to tackle the challenges of sustainable and cost-effective commercial manufacturing regarding cell and gene therapy. Cell and gene therapies have many of the same manufacturing needs as biopharmaceuticals. As a result, industry experts expect single-use technologies used in biopharmaceutical clinical trials and commercial production to play a larger role in the future development and production of cell and gene therapy. Single-use systems are already incorporated in the development of cell and gene therapies today. However, many of those…

November 20, 2019

WuXi on board for Tychan’s yellow fever mAb

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Wuxi Biologics will manufacture supplies of Tychan’s developmental yellow fever biologic for clinical trials. The drug in question – known as TY014 – is a first-in-class monoclonal antibody. It targets the envelope (E) protein on the surface of the yellow fever virus and prevents replication by limiting fusion to host cells. Earlier this month Tychan announced it had successfully completed Phase IA/IB safety studies. The firm also said it received regulatory approval to test the drug in a field study…

November 20, 2019

eBook: Addressing Production Complexities — Strategies for Working with Difficult and Susceptible Proteins

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All proteins are complex — but some are more complex than others, particularly when it comes to recombinant protein expression and production in commercial quantities. What works in a research laboratory to make a milligram of pure protein for study won’t necessarily work on a manufacturing floor to make kilogram batches for drug-product formulation. An increasing number of technological options are available, however, from a simple switch in expression host or adding folding steps in downstream processing to special genetic…

November 20, 2019

Indie 400: Eli Lilly cites tax reform in latest biomanufacturing expansion

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Eli Lilly will expand biomanufacturing capacity at its site in Indianapolis. US tax reform stoked the $400 million (€362 million) investment, the firm says. The investment at the Lilly Technology Center campus in Indianapolis, Indiana will be used to support the production of Lilly’s diabetes medicines, adding capacity and technology upgrades to its active ingredient, syringe filling, device assembly and packaging operations. “These investments will enhance our existing facilities that make insulin, provide additional capacity for our growing portfolio of…

November 20, 2019

MilliporeSigma: Over 90% growth comes from mAbs, despite new modality momentum

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MilliporeSigma is seeing “terrific momentum†from the burgeoning cell and gene therapy space, but says double-digit growth continues to be driven by monoclonal antibodies (mAbs). The recent buzz in biopharma has been around the cell and gene therapy space, along with other modalities such as mRNA. It is no surprise that news outlets, such as this one, focus on ‘new’ modalities such as cell therapies, gene therapies, and mRNA. These are touted as the next-generation in treating and curing diseases,…

November 20, 2019

Avantor partners with NIBRT to take on biopharma bottlenecks

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Avantor has teamed up with Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) to develop solutions for “bottlenecks†that increase the cost and time it takes to make biopharmaceuticals. The collaboration – financial terms of which were not provided – will see Avantor install in-line dilution systems at NIBRT’s facility in Dublin, Ireland. The idea is to provide technicians with hands-on experience of the technology according to Killian O’Driscoll, NIBRT director of projects. “The in-line dilution technology will be…

November 20, 2019