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This presentation will cover WuXi Biologics’ new biopharmaceutical contract manufacturing facility in Dundalk, Ireland, which has set industry benchmarks in time to market, scale, and flexibility. A unique approach to the process scope of supply was a key factor in this achievement. WuXi Biologics chose the largest available single use bioreactors (4,000L), a hybrid single-use/stainless steel process design, and an integrated approach for process design, manufacturing, installation, and commissioning. The result is a highly flexible, large-scale process that was turned over only 28 months after start of design, with much of the project occurring during the COVID-19 crisis. In this talk, we provide details of the process scope as well as the project execution approach.
With demand outstripping supply and the increased focus on access to medicine, the need to maximize production yield and throughput in biopharma remains a high priority…
How does standardization of aseptic filling accelerate drug development? Traditionally aseptic filling processes were developed as a custom solution late in the drug development process, often dedicated to a single drug candidate…
Key challenges in pDNA manufacturing exist around purification unit operations due to its large size, high viscosity, shear sensitivity, and similarities between pDNA and impurities…
We developed a GMP modular continuous processing system that lowers the hurdles of adopting new technologies. This technology was designed to (1) meet drug product demand, (2) provide modular, mobile manufacturing, and (3) reduce environmental impact. Demand for Covid mAbs increased 20X in 2…