Wednesday, February 13, 2019 Daily Archives

Using Slope Spectroscopy Methods: Risk Assessment and Cost Savings

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The biopharmaceutical industry’s need for rapid, accurate concentration measurements of protein-containing products is critical. The protein-concentration assay measures ultraviolet absorption at 280 nm (A280) and usually is performed both as an in-process test and for product-release testing. The SoloVPE system can analyze samples across a wide range of target concentrations without the need for labor-intensive and error-prone dilutions. Slope Spectroscopy methods provide companies with a universal platform for determining protein concentration for all in-process, clinical, and commercial methods. During in-process UV…

February 13, 2019

Big Pharma and CAR-T: Testing the water or in at the deep end?

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Following Novartis and Gilead’s success, others are “scrambling to build up their T-Cell capabilities,†say venture capitalists. We look at where Big Pharma stands in this blossoming sector. Big Pharma firms will be looking at strategies to enter the chimeric antigen receptor (CAR) T-cell space, if they have not already, spurred on by the approvals in 2017 of Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) . This was the view of commentators and analysts at Phacilitate in Miami, Florida last month. Anna…

February 13, 2019

Meissner expanding footprint with Irish gov support

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Filtration firm Meissner will establish a facility in County Mayo, Ireland for the manufacture of single-use systems, creating 150 jobs. Meissner Filtration Products has taken advantage of a 34,000 square-foot facility Advanced Technology Building, constructed by Ireland’s investment agency IDA, and plans to expand it by a further 100,000 square-feet. The firm plans to construct a cleanroom within the existing facility to be used for the manufacture of single-use systems (SUS) to support biopharmaceutical clients. Adjacent land at the site…

February 13, 2019

Dual sourcing drives global network as WuXi inks Amicus deal

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WuXi Biologics will harness its growing global network to supply the commercial drug substance and product for Amicus Therapeutics’ Pompe biologic ATB200. Amicus Therapeutics is developing a therapy consisting of recombinant human acid alpha-glucosidase (rhGAA) enzyme with an optimized carbohydrate structure, administered with a small molecule pharmacological chaperone. The product, ATB200, will be made by contract development and manufacturing organization (CDMO) WuXi Biologics. The firm, which has been working with Amicus to scale-up the product over the past few years,…

February 13, 2019