Monday, April 30, 2018 Daily Archives

eBook: Production Cell-Line Development and Control of Product Consistency During Cultivation — Myths, Risks, and Best Practices

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Health authorities are requesting substantial details from sponsors regarding practices used to generate production cell lines for recombinant DNA–(rDNA) derived biopharmaceuticals. Authorities also are asking for information about the clonality of master cell banks (MCBs) and control strategies to minimize genetic heterogeneity. Such requests are prompted by recent reports indicating “nonclonality†for certain production cell lines. To address these and related issues, the CASSS CMC Strategy Forum on “Production Cell Line Development and Control of Product Consistency During Cell Cultivation:…

April 30, 2018

Beyond Adcetris: Seattle Genetics Aiming for Big Biopharma Status

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Profitability will be placed on the backfoot as Seattle Genetics looks to grow into a “powerful big expansive company,†the firm says. For the first quarter 2018, total revenues grew to US$141 million (€116 million) compared to $109 million in the same period last year. This was attributed to a 36% increase in sales of Seattle Genetics’ antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin), which pulled in $95 million of sales. Total costs for the quarter, meanwhile, jumped by almost 30%…

April 30, 2018