Friday, November 16, 2018 Daily Archives

Filtration and single-use drive robust quarter for MilliporeSigma

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Merck KGaA reported a 16% year-on-year growth for its MilliporeSigma Process Solutions business and expects continued strong demand from biomanufacturers to drive high single-digits in the long-term. “Thank you sir, can we have another (Q like this one),†Evercore ISI analyst Luke Sergott wrote in an note describing German Merck’s third quarter 2018. While group sales grew 6.6% year-on-year to €3.7 billion ($4.2 billion), it was the life sciences MilliporeSigma division which really shone. The Process Solutions business unit grew…

November 16, 2018

Rentschler $34m Austrian plant to feed freeze-drying capacity demand

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Rentschler Fill Solutions has inaugurated a €30 million ($34 million) fill & finish facility in Austria. The site will produce Mepsevii (vestronidase alfa) drug product for Ultragenyx Pharmaceutical. Construction of the facility began in July 2016, and the plant received GMP approval in August this year. But today (Friday) the contract development and manufacturing organization (CDMO) officially inaugurated the facility in Rankweil, Austria. The clinical and commercial plant forms part of Rentschler Biotechnologie’s strategic alliance with Leukocare, which aims to…

November 16, 2018

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

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Marketing unapproved stem cell therapies and cGMP deviations have landed California’s StemGenex Biologic Laboratories with a US Food and Drug Administration (FDA) warning letter. The letter cites issues in good manufacturing practice (GMP) and the unlawful marketing of an unapproved stromal vascular fraction (SVF) stem cell therapy, processed from autologous adipose tissue. It was sent on October 31, following an FDA inspection at StemGenex Biologic Laboratories’ (SGBL) facility in San Diego, California in January this year. According to the Agency,…

November 16, 2018