Wednesday, March 17, 2021 Daily Archives

Takeda loans J&J CDMO space to support COVID vaccine roll out

IDT Biologika will use capacity reserved for Takeda’s dengue vaccine candidate to provide fill-finish for Johnson & Johnson’s COVID-19 single-shot jab. Contract development manufacturing organization (CDMO) IDT Biologika had been contracted to use its Dessau site in Germany to manufacture Takeda’s dengue vaccine candidate, TAK-003. However, the facility will now be dedicated to filling and packaging J&J’s vaccine, which received US Food and Drug Administration (FDA) approval in February this year. J&J’s vaccine will be manufactured at the Dessau site…

Understanding Viral Clearance During Anion Exchange Chromatography by Using a Novel Design of Experiment Approach

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This webcast features: Moira Lynch, Innovation Leader, Purification and Pharma Analytics, Thermo Fisher Scientific, and Zhijun (George) Tan, Associate Scientific Director, Bristol Myers Squibb Demonstrating viral clearance of a downstream process is a requirement for drug candidates such as monoclonal antibodies (mAbs) that proceed to phased clinical trials. Due to the specialized nature of viral clearance studies, these studies are often outsourced to dedicated companies, making this a costly process. This expense pushes these studies off until absolutely necessary and…

Lonza dedicates suite to make Altimmune’s nasal COVID-19 vaccine

Lonza will commission a dedicated suite at its Houston, US facility for supply of Altimmune’s AdCOVID, a nasal COVID-19 vaccine that entered Phase I trials last month. Last November, Altimmune entered an agreement which meant that Lonza would provide commercial production capacity for AdCOVID from its Houston, US, site. Now, Altimmune has expanded its manufacturing partnership with lonza by adding capacity and stability through its own dedicated suite. “Our recently inaugurated Houston facility is our center of excellence for process…

Ins & Outs: Ex-Lonza CEO joins Recipharm, plus changes at Moderna

Marc Funk has joined CDMO Recipharm as its new CEO, while Moderna pinches Novartis’s chief legal officer. Meanwhile, there are high level changes at Univercells Technologies. It’s lovely to have you here for another BioProcess Insider’s, Ins & Outs. This week, Marc Funk announced on LinkedIn  that he has joined Recipharm as CEO. Funk has replaced contract development manufacturing organization (CDMO) Recipharm’s former CEO, Thomas Eldered who had held this position since 2008. “It is a great pleasure to be…

Pfizer exits Chinese biosimilars space, selling plant to WuXi

As part of a “difficult decision” to halt its biosimilars programs in China, Pfizer is offloading its single-use biologics manufacturing plant in Hangzhou to WuXi Biologics. Pfizer is one of the world’s largest biosimilar manufacturers, with seven commercialized products in the US alone (Inflectra, Retacrit, Nivestym, Nyvepria, Zirabev, Trazimera, Ruxience). In 2016, Pfizer took aim at the Chinese market by investing $350 million in the Hangzhou Economic Development Area (HEDA) to set up a biosimilars manufacturing facility. Five years on…