Friday, May 4, 2018 Daily Archives

Lonza Building Hybrid Biomanufacturing Plant at NH Site

Lonza plans to bolster its mid-scale biomanufacturing and cell therapy capabilities at its site in Portsmouth, New Hampshire on the back of growing demand. The expansion will include mid-scale mammalian capacity through the installation of several 6,000 L bioreactors which will eventually replace stainless steel 5,000 L systems operating at the site. ā€œThis will be a hybrid facility combining stainless steel for the main reactor with single use technologies for some of the upstream and downstream processing,ā€ Sylke Hassel, SVP…

Teva: Migraine Mab Delay After ā€˜Negative Surpriseā€™ of Celltrion Warning

Manufacturing issues are likely to delay the approval of fremanezumab but Teva remains confident its migraine drug will launch this year. Teva Pharmaceutical Industries’Ā monoclonal antibody (mAb) candidate fremanezumab is under regulatory review as a preventive treatment for chronic migraine. The US Food and Drug Administration (FDA) has assigned fremanezumab a Prescription Drug User Fee Act (PDUFA) action date mid-June, but the firm announced yesterday it expects a delay on the decision due to manufacturing issues. ā€œThere’s not much doubt about…