Great strides have been made in increasing the yield of biotherapeutic proteins mainly through process improvements with a focus on media and feed strategies. But aside from single-gene knockouts to allow for metabolic selection systems, the Chinese hamster ovary (CHO) host cell line remains largely unchanged from what was used 30 years ago. In a webinar on 21 March 2018, Jamie Freeman (product manager at Horizon Discovery) focused on this as a bioproduction application of clustered regularly interspaced short palindromic…
Tuesday, May 29, 2018 Daily Archives
Teva Migraine MAb Approval Reliant on Celltrion Plant Fix
FDA approval of Teva’s fremanezumab depends on a speedy resolution of a plant run by CMO Celltrion but this is looking increasingly likely, an analyst says. The US Food and Drug Administration (FDA) had set the Prescription Drug User Fee Act (PDUFA) action date for fremanezumab, a humanized monoclonal antibody targeting calcitonin gene–related peptide (CGRP) for mid-June. But Teva Pharmaceutical Industries envisioned a delay after its contract manufacturer Celltrion received an FDA warning letter in January. Celltrion’s site in Incheon,…