News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
ChromaTan will incorporate Purolite’s Protein A beads into its continuous platform in a move the firms say will up productivity by 15 times over conventional batch chromatography.
Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.
The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.
Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohn’s disease stem cell therapy licensed from TiGenix.