Process Development of an Efficient Large-Scale Manufacturing Process of a PEG-ylated Peptide: Pegcetacoplan
by Arne Berthelmann, Director R&D, Bachem
Bachem, in collaboration with Apellis, presents state-of-the-art developments for the manufacture of pegcetacoplan (the active ingredient in EMPAVELI®) and illustrates how a commercial manufacturing process is achieved with the required efficiency gains and control of cost of goods. The application of automation in down-stream purification to eliminate bottleneck unit operations and the replacement of lyophilization with precipitation as final isolation step are being discussed including stability, physical and chemical properties of lyophilized versus precipitated pegcetacoplan.
Main Conference, Day 2 – Friday, November 18, 4:00pm