John Amara, Ph.D. and Michael Dullen, Merck

Recent advancements in the productivity of upstream cell culture processes for the manufacture of therapeutic proteins, including monoclonal antibodies (mAbs), have resulted in greatly elevated cell densities and higher levels of process-related impurities. Current depth filters may demonstrate an insufficient filtration capacity for these applications and often comprise naturally-derived materials which require increased flushing to remove undesired organic and inorganic extractable components.