June 6th 2025
ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.
Silicone Microdroplets in Protein Formulations—Detection and Enumeration
January 2nd 2009The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.
Merck Forms Follow-On Biologics Business; Emphasizes Emerging Markets
December 18th 2008At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.