April 5th 2025
The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
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.
Quality Is in the Eye of the Inspection System
November 12th 2008Until recently, automated inspection of solid-dose pharmaceuticals was crude, expensive, slow, and difficult to change over. But technological advances have ushered in a new class of vision-inspection systems that is more effective and more commercially viable than older systems.