November 22nd 2024
The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.
November 21st 2024
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
The Importance of Leachables and Extractables Testing for a Successful Product Launch
January 2nd 2008FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.
20th Anniversary Special Feature: The transformation and future trends of laboratory data management
January 1st 2008Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.
Preparation and Characterization of Meloxicam–Myrj-52 Granules Obtained by Melt Granulation
December 2nd 2007Various manufacturing techniques can improve a drug's solubility, thus increasing its bioavailability. The authors examined whether melt granulation can enhance drug solubility using meloxicam as the drug substance and myrj-52 as the binder.
What's Next In: Analytical Testing
December 2nd 2007Industry and regulatory organizations agree that the current focus on product quality will play a major role in shaping pharmaceutical development in the future. Key to this assessment of quality are the methods and technologies in pharmaceutical analytical testing.