August 11th 2025
The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.
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.
Novartis Recommends Against Its High-Dose Diabetes Drug
November 8th 2007Submitting a safety update to European regulators, Novartis provided data showing its 100-mg once-daily dose of ?Galvus? (vidagliptin), an oral type 2 diabetes treatment, has more frequent liver enzyme elevations in patients than its already approved 50-mg once- and twice-daily doses.
Preventive maintenance strategies for the pharmaceutical industry
November 1st 2007Maintenance and service-related items are often the second-largest budget element in a laboratory after salaries and benefits. Within maintenance, preventive maintenance (PM) is a substantial portion of the budget. Traditionally, PM was an equipment maintenance philosophy based on replacing, overhauling or remanufacturing a piece of equipment at fixed intervals, regardless of its condition at the time. In essence, it involved fixing something that wasn't necessarily broken and this approach is still widely used in the pharmaceutical industry.
The Application of Quality by Design to Analytical Methods
October 2nd 2007To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs. This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).