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There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.
Effective analytics will eliminate failures, deviations, and non-conformances.
August 02, 2017
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
July 27, 2017
A sampling of new laboratory equipment showcases streamlined operations.
July 18, 2017
Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.
July 05, 2017
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
July 02, 2017
Industry experts discuss how advances in analytical testing tools have helped address challenges in pharmaceutical analysis.
A bathless dissolution tester from Distek operates without a water bath and associated maintenance.
Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.
The more pharma science and technology change, the more business and policy concerns stay the same.
