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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.
December 02, 2018
Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.
November 29, 2018
A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.
The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.
November 15, 2018
Industry–academia collaborations seek to address unmet needs in measurement science.
The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.
By reducing the number of assays needed and allowing product quality attributes to be measured end to end, MAM promises to allow users to gain product and process understanding much sooner than they could in the past, and to ensure quality and safety in a more efficient, streamlined way, throughout the product life cycle.
By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.
If a vortex mixer produces too much energy during sample preparation for particle size analysis, the size and morphology of particles can change. A study compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size distribution.
This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.