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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, 2019
A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.
A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.
Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.
To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.
Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
August 01, 2019
A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.
Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.