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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 01, 2016
Multiple methods are required for detecting and removing protein impurities.
July 28, 2016
NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.
July 26, 2016
July 22, 2016
The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.
The Nexera-i MT from Shimadzu incorporates two flow lines, which allow for both UHPLC and HPLC analysis.
July 19, 2016
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
July 12, 2016
EAG Laboratories announces new company identity and intent to expand testing, analysis, and characterization capabilities across multiple markets.
July 06, 2016
The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.
July 02, 2016
Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.