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March 02, 2019
HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.
March 01, 2019
Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.
February 02, 2019
Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
Leveraging vast quantities of analytical data requires digitalization and platform integration.
When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect.
Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.
February 01, 2019
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles.
January 31, 2019
SGS announces expansion of cell bank and bulk harvest testing services.
January 07, 2019
Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.