This case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.
The authors present a review of the techniques commonly used for glycosylation analysis.
Industry experts discuss the development of process chromatography in bioprocessing.
Biopharma and contract providers must tread carefully amid changing market dynamics.
Better process development is creating industry benchmarks for bioprocessing.
Contract manufacturers are essential players that allow biopharmaceutical companies the flexibility to address fluctuating product demand and the ability to outsource projects that are not strategically critical..
The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.
Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.
The new executive director of the European Medicines Agency begins appointment.