Biopharmaceutical Analysis: LC-MS

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

The authors present the results of a survey of biologics manufacturers to evaluate how these manufacturers transfer analytical methods.

Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.

USP evaluates raw materials used in the chemical synthesis of peptides.

By providing information on the relative accessibility of locations within a protein, HDX by mass spectrometry opens new windows into the higher order structure of biomolecules.