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For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive…
Biological products, usually referred to as biologics, constitute a significant segment of pharmaceuticals in development. Biologics include therapeutic proteins, antibody drugs, antibody-drug conjugates (ADCs), vaccines, carbohydrates drugs, blood and tissue-derived pharmaceuticals, gene therapies, even live cells and tissues...
Since the 1970s, the advent of biotechnology has resulted in the development and commercialisation of many therapeutic proteins, including antibodies and antibody fragments, for the treatment of human diseases. Examples include antibody treatments for autoimmune diseases (for example, adalimumab [Humira®] for rheumatoid arthritis), cancers (such as trastuzumab [Herceptin®] for breast…
