Mass spectrometric methodologies for the analysis of biotechnologically produced protein pharmaceuticals

The biotechnological production of protein pharmaceuticals is: i) initially a research problem, to which Chemistry is essential; ii) second, a problem of "quality control". The concept of "quality control" in terms of biotechnological products is quite different from the control of traditional products as there is still no history of the safety of the long term effects of these products in man. The "quality control" of a biotechnological product refers both to the individual production process and to the product itself. The methods for "quality control" can very greatly for two different processes, even if they lead to the same product. The "quality control" of a biotechnological product is concerned above all with the following: i) development and characterization of the production of recombinant organism; ii) culture and fermentation control, including the control of all equipment and product used; iii) control of the recovery and purification processes; iv) structural control of the final product. Mass spectrometry, belonging widely to the chemical sciences, plays an important role in biotechnology because of its capability to set-up several fast, sensitive and specific analytical and structural methods, which are invaluable for the full characterization of proteins, representing the ultimate objective of genetic manipulation. This paper review some recent studies concerned with the extensive use of mass spectrometry for the structural analysis of recombinant proteins of pharmaceutical interest.