Protein biopharmaceuticals comparability studies

Once a peptide map is characterized using online MS, the chromatographic profile alone can serve as a routine analytical tool to monitor the protein s primary structure and covalent modifications, and is often used for batch release or stability testing of biopharmaceuticals. However, whenever in-depth characterization of a protein is needed, such as that required for comparability studies or reference material characterization, the peptide map should be coupled with MS to ensure a thorough examination of all peptides in the map. 

Further, a study has been conducted of the release of quinidine (common antiarrhythmic preparation) from various medicinal forms produced by immobilization of quinidine and its complexes with surface active substances or protein on HDS. On the basis of the results of the comparative analysis of the data of biopharmaceutic and pharmacokinetic researches it was inferred that the requirements to medicinal agents of prolonged action are most fully met by the preparation produced by coprecipitation of complexes of quinidine with molecules of serum albumin on the surface of HDS. Administration of this preparation does not give rise to any sharp peak of concentration of quinidine in blood and a slow decrease in concentration during a long term is observed. Besides, administration of this medicinal form makes it possible to provide the maximum bioavailability of quinidine. 

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