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Human albumin is a major product of the fractionation of human plasma, with a long history of clinical use. While the manufacturing process of human albumin solutions has not undergone significant changes, these products have benefited from progress in pharmaceutical technology, quality control and quality assurance, which enhance their clinical safety. Besides the strict requirements of pharmacopoeia monographs which describe the minimal quality criteria with which products must comply, the quality of the final products relies on a careful in-process control, to guarantee the applicability of validated manufacturing processes and to prevent risks of chemical, bacteriological, viral or endotoxic contamination of the product. The development of new analytical methods for quality control and/or their increasing sensitivity also contributes to the improvement of the quality of these products. |
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