What is it about?
Degradation products in active protein ingredients (APIs) and finished pharmaceutical products are considered as impurities and it is required that these degradation impurities are minimized or rather avoided throughout manufacturing process. This study explored the occurrence of rSK degradation during acidification step in downstream processing. The existence of such degradation products in a drug product, to the extent which does not meet the necessary threshold, is not desired according to the international standards and regulations.
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Why is it important?
Degradation products ought to be minimized during production of recombinant proteins. We showed that the process conditions can affect the emerging of these degradation products of a recombinant protein and defining of specific downstream processing conditions before scale-up process is very crucial for minimizing of such degradation product in final active protein ingredients.
Perspectives
Degradation products in active protein ingredients (APIs) and finished pharmaceutical products are important concerns and need to be minimized or avoided throughout manufacturing process according to the international standards and regulations. Degradation of recombinant streptokinase (rSK) during downstream processing has not been reported before, and the current manuscript indicates and reports their emerging for the first time. The findings reported in this paper are of high importance, indicating and reporting the formation of rSK degradation products at certain conditions during downstream processing. Actually, as these degradation products have similar characteristics to the “natural rSK product”, their separation from the natural product is very difficult. Our previous published work explains the ease and difficulty of rSK purification at various pH values of solubilized rSK inclusion bodies at large-scale, without knowing the actual reason. The investigation reported in the current manuscript proved that the impurities emerged in the chromatographic purification of rSK at some pH conditions are actually “degradation products of rSK” making the process of purification tricky.
Dr Reza Jalalirad
Pasteur Institute of Iran
Read the Original
This page is a summary of: Exploration of Recombinant Streptokinase Degradation Products Under Various pH Reduction Conditions in Downstream Processing, Recent Patents on Biotechnology, March 2016, Bentham Science Publishers,
DOI: 10.2174/187220830902160308194812.
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