Manufacture of APIs using Enzymes Quality and Safety Aspects

5 Manufacture of APIs using Enzymes Quality and Safety Aspects 

Enz5mies sourced from vendors should come with a certificate of analysis (CoA) that provides information regarding specifications. Typical specifications on a CoA include physical form (solid, liquid, or suspension), appearance (color), and, most importantly, a specific activity measurement (U/ml or U/ mg protein), which ideally would be measured on the substrate of interest. A BSE/TSE statement is a standard requirement for material used in c-GMP manufacture of pharmaceuticals and certainly applies in the case of enzymes. 

Potential Enzyme-Related Impurities and Purge Strategies 

The main adverse events reported for industrial enzymes were occupational asthma and allergy, and irritation of skin, eye, and mucosal membranes related to enz5mies developed for the detergent industry. 

DNA from the host cell used to produce the enz3mie is a potential impurity, but the risk of orally ingested DNA is considered to be very low as humans t)q)ically ingest a significant amoxmt of DNA in their diet, and dietary DNA has not been 

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