By Nigel J. Smart PhD, Managing Partner, Smart Pharmaceutical Consulting

Published on on Tuesday, January 15, 2013

Biotherapeutics require specialized manufacturing approaches when compared to synthetic chemical entities because the process used to synthesize the 3-D structure of the molecule defines its pharmacological activity and its associated value as a medical product. In practice, this involves the culture conditions of the host organism used to express the molecule and potential changes that may occur to the chemistry of the active components during recovery and purification. These changes can include both conformational changes in the structure as well as alterations due to protease and other enzymatic action. In these cases, moieties can be clipped selectively from the tertiary drug skeleton, or changes can occur in the degree of glycosylation due to enzymatic or chemical hydrolysis. Individually and/or collectively these can have a profound effect on the pharmacological activity and bioavailability of the drug.