CHALLENGES IN PURIFICATION OF BIOPHARMACEUTICALS

The biopharmaceutical industry is one of the fastest growing sectors in the global economy. Proteins
constitute an important class of biopharmaceutical products, but also have food and biotechnology
applications.3 Over the last 25 years, advances in recombinant DNA and hybridoma technologies
have permitted the large-scale production of virtually any protein by fermentation routes at increased
titers,4 thereby shifting the bottleneck in biopharmaceutical process development to the purification
of protein products from biological feed materials.5,6 This is widely recognized to be technically and
economically challenging, accounting for a substantial fraction of the total manufacturing cost. The
biopharmaceutical industry has been challenged to develop better (higher quality or safer) products
faster and at lower cost.

One way of achieving this goal is to complement the current process development paradigm by
investing in the many new and emerging analytical and scientific tools that have paved the way for
more systematic and rational strategies to process design and development. In the chemical
engineering domain, separation process synthesis and design methods and tools developed over
recent decades have reached a level of maturity that has provided advantages to industrial
practitioners as well as in academic process design.

The need to purify a protein efficiently, economically and to sufficient purity and quantity applies to
every large-scale protein purification process. The extent of purification depends on the end-use of
the protein product. So, from the downstream processing point of view, it is important to know the
application of the protein of interest. Commercially available proteins can be classified into food and
food additives or nutraceuticals; pharmaceuticals or therapeutics; industrial enzymes and diagnostic
enzymes.

Reference:

[1] T. R. Ahammad, S. Z.; Gomes, J.; Sreekrishnan, “Wastewater treatment forproductionofH2S-

free biogas,” J. Chem. Technol. Biotechnol., vol. 83, no. May, pp. 1163–1169, 2008, doi:
10.1002/jctb.