Bob Holt, Biocatalysis Director, Piramal Pharma Solutions
All aspects of the drug development process are highly regulated in order to minimize risks to quality and reproducibility of pharmaceutical products. As a result, drug manufacturers face a long and arduous process to commercialize a drug, leading the pharmaceutical industry to be skeptical of, or even reject, innovative new approaches to drug development. The risks associated with straying from what has been tried and tested are often believed to outweigh any potential benefits a change might offer.
Nonetheless, it is in the best interest of manufacturers to do their due diligence when considering new methods that could offer the increased efficiency they desire. One growing area of interest where some remain skeptical is biocatalysis, which is simply the use of biological catalysts (enzymes) rather than conventional chemical catalysts or reagents to carry out synthetic reactions. But why use enzymes when conventional chemistry has been carried out for decades using simple reagents like strong acids and iron filings? The main reason can be summarized in one word — selectivity. To date, the main application of biocatalysis has been to address problems of stereoselective synthesis, but enzymes demonstrate two further elements of selectivity of interest to those synthesizing complex molecules: regioselectivity and chemoselectivity. In addition to these three aspects of selectivity, another advantage of enzymes is that they can operate under mild reaction conditions, which requires less energy input and hence contributes to the “green” credentials of biocatalysis.
Biocatalysis is not intended to replace conventional chemistry; instead, biological catalysts can be used alongside conventional chemistry and applied where it offers advantages. Yet, misunderstandings in the pharmaceutical community about the capabilities and limitations of biocatalysis are giving way to hesitation about its adoption. By recognizing and dispelling the myths associated with it, a manufacturer can reap the benefits of biocatalysis, providing a route to greener, safer chemistry that delivers a higher overall yield and reduced cost by virtue of the exceptional selectivity of enzymes.
Below are some of the myths about biocatalysis, which are, in some quarters of the industry, limiting the rate of adoption of this valuable technology.