Building Better Biologics: A Challenge for the Biopharma Industry

(DGIwire) – Biologic drugs are playing an increasingly greater role in the toolkit of healthcare providers in the 21st century. But as a recent article on noted, a variety of pressures are pushing the pharmaceutical industry toward more streamlined ways of manufacturing their products as demand for them grows. For example, biologic drug development has traditionally depended on the use of Chinese hamster ovary (CHO) cells, reports the article. This is a scenario that some feel is ripe for change as some industry observers note drawbacks to this traditional paradigm.

“The CHO expression system has certain limitations that are particularly evident as the industry looks toward the next wave of biologics,” says Mark Emalfarb, President and CEO of Dyadic International. “The relatively low yields and relatively high costs of producing biologics with CHO appear to make it less sustainable for producing these more complex molecules.”

One cell source that Dyadic is exploring as the basis of a new drug manufacturing system for biologic building blocks is the fungus Myceliophthora thermophila, named C1. The company has been developing C1 for the past two decades, notes; research studies have shown the ability of C1 to scale up the rate at which enzymes and other proteins can be produced.

For these reasons and others, notes, C1 is said to represent an innovation in biologic drug development. Emalfarb envisions an era in which C1 will serve as a safe and efficient drug manufacturing system that can help speed up the development, lower the production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales.

Emalfarb is also a firm believer in C1’s ability to enable the development and commercialization of genes that are difficult to manufacture at reasonable volumes in CHO as well as in E. coli and other cell lines.

“The C1 expression platform may offer the biopharmaceutical industry potentially significant time and cost savings at each stage of cell development and manufacturing when compared to CHO cells,” Emalfarb adds. “As the world of biopharma looks toward the future, it might just decide that C1 could represent a promising alternative means of production to what is currently in place.”