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Building Tomorrow’s Biologics: Could a Fungus Change the Status Quo?

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By Staff Reports

(DGIwire) – Every pharmaceutical company would like to make its production processes more efficient and cost-effective. According to a recent article in BioPharma Reporter, this includes the makers of biologic drugs noting that most companies in this space have long made their biologics using a method involving the Chinese hamster ovary (CHO). But one leader spotlighted in the article, Mark Emalfarb, President and CEO of Dyadic International, says it is time to realize the limitations of CHO and look beyond it to explore newer and potentially more efficient drug production methods.

“CHO cells have played an important role in the manufacture of revolutionary drugs for so many diseases. Yet as production needs ramp up, it might be worth exploring other manufacturing methods,” Mr. Emalfarb says. “One alternative that has shown promise involves the use of a genetically modified strain of fungus.”

Dyadic has harnessed its genetically modified strain of the fungus Myceliophthora thermophila, known as C1, as the basis of a proprietary platform designed to enhance the production of the proteins and enzymes that could be used to create vaccines, antibodies and other biologics.

To develop C1, Dyadic’s scientists exposed the cells of this species of fungus to UV light. They expanded and reinforced beneficial mutations to drastically change the shape of C1 from long, spaghetti-like strands to short, grain-sized sections. Since C1 fungal cells secrete enzymes from the ends of the filaments, there were more secreting ends, multiplying the potential total yield of enzymes. Furthermore, due to its new shape, C1 became easier to grow in large tanks.

Dyadic’s expression platform has already shown in the biofuel space that it can produce industrial enzymes at up to 100 grams per liter and about 80 percent purity and the company and certain biopharma company collaborators believe C1 can achieve high yields and purity in biopharma. The goal is to produce a quantity of drug—such as a monoclonal antibody (mAb)—in a fraction of the time it takes to produce the same drug using CHO cells at a much lower cost. If successful, C1 has the potential to be used to help speed up the development and significantly lower the cost of biologic drugs.

“The biologics market is expected to continue to grow rapidly and companies that are considering the most cost-efficient and productive manufacturing methods will be ahead of the game,” Mr. Emalfarb adds.

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