An International Quest to Make Vaccines and Drugs More Accessible and Affordable

(DGIwire) – In recent years, monoclonal antibodies—or “mAbs” for short—have emerged as preferred therapeutic candidates for the treatment of a multitude of disorders and diseases. These include a broad range of cancers, autoimmune diseases and microbial infections. Traditionally, however, antibody treatment has been extremely costly and not widely affordable.

Recently, an initiative of truly international proportions was announced that could improve this state of affairs. Dyadic International—along with the Serum Institute of India, one of the world’s largest vaccine manufacturers—have teamed up to develop and manufacture up to 12 antibodies and vaccines using Dyadic’s C1 vaccine and drug development and manufacturing expression platform. This important collaboration is focused on making biologic vaccines and drugs accessible and more affordable to patients worldwide while lowering the financial burden on the global healthcare system.

“Our goal is to offer our C1 gene expression platform to biotech and pharma companies as well as institutes and government agencies that are committed to reducing the cost of healthcare and saving lives,” says Mark Emalfarb, CEO of Dyadic. “The science and results to be achieved through this type of global collaboration could have a significant impact on the well-being of patient populations worldwide.”

Dyadic believes that the C1 technology represents an advance over other commonly used cell lines such as Chinese hamster ovary (CHO), E. coli, insect cells such as baculovirus and yeast, which for decades have been the industry standard cell lines used to produce biologics. According to Emalfarb, prominent among the promising alternatives to these commonly used cell lines is Dyadic’s own proprietary protein expression platform, which is based on the company’s proprietary genetically modified strain of fungus: Myceliophthora thermophila, named C1. C1 has shown promise in producing certain enzymes and other proteins in a shorter amount of time, in higher amounts and at a lower cost than these traditional cell lines. The potential efficiency of C1 as a protein production platform is significant, says Emalfarb. For example, the fungus’ unique shape translates into better growth conditions with higher yields of secreted protein and lower viscosity. In addition to requiring only low-cost synthetic media, C1 is also virus-free, eliminating the need for viral inactivation.

In addition to this, C1 cells can be grown under wider operating conditions, from pH 5-8 and temperatures ranging from 20°C to 43°C at scales ranging from 96-well microtiter plates to single-use bioreactors all the way up to 100,000-liter fermenters and above. These types of benefits are complemented by the shorter development and production cycle that C1 introduces. According to Emalfarb, it is possible to develop gram-per-liter-per-day C1 cell lines in as little as 15 weeks. Additionally, the C1 fermentation cycle time is in the range of four to seven days, which is about one-half to one-third the time required by CHO. This translates into a lower production cost both in terms of capital expenditure and operating expenditure, whether a facility uses 12,000-liter stainless steel fermenters or 2,000-liter or smaller single-use bioreactors. Capital expenditure is reduced by C1’s ability to produce biologic vaccines and drugs at higher yields in a shorter time at flexible commercial scales.

“C1 could become a platform of choice for manufacturing protein-based biologics and vaccines because of its speed of development and low cost of goods—a goal that could potentially benefit patients around the globe,” Emalfarb adds.

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