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Mark Emalfarb

President and CEO, Dyadic International, Inc.

New technologies and manufacturing approaches could help make vaccine development more affordable and accessible for a global population.

The challenge in creating vaccines to tackle a pandemic scenario lies in making them affordable and accessible for a global population. While higher income nations can fund development, purchase and distribution for their populations, cost remains an issue to low-and-middle income countries.

But industry expert Mark Emalfarb believes the key to a more rapid, equitable and cost-effective solution lies in new technologies and better manufacturing approaches for the way proteins are created for vaccine development.

COVID challenges

COVID-19 exposed weaknesses in vaccine development, access, supply and distribution in both developed and emerging nations. This, he believes, can be addressed by enabling all countries to produce their own affordable and effective vaccines and antibodies.

Using widely-available and economical products – such as aluminium hydroxide (alum) as an adjuvant, with an antigen and saline – with readily available and cost effective microbial fermenters, can deliver faster, more-effective and equitable vaccine solutions, he says.

Protein production platform

Mark Emalfarb is CEO of Dyadic International, which has developed the C1 protein production platform to shorten the time to develop and manufacture unparalleled amounts of affordable recombinant protein vaccines doses and antibodies using standard microbial fermentation vessels at flexible commercial scales.

The expression system, based on the fungus Thermothelomyces heterothallica will help combat pandemics and address health inequity, in addition to increasing vaccine and therapeutic production and supply.

Biological outbreaks

His company has explored how the technology can be deployed for pandemics and biological outbreaks over several years, including participation in the ZAPI (Zoonotic Anticipation and Preparedness Initiative) programme.

The programme has set up tools and platforms ready to be put into production for vaccines and monoclonal antibodies to counter emerging infectious diseases.

“When the COVID pandemic came, we already had the capabilities of satisfying a global demand for antigens which are used in recombinant protein vaccines,” he says. He describes it as “unfortunate” that this solution “did not receive the attention and funding” to combat the COVID-19 pandemic.

COVID-19 exposed weaknesses in vaccine development, access, supply and distribution.

Preparing for future pandemics

A vaccine development platform supporting preparedness for future pandemics empowers developing nations to make their own vaccine in situ because it is transferrable. As a result, they can be less reliant on industry, he explains.

The C1 technology, which has no endotoxins, can make ‘massive amounts’ of antigens and can be coupled with alum, a time tested adjuvant which has been used for decades even in children vaccines.

“As all countries have access to alum and standard E. Coli microbial fermenters it is the logical choice,” says Emalfarb. “The idea was to keep it simple and affordable so it can be manufactured in middle and lower income countries, as well as in the EU and US.”

Therapeutic treatments

Beyond COVID-19 vaccines, the platform has the potential to produce many other necessary vaccines and antibodies for infectious diseases such as HIV, influenza, malaria, HPV, rabies, West Nile virus and Zika.

The C1 platform is amenable to make monoclonal antibodies and other therapeutic treatments faster, in larger quantities more affordably,” he says. “You put in a DNA sequence and out comes a protein; it can be an antigen for vaccine or monoclonal antibody to treat disease.”

Alternative space

Emalfarb acknowledges that his organisation needs partners in big pharma organisations but underlines that the technology will “help the world get access and affordability to vaccines and treatments.”

“We hope to empower the world to sustainably produce its own biological products, whether they be antigens for vaccines, antibodies for therapeutics or other types of drugs so they can take their destiny into their own hands and not have to solely rely upon industry to take care of their citizens.”

Dyadic is looking to out-licence the C1 technology platform, and underlines it is scalable, easy to implement and cost effective, using existing standard equipment such as stainless-steel microbial fermenters or single use bio-reactor bags.

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