From Jeans to Genes

No matter what the top designers make of them, harsh dark denims never really catch on. Stonewashed jeans feel better, look better and are simply a cool wardrobe staple. But the secret behind them is more than just cool, it is revolutionary. Like the revolutions gone-by, the march of scientific progress is much like the march into battle.

Imagine for a moment that you had found a way to address the world’s needs to produce cheap and highly effective products that help to feed, fuel, and heal humankind? Would you be branded an innovator and embraced by the industries of the world, or would you be treated as a threat and attacked from all directions? If your name is Mark Emalfarb, you have experienced both.

Mark Emalfarb is the founder and CEO of the publicly owned, Dyadic International Inc.  Emalfarb turned a successful stone wash jeans business into a global biotech company, which has the ability to turn genes into revolutionary pharmaceutical products.

In the 1980s, the faded stone-wash effect used by the likes of Wrangler and Levi was pioneered by Mark Emalfarb using pumice stones. Instead of multiple washes with pumice, it soon became apparent that the job could be done in a more environmentally friendly way using enzymes.

In the early-1990’s, Dyadic scientists discovered a novel fungus, Myceliophthora thermophila, deep in the undergrowth of forests in the Russian Far East. This fungus produces cellulase enzymes, which are ideal for developing technologies for a wide range of industrial applications. Like the fungus Penicillium chrysogeum that was used to produce penicillin, these enzymes required enhancing with mutation causing X-rays, to create a mutant strain that produced a high yield at low cost, which the company named C1. 

Furthermore, serendipitous mutations of C1 led Emalfarb to realize that the C1 technology was not just another interesting discovery, but a potentially disruptive platform technology that could take his business far beyond the realms of stonewashing genes. Its unique properties and highly productive and robust nature had Elmalfarb set for a four-decade journey through several industries and onto a new medical frontier.

For example, these enzymes can convert non-consumable agricultural fibre, like corn stover, into glucose that are fermented into fuels, like ethanol, thus also preserving precious starch foods like corn and wheat and reducing greenhouse gas emissions, as well as being made into plastics and polymers.

To date, Dyadic has achieved commercial success manufacturing the C1 technology for a diverse range of industrial applications, such as, biofuels, animal feed, materials, food and detergents. Dyadic successfully commercialized its C1 technology by developing its own products and entering into license deals with the big global players, Abengoa, BASF, and Codexis/Shell.  Emalfarb is also credited with closing the sale of Dyadic’s industrial biotech business to DuPont, one of the world’s largest enzymes producer, for $75 million in 2015. Today, the C1 technology continues to produce enzymes that help better feed and fuel the world.

Mark's daughter on top of his stonewashed jeans

With its successful commercialization track record, Dyadic is now moving into the global pharmaceutical market with the goal of harnessing its C1 technology to pioneer sought-after new treatments. Historically, the pharmaceutical industry flourished using synthetic chemistry to produce active pharmaceutical ingredients and drugs. However, the sequencing of the human genome has led to an explosion of genomic data and a multibillion dollar biopharmaceutical sub-sector which is developing and manufacturing products made from living sources, like cells, proteins, antibodies. Called biologics, they include a wide range of treatments, vaccines and drugs. “Biologics are the fastest growing segment of the biopharmaceutical industry and they command an impressive 21% of the pharmaceutical industry,” according to Emalfarb and sited in Transparency Market Research’s recent report on the Biologics market.

The industry standard for making biologics are age-old CHO cells, which come from the ovaries of Chinese hamsters. However, they were not originally produced for biologics and ended up being modified for the job in the absence of a better technology.  CHO cells are costlier and less robust, so this provides Dyadic a lucrative space to move into and the industry an opportunity to innovate (i.e. Samsung, Biogen and the Bill and Melinda Gates foundation are also developing such alternative cells).

“We believe our technology will be able to make biologics with five to ten times greater yield, in half the time and with a lot less cost than the CHO cells,” Emalfarb stresses. “This seriously changes the game in the way biologics can be produced.”

Dyadic are now applying their C1 technology as a platform to help bring biologic vaccines and drugs with improved drug properties to market faster, in greater volumes and at lower costs; thus, making them more accessible to patients and healthcare providers globally.

Not only does this provides Dyadic with the opportunity to tap into lucrative markets but also to make a real difference to healthcare around the world. For example, in developing and producing antibodies, Dyadic will be providing the ever-growing aging population with much needed anti-inflammatory drugs to treat rheumatoid arthritis. And for treating cancer these antibodies have the potential to attack tumour cells in multiple places (targeting different antigens) and in a more robust way than the standard CHO cells.

The threat of unknown and known diseases, provides huge scope for new preventative and therapeutic biologic vaccines. In the Third-world, which bears the brunt of infectious diseases like HIV, new biologics could possibly, just possibly, come up with the vaccine that has eluded the field for decades.  

The rate of change in the biotechnology industry is accelerating at breakneck speeds. In 2003, it was estimated to cost $50 million to sequence a human genome, today that has dropped to just a $1000. Scientists, the bio-tech industry and governments are mapping the genomes of just about every living organism in search of gene sequences that can be turned into biopharmaceuticals, which improve and prolong human and animal health. In pursuit of this, the field is developing ever faster, cheaper and more accurate molecular tools, like CRISPR/Cas9 gene editing.

Emalfarb sees a perfect fit here; by combining Dyadic’s prolific C1 industrial cell lines with these advanced molecular tools, there is an opportunity to introduce game-changing technology that has the potential to improve access to biopharmaceuticals while lowering their cost for patients and the global healthcare system.

With the world’s aging population growing, the demand for these expensive biologic vaccines and drugs has skyrocketed. “Together, these factors will run up a tab that cannot be paid by any one country or healthcare financing system,” says Dr Steve Arlington, global leader of Price-WaterhouseCoopers’ Pharmaceutical Industry Group. “Moreover, in its present form, the biotech and pharmaceutical industries are unable to produce innovative treatments, like biologic vaccines, quickly and economically enough to meet disease threats,” he adds.

Therefore, the biopharmaceutical industry and government regulatory agencies must embrace innovation rather than feel threatened by it, in order to make the health care system economically viable to patients and providers according to Emalfarb.

We are marching towards a Genomic revolution in medicine that is giving us the cutting-edge ammunition to fight previously untreatable conditions. Having already helped fuel the industrial world with an array of products, the work of this this novel Russian fungus is not yet done: healing mankind is its next frontier.