Seeking a better process for making heparin, Ginkgo teams up with Ohio-based biotech – Endpoints News


The manufacturing process for biosynthetic heparin, a drug used to prevent blood clots, is not particularly clean.

In a slaughterhouse, someone has to remove the guts from a pig. The mucous membranes are then scraped. The steps to get heparin are huge and the process is complicated.

“It’s not like you kill a pig and have heparin,” said Keith Kleeman, CEO of Ohio-based Optimvia. Terminal News in an interview. “It’s a filthy, disgusting place to start a drug. I can’t think of a more disgusting place to start an important drug.

Jason Kelly

But Optimvia and Ginkgo Bioworks will team up to try to improve this process. The two companies announced last week that they will partner and leverage Ginkgo’s cell and enzyme engineering platform and fermentation process to strengthen the supply chain, make the drug more affordable and simplify the process.

Heparin is classified as an essential medicine by the World Health Organization, and producing non-animal versions of the drug is part of Optimvia’s goal. Enzymatic manufacturing has two big benefits: the extraction of a cleaner product and the creation of a more robust drug supply chain, Ginkgo CEO Jason Kelly said in an interview.

“It’s a cleaner product, your failure effects don’t pull anything weird out of the pig, you have a more confined production environment when you only have one species of cell producing this product in a tank , which the biotech industry learned with all the protein in the 1980s,” he said. But the second thing is how to have stronger supply chains for essential drugs. The more we “We can ferment things, the stronger the US supply chain. We can ferment things here. We’re good at it.”

That’s important for several reasons, but perhaps none more than that: There are currently 350 million pigs needed to meet global demand, Kleeman said, and somewhere between 60% and 80% of pigs found in slaughterhouses in China. The lack of geographical diversity means that any change in trade regulations could spiral supply out of control, and if something biological were to happen – such as an outbreak of mad cow disease or African swine fever – hundreds animals could be killed, and the prices of active pharmaceutical ingredients could skyrocket.

In 2008, contaminated heparin made in China killed 81 people in the United States and seriously injured 785.

The manufacturing process is similar to efforts by American automakers to replace the carburetor with fuel injectors in the 1980s. The people who created the carburetor failed to perfect the fuel injector, Kleeman said, and what helps Ginkgo and Optimvia in their efforts to improve this process is the distance it already has with it.

“We’re not the first to look at this, people have been looking at this since 1990, and they’re still trying to figure it out. So without giving the keys to the realm…we found a very critical component of the biosynthetic process that was already in play … (Scientists) haven’t cracked this natural process reproduction code… So why us? Well, we looked at it from a different angle.

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