OKLAHOMA CITY – Local biotech startup Wheeler Bio is poised to start manufacturing batches of molecules this fall, after settling into what it calls the facility of the future.
Wheeler Bio is a contract development and manufacturing organization, or CDMO, that specializes in batch clinical production of biologics and Good Manufacturing Process-grade, or GMP, reagents using an open-source platform.
The company, launched in 2021 by CEO Jesse McCool along with co-founder Christian Kanady, is a part of Oklahoma City’s growing biotech hub, housed in the 35,000-square-foot Ziggurat building in downtown Oklahoma City.
McCool and Kanady intend to accelerate the translation of therapeutic innovation into clinical effect.
According to an Oxford University journal article, Chinese hamster ovary cells are used widely for producing biopharmaceuticals, and engineering gene expression in those cells is key to improving drug quality and affordability.
The cells soon will be genetically engineered at Wheeler Bio. McCool said its small-batch manufacturing facility can fill a gap that exists between drug discovery and scale-up manufacturing.
A majority of the drugs in the pipeline going from the preclinical stage to phase one need only one batch, McCool said. That’s where Wheeler Bio as a small-batch manufacturer comes in.
“That’s what’s different about what we’re doing and we’re doing it in Oklahoma, so that you don’t have to go to China or India to do that,” McCool said. “You can get cheaper outsourcing from those countries, but there is a quality component that’s a risk and there’s also the travel to get there – it’s very expensive, so we’re trying to do something that’s different using and leveraging Oklahoma.”
According to the Wheeler Bio website, its “facility of the future” is designed to be highly flexible and accommodate a variety of biologics, which are medicines originating from living sources that treat conditions ranging from cancer to autoimmune disorders such as psoriatic arthritis and ulcerative colitis.
Wheeler Bio doesn’t make its own drugs. Rather, it acts as a service provider to an industry that’s growing rapidly.
BioSpace reports the global biopharmaceuticals market size was more than $333 billion in 2022. It’s expected to hold around $856 billion by 2030 with a compound annual growth rate of 12.5%
McCool has 20 years of pharmaceutical industry experience as part of companies both small and large, but said this is the first startup that he’s done himself.
He said many molecules are being developed by sponsors that can’t afford to build a facility that Wheeler Bio has. The company raised close to $45 million to build a series of clean rooms that make up about 10,000 square feet of its space. Since the drugs eventually go into humans, they must be made under GMP and Food and Drug Administration water regulations, and clean rooms ensure those conditions are met.
A chemistry, manufacturing and controls system is a quality requirement by the FDA. Wheeler Bio created a trademarked portable CMC system. McCool described it as an open-source platform. He said the portability means its customers have “access to their playbook.”
Some CDMOs have a proprietary platform they might not want to share, but McCool said when customers are done making a drug at Wheeler and they want to scale up to phase two or three, they can “take the playbook with them with no strings attached.”
In May, Wheeler Bio announced an agreement with Charles River Laboratories International, a contract research organization, to implement RightSource, a quality control platform, at its Oklahoma City facility.
The satellite lab will be operated by Charles River employees, using their established management systems, test methods and standard operating procedures to support quality control needs for Wheeler Bio and their third-party customers.
According to a Charles River annual report in 2022, the company has worked on more than 80% of the drugs approved by the FDA over the last five years.
“To have everything that we make tested by Charles River is a really important thing for customers to feel comfortable about what we’re doing here,” McCool said.
McCool said many of its customers are sponsors in the early stage of drug development that can’t afford to build the facility like Wheeler Bio’s.
“They spend their money on the (research and development), so everything is outsourced to partners like Wheeler (Bio), which is where the industry is growing,” McCool said.
Oklahoma’s advantages in the biotech space
While most of the industry is based out of San Francisco or Boston, McCool and Kanady say there’s a number of reasons why Oklahoma City makes sense for molecule manufacturing.
Kanady, an Oklahoma native who is also the founding partner of Echo Investment Capital, which oversees more than $1.3 billion in capital that includes Wheeler Bio, said the company serves as an industry collaborator with San Francisco and Boston, as opposed to a competitor, and international supply chain issues in recent years underscored a need for the ability to manufacture molecules in the U.S. as domestic demand exceeded supply.
Local partnerships here in Oklahoma also were considered. Kanady said they want to “leverage local competencies” such as the University of Oklahoma and the Oklahoma Medical Research Foundation.
McCool said being centrally located means they can bring drug developers through their system and coordinate introductions with the OU Health Stephenson Cancer Center, a nationally renowned leader in conducting clinical trials research for novel cancer therapies.
Low business operating costs is another advantage, McCool said. Wheeler Bio is headquartered in Oklahoma City, but has an R&D center at Alloy Therapeutics in Boston. Alloy Therapeutics, a drug discovery platform company, is one of Wheeler Bio’s partners.
McCool said the fundraising support in Oklahoma, a state that’s less accustomed to investing in biotech, has been strong, including Pine Ridge Ventures, Boyd Street Ventures and Echo.
Future goals at Wheeler Bio, leading local industry growth
As production starts this fall, McCool looks forward to having an effect on the industry and helping reduce the time it takes to get a molecule from the earliest stage to human trials.
The company employs 37 people right now, but McCool anticipates having a team of between 200 and 250 in five years.
“We want to fill up this facility in the next five or six years and then have another one coming online, and that building is already being built,” McCool said.
McCool is referring to The Convergence, a mixed-use development near NE Eighth Street and Interstate 235. Wheeler Bio will be a primary tenant of the 211,000-square-foot office tower that includes 50,000 square feet of lab space.
Kanady said Wheeler Bio could grow into a multibillion-dollar business and potentially employ thousands of Oklahomans.
“Once we start to manufacture molecules and biotech ideas that are coming out of esteemed institutions that are on the coast with super successful serial entrepreneurs that had three or four different exits to biopharma, we believe that this could be an incredible, attractive magnet where people start to take Oklahoma City more seriously in the biotech space,” Kanady said.
At a State of the City address last week, Oklahoma City Mayor David Holt said the city’s recent growth in biotech is “one of the most exciting new economic developments in the past year.” He said the federal government awarded a $35 million grant to OKC to support the growth of biotech.
“I recently toured the Wheeler Bio facility downtown,” Holt said. “Just literally a few blocks north of here, they’ll be manufacturing pharmaceuticals at the cutting edge of medicine, in the heart of downtown Oklahoma City. It’s really amazing and it shows the growing diversification of our economy.”
This content was originally published here.
