Biopharmaceutical manufacturing has been stretched thin for the past two years, limited both by capacity and a lack of standardization that makes it challenging to transfer technology and scale manufacturing among facilities, even within the same organization.
“Some of the more established lines are site or technology specific,” says Jesse McCool, PhD, co-founder and CEO of Wheeler Bio, a young contract development and manufacturing organization (CDMO). So, despite the many expansion projects around the world, manufacturing capacity remains limited.
By developing open-source manufacturing processes that integrate with the operations of traditionally siloed organizations, Wheeler Bio can partner with contract research organizations (CROs) early in the development process and ensure they have access to standardized processes that scale easily and that can be transferred to a broad network of CDMOs. For now, Wheeler Bio is focusing on the manufacture of monoclonal antibodies (mAbs). The company is building capabilities to support small-batch orders for preclinical development, toxicology, and early clinical supplies.
In total, members of the Wheeler Bio team have 150 years of experience in drug development and in cGMP compliance. McCool himself has 15 years of experience in the CDMO industry, having had technical and leadership roles at Lonza and Cytovance Biologics. The team understands “business as usual” and aims to create something better. By “better,” McCool means “better collaboration, better transparency, and true partnering, with shared risks and rewards.”
Bridging the CRO-CDMO gap
“There’s a gap between CROs and CDMOs,” McCool points out. “CROs, by and large, aren’t experienced in manufacturing, so we’re working with them to bring development workflows further upstream.” Such partnerships address any information gaps and enable CROs to go beyond drug candidate lead selection to further refine candidates based upon the eventual manufacturing technology, and to standardize drug development and thus streamline technology transfer for manufacturing.
To bridge the CRO-CDMO gap, Wheeler Bio developed the Portable CMC platform, a chemistry, manufacturing, and controls playbook for antibody therapeutics and, soon, bispecific antibodies and related modalities. Portable CMC supports parallel integration between service providers. Consequently, McCool says that customers can access manufacturing earlier and at lower cost, and thus determine whether the compound is manufacturable. Overall, this approach can shave six to nine months off clinical timelines by providing a more predictable path between drug discovery work and investigational new drug (IND) filings. That’s because the platform provides, in McCool’s words, “a clear line of sight to the manufacturing batch.”
Noting that bioreactors haven’t changed much in the past three decades, McCool asserts that the innovative aspect of Wheeler Bio’s approach is the combination of standard, robust manufacturing technologies; AI-enabled process development using off-the-shelf solutions; and business innovation. “The objective,” he insists, “is to democratize access to drug substance processes and reduce bottlenecks that delay biomanufacturing.”
Wheeler Bio suggests that its approach is unique. “There are no strings attached,” McCool explains. “Our partners can take the Wheeler Bio process to any CDMO in the world.” The idea is to expand the pool of CDMO candidates for any given compound. McCool emphasizes, “All the process parameters and all the raw materials are defined.”
Participating in regional development
“Oklahoma is looking to diversify beyond oil and gas,” McCool says, though that industry is still an important part of its economy. The co-founders paid homage to this oil and gas heritage—and the state’s pioneering spirit—with the company name. “Wheeler” refers to Wheeler Well #1 in Drumright, OK, which triggered the rise of a new industry for Oklahoma in 1912.
McCool has worked in Oklahoma since 2013, when he joined Cytovance. He eventually became Cytovance’s CEO, but left the company to pursue opportunities more aligned with his scientific interests. “Cytovance … was acquired by Shenzhen Hepalink Pharmaceutical in 2015, and [it] was shifting its priorities to commercial orders,” McCool recalls. “My interests are in developing novel medicines using cutting-edge expression and production technologies. I saw a growing need to help venture-backed biotech firms navigate the outsourcing silos and find ways to reduce friction on the way to the clinic. The only way I felt I could do that was to do my own thing.”
McCool founded Wheeler Bio to focus on emerging biotech companies that need small batches of preclinical and Phase I materials. Rather than return to the Boston area, his base during his time at Lonza, or pursue his fortunes in San Francisco, he chose to stay in Oklahoma.
“Oklahoma City has the potential to be a drug development city,” McCool maintains. “There are a lot of pharmaceutical services companies in this region.” Multiple research centers are actively engaged in translational science and clinical testing. “There are more than 50,000 employees in the metropolitan area (of 1.5 million people) who are connected to biotech,” he notes. “That’s a good critical mass of trained personnel.”
The region also presents funding opportunities. Local investors—former oil and gas executives—are excited about adding biomanufacturing to the state’s economy. Several have been recruited by McCool and Wheeler Bio’s co-founder, Christian Kanady, founding partner of Echo Investment Capital.
Finally, operating in Oklahoma is cost effective. “With recombinant protein manufacturing facilities growing globally at an exponential rate, there will be more batch pricing pressure,” McCool elaborates. “Low-cost cities in the United States, like Oklahoma City, will be able to sustain competitiveness.”
“The CDMO space is crowded, so we put a lot of research into identifying our niche, creating and modeling our business plan, and speaking with investors,” McCool says. The company is also turning its attention to the recruitment of clients.
Wheeler Bio’s first client is Alloy Therapeutics, a CRO based in Waltham, MA. Alloy’s mAb discovery services business uses ATX-Gx (humanized) mice and works with customers upstream from Wheeler Bio. The two companies are collaborating on process elements such as expression systems, media, and unit operations. They are also working to ease the transition from research to manufacturing by addressing manufacturing questions early in development.
Being a new entrant in a crowded space is difficult at any time, but Wheeler Bio launched during the pandemic. Like other biotech companies, it currently faces supply chain issues and rising prices for consumables and equipment. Contending with these challenges requires building ample contingencies into its models to account for delays, product constraints, or other complications. McCool says this instills agility and preparedness to respond to any future challenges.
Construction on a 35,000-square-foot GMP facility is scheduled to begin in July. It will feature two closed-processing drug substance lines, cell banking capabilities, and a process development laboratory. Wheeler currently has a 3,500-square-foot cell development laboratory at nearby University of Oklahoma Research Park and an R&D laboratory inside Alloy Therapeutics.
“The market is excited about biomanufacturing,” McCool declares. “CDMOs complement a venture capital portfolio, so we didn’t have trouble raising seed money.” The company closed a $14 million seed round in January. He anticipates closing a Series A round in the second quarter.