Biopharmaceuticals are advancing healthcare at an unprecedented rate, yet the journey from groundbreaking drug discoveries to clinical use is fraught with complexities. These challenges, especially for early-stage biotech companies, often lead to what’s known as the "valley of death" — the perilous gap between drug discovery and clinical development. On a recent episode of ReSETTing Tomorrow, host Hugo Malan spoke with Jesse McCool, CEO and co-founder of Wheeler Bio, who is rewriting the playbook on overcoming these challenges. Through a unique mix of innovative technology, partnerships, and a commitment to accessibility, Wheeler Bio is setting a new standard in the industry.
Founded in 2021, Wheeler Bio focuses on a crucial mission: helping early-stage biotech companies overcome barriers to clinical readiness. As the industry navigates the high-stakes world of biologics, Wheeler Bio’s approach provides a lifeline for companies at risk of stalling in this critical phase. By offering efficient, cost-effective manufacturing solutions, Wheeler Bio empowers these companies to continue advancing their innovations toward clinical use without being hindered by scale-up and supply chain challenges.
Wheeler Bio’s model is grounded in democratizing access to essential biopharmaceutical services. Through a partnership-driven approach, Wheeler Bio works with biotech innovators to create a seamless pathway from the lab bench to clinical manufacturing. This integration of discovery and clinical supply chain processes ensures that promising therapies can progress smoothly, sidestepping the typical pitfalls of early-stage biotech development.
Jesse McCool’s passion for accelerating drug development has led Wheeler Bio to pioneer some remarkable advancements, each designed to streamline production timelines and reduce costs:
Stable Pools and Transposon Technology: Wheeler Bio leverages cutting-edge transposon technology developed by ATUM, known as Leap-In Transposase, to expedite DNA integration into cell lines. This breakthrough not only accelerates cell line development but also reduces production costs, making clinical manufacturing more accessible for emerging biotech firms.
Thermo Fisher Scientific’s DynaDrive System: This high-capacity bioreactor system scales biomanufacturing to meet growing industry demands, providing a solution that’s as adaptable to early-stage production as it is to commercial-scale operations.
Portable CMC Platform: Wheeler Bio’s open-source Portable CMC platform slashes pre-manufacturing timelines from the typical 6-9 months to just about 3 months. With substantial cost savings and an agile structure, the platform redefines readiness, giving companies a faster route to clinical trials.
Wheeler Bio’s commitment to accessibility extends to its open-source initiatives. The Portable CMC platform allows clients to access and build upon proprietary technologies and processes, promoting collaborative progress, especially in antibody development. This transparency ensures that clients retain flexibility, even as their needs evolve, supporting smooth transitions and scaling across all phases of development.
Jesse McCool emphasizes the importance of strategic partnerships in Wheeler Bio’s operations and influence. Through collaborations with both local and international players, Wheeler Bio is building an ecosystem that empowers small biotech companies to grow and thrive. A standout example is Wheeler Bio’s mixed-use facility in Oklahoma City, designed for mid-scale production and embodying the company’s vision of flexible, scalable biomanufacturing.
For Wheeler Bio, venture capital is more than just funding; it’s a catalyst for industry advancement. With a customer base largely composed of venture-backed companies, Wheeler Bio is positioned to support some of the most forward-thinking projects in biopharmaceuticals. This alignment with venture-backed innovators keeps Wheeler Bio at the forefront of biopharmaceutical developments, ensuring that novel therapies reach patients faster.
Attention to detail and execution precision are fundamental at Wheeler Bio. Their newly designed facility, tailored for first-in-human testing, exemplifies this commitment. The facility’s centralized “ballroom” layout supports regulatory requirements while promoting efficient workflows and compliance, making it a model of modern biomanufacturing.
As Wheeler Bio continues to evolve, it keeps a pulse on industry trends and legislative changes, such as the upcoming biosecure act, which may create a more competitive environment for Contract Development and Manufacturing Organizations (CDMOs). This awareness positions Wheeler Bio to stay agile and responsive to the ever-changing landscape of biopharmaceutical manufacturing.
Beyond technological achievements, Wheeler Bio places a strong emphasis on culture and values. Established from day one, these guiding principles drive hiring practices, daily operations, and the company’s overall mission. A cohesive, motivated team is at the core of Wheeler Bio’s success, providing the foundation for overcoming challenges and sustaining innovation.
With a focus on domestic manufacturing, innovative technology, and a commitment to supporting early-phase biotech companies, Wheeler Bio is pioneering a transformative approach in biopharmaceuticals. By bridging discovery with clinical supply and fostering an ecosystem of collaboration and innovation, Wheeler Bio is laying the groundwork for a future where life-changing therapies reach patients faster, more affordably, and with uncompromised quality. Under Jesse McCool’s forward-thinking leadership, the future of biopharmaceutical innovation looks brighter than ever.
Click here to listen to the entire episode of ReSETTing Tomorrow presented by Kelly Science, Engineering, Technology & Telecom.