Wheeler Bio is a biomanufacturing pioneer founded by a team of industry experts and strategic investors who believe a different CDMO model is needed for innovators to bring new therapeutic leads to the clinic faster, without the risk and cost associated with traditional outsourcing models.

Oklahoma City (OKC) is an innovative biohub with an established biomanufacturing industry and clinical research network. Wheeler has built and operationalized state-of-the-art development labs and cGMP manufacturing facility in the heart of OKC. Wheeler leverages powerful partnerships to offer a purpose-built development and manufacturing solution with a tremendously talented and experienced team to deliver our clients from discovery to the clinic and beyond.

Too often, innovators and their outsourcing providers have competing timeline horizons, budget expectations, and business priorities such that not all CMC (chemistry, manufacturing and controls) aspects are fully considered until it is too late. This can lead to delayed IND submissions or a clinical hold letter from the FDA, ultimately resulting in serious financial loss for innovators or even program failure. We believe these life cycle challenges can be alleviated with a modular approach from discovery to the initiation of Phase 1 clinical trials.

Modular CMC is a mammalian cell culture-based drug substance manufacturing platform that reduces timelines and regulatory risks through the introduction of QbD (Quality-by-Design) principles earlier in the drug development life cycle.

Partnership defines Wheeler

Wheeler's partnership culture is built on core principles including teamwork, accountability, and timely transparency.

Teamwork encourages collaboration, where individuals bring their unique strengths and perspectives to work together toward common objectives.

Accountability ensures that each person takes responsibility for their role and actions, fostering a sense of ownership and reliability.

Transparency supports open communication, where all parties are informed, involved, and can rely on honest and clear exchanges of information in a timely manner.

Together, these principles create an environment where partnerships thrive, as they cultivate a strong foundation of trust and shared responsibility, enabling teams to align, overcome challenges, and achieve collective success.

Wheeler Bio has strategically forged collaborations with a diverse array of industry leaders. These partnerships have enabled us to leverage cutting-edge genetic design and engineering capabilities, novel bioprocessing techniques and purification technologies, supported by state-of-the-art analytical technologies, empowering our team to deliver a faster, more reliable CMC solution for our innovative clients.

Wheeler’s culture embraces open communication and integrity. Employees aim to be authentic in every interaction and operate at the highest ethical and quality standards. This foundation is enhanced by a layer of digitalization tools that allow advanced data sharing, arming customers with instant insights for making critical decisions. Real-time, cloud-based data monitoring puts the customer on the development bench with Wheeler scientists for the ultimate collaborative CDMO experience. A rigorous project management approach ensures clarity of project status, routine customer contact, follow-ups, feedback, and rapid escalation routes.

Our deep experience with antibody drug substance process development and manufacturing enables Wheeler to offer more predictable project scopes, timelines, and budgets through our Modular CMC approach.