More than manufacturing: The value of a patient-centric CDMO

What is a contract development and manufacturing organisation (CDMO) responsible for? And who is their core client? The answer to that question has been shifting in recent years. As an industry, we continue to take pride in our cost-efficient manufacturing, scalable facilities, and the reliable delivery of products on time and in full. We make the drugs and execute on our contracts. And increasingly, the traditional partnership model between sponsors and CDMOs has been evolving as sponsors appreciate the value of a partner that recognises the greater purpose of the work we do: serving the needs of patients.

A CDMO championing a commitment to patients may sound like lip service or branding, but truly patient-centric CDMOs offer differentiated services, more flexible batch sizes, and make tough decisions when it’s in the best interests of the patient.

Flexible services for distinct patient needs

With pharmaceutical manufacturing, the primary goals are always safety, efficacy, and reliable supply. These are non-negotiables; however, it’s important for CDMOs to recognise that these products don’t exist in a vacuum. The patients aren’t theoretical; they’re real people with real lives and families. Therefore, when considering our success and the potential of an active pharmaceutical ingredient (API), we must also consider its practical application in the real world.

Historically, the formulation strategy and dosage form design are determined by the biopharma sponsor, rather than the contract manufacturer. There’s a prevailing idea that science and the strategy are the sponsor’s domain, while the CDMO focuses on the manufacturing and execution. We actively challenge this separation as we have seen firsthand how we can do better, together, for the benefit of patients.

Wherever possible, we strive to be active participants in the dosage‐form design, working to understand patient needs and offering a range of tailored solutions. Even a standard oral solid dose (OSD) can be transformed with innovative delivery technologies. Pills can be coated to avoid a bad taste in the mouth or manufactured as chewable or mini-tablets for individuals – potentially children – who have difficulty swallowing pills. Integrating 3D printing technology into manufacturing operations can also enable easy-to-swallow medications, enhancing API bio availability while reducing adverse effects. For complex OSD therapeutics, cutting-edge drug delivery techniques such as continuous-flow extrusion-spheronisation can support a broad range of controlled-release dose forms, including fixed-dose combinations (FDCs), combined and modified-release single-capsule forms, and multi-unit particulate system (MUPS) tablet designs. It’s well-documented that incorporating patient preferences into a drug’s design can improve adherence and outcomes, while lowering downstream costs. Combined with easy-to-use, accessible packaging, these small design advantages can ensure patients gain the maximum benefit from their medicine.

Dosage designs are just one example of CDMO services that should be viewed through the lens of patient needs and constraints. In our experience, it’s also important to offer flexible batch sizes, which can be tailored to the needs of rare diseases and semi-rare diseases. Less directly, maintaining a robust supply chain helps to prevent delays or shortages of critical medications.

Shared decision-making

Along with external services, a patient-centric philosophy needs to be lived every day throughout the organisation. We need to ensure our team keeps the patient front-of-mind – even when that adds a mental and emotional burden to the work.

In recent years, the introduction of autologous cell therapies has underscored this reality. These treatments involve harvesting a patient's immune cells, which are then engineered, expanded, tested, and reinfused to help the individual combat a late-stage cancer. Each batch corresponds to one individual, and often a patient’s life is at stake. The engineering and manufacturing process has to be successful, as there is often only one chance at the starting material and the patient has limited time. It’s a constant reminder for everyone in the organisation that manufacturing biopharmaceuticals is not just work; real lives and loved ones are at stake.

Autologous or n-of-1 treatments are perhaps the most confronting example of the direct connection between manufacturing and patient outcomes. However, it’s always a factor in biopharma manufacturing. As the President of a CDMO, I strive to reinforce the patient connection and have it inform our decision-making at all levels of our organisation. It’s an added responsibility, but it’s the real meaning in our work. For example, we have a tradition at several of our facilities of hosting “Patient Highlight” events, where a patient who is using the medicine we manufacture at the site visits in person to share their story and the impact of the therapy on their lives. These events have had such a profound impact on our teams’ work and purpose, that they continue to request them.

As an industry, we must maintain a patient focused mindset as our centre and allow the benefits of operating in this industry to come from that perspective. If we immediately place our focus on things like competition and purely on financials it becomes very difficult to work our way back to the patients relying on us.

A patient-first mindset makes a tangible difference in how we operate. We don’t over-extend or compromise our safety protocols to win business or deliver on an impossibly short timeline. That’s not in the best interests of the patient or our partners. Conversely, if there are speed bumps or delays in the drug development journey, we work with the sponsor to help solve them. Being able to navigate development challenges to improve the process development pace to the benefit of patients is paramount during drug discovery and development. If a CDMO has a shared responsibility and accountability to your patients, they will always be in your corner, working to deliver on your drug’s therapeutic potential.

Finding a patient-centric partner

In our experience, the biggest misconception about CDMOs is that patients don't matter to our organisation. There’s an assumption that only a sponsor thinks about the patient, while the CDMO focuses on the process. We are viewed purely as a development and manufacturing engine, as part of a transactional deal. This may be the case for some CDMOs, but in our experience, it doesn’t deliver the best results for anyone, and it is not how we choose to operate.

For a biopharmaceutical company, contracting a CDMO that considers itself accountable to the patients can deliver a tangibly different experience. It means that when issues arise, the CDMO leans in and works with the sponsor to solve them – even when it’s not contractually required. They’re not executing on an MSA; they’re helping deliver treatments to patients. With that mindset, they’ll be a true partner through the ups and downs of the development journey.

About the author

J.D. Mowery brings nearly 25 years of leadership experience in the CDMO and biopharmaceutical industries, with a strong track record of driving innovation, growth, and operational excellence. Before joining Bora, he served as CEO of KBI Biopharma and Selexis SA, where he successfully led global CDMO operations across multiple continents. His expertise spans end-to-end pharmaceutical operations, including manufacturing, tech transfer, facility construction, business development, and sales and marketing. Throughout his career, Mowery has contributed to the success of some of the industry’s most respected companies, including Genentech, Celgene, Juno Therapeutics, Treadwell Therapeutics, and leading CDMOs such as Lonza and AGC Biologics.