Quality First: Why CDMO Excellence Ultimately Depends on Trust
By J.D. Mowery, President, Bora CDMO Business
For CDMOs, operational excellence is often defined by three interconnected priorities: quality, speed, and flexibility. Sponsors rely on their CDMO partners to move programs forward quickly, adapt to changing development strategies, navigate obstacles efficiently, and deliver consistent, high-quality drug products at every stage. In my experience, achieving this balance starts with a clear understanding that speed and flexibility are only sustainable when they are built on a strong foundation of quality.
From formulation development to packaging and sterile fill/finish, quality is not simply about meeting specifications— it’s about ensuring reproducibility across batches, robustness across scales, and reliability across global supply chains. Formulation changes, scale-up activities, and technology transfers introduce risk if they are not supported by deep process understanding and well-controlled systems, both of which depend on a strong CDMO team. When quality is embedded into development from the outset, through thorough characterization, validated methods, and clear documentation, teams can move faster with confidence. Decisions are based on data rather than assumptions, reducing delays and minimizing the need for rework.
A CDMO partner’s flexibility is also ultimately dependent on quality. Sponsors frequently adjust timelines or manufacturing parameters as clinical programs evolve or market needs shift. A CDMO’s ability to respond effectively depends on standardized processes, attentive change management, and an established culture of quality. In small-molecule manufacturing, seemingly minor changes such as adjustments to excipients, equipment, or process parameters can have significant downstream effects. A mature quality system ensures that flexibility never comes at the expense of product integrity or patient safety. At Bora, our consistent quality framework across all sites and functions ensures every product, from prescription to over-the-counter drugs, delivers the expected therapeutic benefit.
Speed, in turn, is best achieved through consistency and proactive action. Facilities that prioritize right-first-time execution experience fewer deviations, smoother scale-ups, and more predictable regulatory interactions. Strong quality systems enable efficient tech transfers between development and manufacturing, support faster release timelines, and reduce the likelihood of unexpected interruptions. In this way, attention to quality is not a bottleneck but rather a catalyst for reliable progress.
Beyond systems and processes, quality is ultimately about trust. Every tablet, ointment, capsule, or sterile dose produced represents a medicine that improves the lives of patients, their families, and their communities. Bora’s guiding principle is simple: every employee should feel confident that they would trust any drug leaving a Bora facility for themselves or their family. This mindset shifts quality from a procedural requirement to a shared responsibility that informs daily decision-making. If we keep the goal of quality as our north star, quality-focused actions will ultimately fuel speed and enable flexibility.
As the role of CDMOs in the pharmaceutical landscape continue to grow and evolve, the path to excellence remains clear. Quality is the foundation that enables speed and flexibility, not the tradeoff against them. Our commitment to quality and our dedication to completing projects reliably on time and in full are driven by the same purpose: the patients we serve. By investing in robust capabilities, controlled processes, and a culture rooted in trust, CDMOs can meet today’s expectations while building long-term confidence with sponsors and patients alike.
To hear more on this topic, watch J.D.’s full interview on the Making it in Manufacturing podcast here
J.D. Mowery has served as the president of Bora’s CDMO business since 2024. He 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.