European Pharmaceutical Manufacturer asks John McDermott, vice president of scientific consulting at Quotient Sciences what the benefits are of using a CRDMO?
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What are the benefits of using a CRDMO?
CRDMOs offer a number of strategic and operational benefits for pharmaceutical and biotech companies, with the exact benefits dependent upon the nature of the particular CRDMO.
CRDMOs combine the capabilities of CROs (Contract Research Organisations) and CDMOs (Contract Development and Manufacturing Organisations), into a single partner. This integration provides the potential to seamlessly translate development activities between discovery, development, and manufacturing.
By consolidating services under one roof, CRDMOs eliminate the need for multiple handoffs between vendors. This can significantly shorten development timelines, especially for early-phase programs and avoids miscommunication between separate partners.
Importantly, CRDMOs have multidisciplinary teams who can provide deep scientific and regulatory expertise in traditionally separate fields including biopharmaceutics, formulation science, regulatory affairs and clinical trial design, execution and interpretation. This helps sponsors navigate complex regulatory pathways more effectively.
What advantages does integration offer to drug development?
Integration in drug development—especially through platforms like CRDMOs or unified development models— is central to achieving success. The productivity of our industry during the pandemic showed what can be achieved when we truly work together. Major advantages can be achieved including enhancements in efficiency, quality, and reduction of development costs.
At Quotient Sciences we pioneered the benefits of integration as a CRDMO over 15 years ago when we launched our Translational Pharmaceutics® platform. Translational Pharmaceutics is a disruptive approach to drug development that integrates formulation development, manufacturing, and clinical testing into a single, seamless process. Unlike the traditional, separate CDMO and CRO model that operates in silos, this horizontally integrated platform eliminates “white space”, streamlining the supply chain and reducing oversight complexity. This integration enables adaptive drug product and clinical strategies, resulting in significant efficiencies in both active pharmaceutical ingredient (API) usage and drug product development.
One of the most impactful benefits is the acceleration of development timelines—often saving over 12 months compared to conventional approaches. This is achieved by manufacturing drug products in real time during clinical studies, which reduces the need for extensive stability data and allows for smaller batch sizes. The platform supports rapid “make-test” cycles, where emerging clinical data directly informs the next formulation to be manufactured and dosed. This iterative process not only enhances formulation optimisation but also reduces the risk of late-stage clinical failure due to suboptimal drug performance.
By integrating formulation, analytical development, on-demand manufacturing, clinical testing, and real-time bioanalysis, Translational Pharmaceutics delivers a more agile, efficient, and data-driven pathway from lab to clinic—ultimately accelerating the journey of new medicines to patients.
How and when is Translational Pharmaceutics applied by development teams?
Translational Pharmaceutics has two principal applications in early-phase drug development. The first is in support of the first-in-human (FIH) trial, where typically flexible, but very simple drug products are applied. These drug products are rarely viable for chronic administration, so it is beneficial to avoid investment in drug product manufactured at scale at a traditional CDMO, when that material will not be needed after Phase I is complete. An agile ‘on-demand’ supply chain allows the development team to only make the exact product needed for dosing, minimise drug product investment and avoid lengthy stability studies needed to support a non-integrated supply chain.
Another key application is in Rapid Formulation Development and Clinical Testing, where the platform enables real-time screening and optimisation of drug product composition. These compositions can be evaluated in crossover clinical studies where rapid “make-test” cycles allow researchers to adapt formulations based on emerging clinical data. This is particularly beneficial for challenging molecules, such as poorly soluble drugs, or in modified release development where formulation design spaces can be used to fine tune the composition and achieving the correct release rate and overall exposure profile.