De-Risking the Scale-Up Pathway
SPONSORED CONTENT: Pedro Fernandes Botas and Mark Macdonald from Codis break down how advanced spray drying capabilities, mathematical modeling, and commercial operations experience are helping sponsors navigate the modern formulation landscape.
Key Takeaways
Sophisticated Internal Modeling: Utilizing advanced predictive modeling processes to deeply analyze behavior on smaller units and precisely map how those processes will scale to larger, commercial-scale assets on-site.
Early Particle Engineering Expertise: Leveraging extensive technical mastery within spray drying and particle engineering to facilitate critical, risk-mitigating process decisions as early as possible in the molecule lifecycle.
Decades of Commercial Supply: Drawing upon over 20 years of large-scale commercial manufacturing experience to safely, reliably and predictably bring complex compounds to market.
Dynamic Lifecycle Adaptability: Remaining aligned and adaptable to evolving client requirements, clinical timelines, and regulatory goals across all phases of development through to commercial launch.
As contemporary drug pipelines are increasingly defined by complex, poorly soluble, and highly potent molecules, the margin for error in early-stage formulation has all but disappeared. Pharmaceutical sponsors face immense, competing pressures: they must accelerate time-to-market to secure competitive advantages, while simultaneously ensuring long-term manufacturing robustness and supply chain security.
According to Pedro Fernandes Botas, Business Development Director for Europe, and Mark Macdonald, Technical Sales Director at Codis, navigating this environment requires a fundamental shift in perspective. The key to long-term commercial success lies in bridging the historical gap between laboratory R&D and commercial production through a unified, industrially representative mindset from day one.
Spray Drying as a Pivotal Enabling Technology
As molecules under development become structurally more complex, conventional solid-dose formulation approaches frequently reach their physical and chemical limits. In this context, spray drying has emerged as a cornerstone technology across the global pharmaceutical landscape, offering developers an elegant, scalable method to fine-tune critical material characteristics.
By converting liquid feeds into precisely engineered particles, the technology directly optimizes solubility, bioavailability, and long-term physical stability. Furthermore, it enhances downstream flowability and compressibility, which are vital for manufacturing final dosage forms like tablets or capsules.
“What we are seeing today is that more and more molecules are coming to market which are either poorly soluble, highly potent, or structurally complex,” specifies Botas. “In this sense, spray drying is increasingly becoming pivotal as a new product-enabling technology that will allow us to find better products and also to improve existing products in the market for the sake of the patients.”
Beyond basic solubility enhancement, the inherent versatility of the process provides an operational edge. Macdonald points out that organic spray drying stands out because it allows developers to consolidate multiple formulation steps, such as micro-encapsulation and particle sizing, into a single technology platform.
“One of the advantages of spray drying is it can include other enabling technology capabilities,” Macdonald notes. “Spray drying stands out as being available at the small scale to develop and prove the concept of the molecule, and also give clients confidence that the compound could then be scaled up and commercialized in the long term.”
The Peril of Siloed Development
One of the most significant and costly challenges companies face during a product’s lifecycle is the process of tech transfer. When early-stage R&D occurs in absolute isolation from commercial manufacturing realities, a bench-scale success often introduces severe operational vulnerabilities when introduced to automated, high-volume production lines.
“Sponsors are realizing that most of the late-stage risks that they are finding are actually created very early,” Botas asserts. “By engaging with CDMOs sooner, they have additional support in the design of their processes in order to make them scalable, robust, and commercially realistic from the start.”
When clinical manufacturing and long-term commercial supply are kept under a single roof, sponsors drastically reduce the traditional risks of knowledge loss, data fragmentation, and regulatory friction that typically occur when moving a molecule between different facilities.
To bridge this bench-to-commercial gap, Codis relies on advanced digital infrastructure. Macdonald emphasizes that the company leverages sophisticated internal mathematical modeling to de-risk the scale-up pathway before physical material is even introduced to larger systems.
“We've looked to develop internally some quite sophisticated modeling processes,” Macdonald specifies. “We’re able to really understand how the process works on the smaller units and how that will scale to the larger units that we have on site. This is a key factor to try and minimize risk, minimize material usage, and cut timelines on development programs.”
Building a Foundation for Scalability
For Codis, the goal of a partnership is to transform scale-up from a high-risk, disruptive event into a smooth, evolutionary process. Achieving this level of predictability requires a data-driven approach to critical process parameters (CPPs) and critical quality attributes (CQAs) from the very beginning of the project lifecycle.
“We develop the processes with an industrial-representative mindset, which sets the foundation to perform exactly that scale-up,” Botas reveals. “We do this by leveraging our extensive experience in spray drying, and also our process analytics data, which enables us to estimate and predict what will be the key process parameters that we will need to have in the process in order to achieve the desired quality attributes.”
This deep expertise is backed by extensive operational history. CODIS has been running commercial, large-scale spray drying facilities in both the UK and the U.S. for more than two decades, successfully processing thousands of tons of active pharmaceutical ingredients (APIs). With such long-term manufacturing history, the company is able to embed specialized capabilities into its routines and means that the team can offer clients unique insights into process consistency and regulatory compliance.
Looking to the Future of Integrated Strategy
As the industry moves toward an increasingly digitalized era, it is becoming apparent that isolated development strategies are no longer commercially viable. Instead, the integration of science, manufacturing engineering, and supply chain logistics is now a condition for successful commercialization.
“The paradigm is changing in a way that industrial scalability and particularly lifecycle management for these products is becoming a prerequisite, not just a nice-to-have thing,” Botas notes. Looking forward, the focus will intensify on model-based assessments to compress clinical timelines and maximize the utility of scarce or expensive APIs.
"Ultimately, companies will look into developing the leanest and the most cost-effective processes,” Botas summarizes. “And, they will also be considering the long term at earlier points within the development lifecycle not only to differentiate, but also to create line extensions in order to be able to answer the call of the market.”
To learn more about Codis’ integrated capabilities in spray drying and particle engineering, visit Codis.com
Click the video above to view the full interview
About the Speakers
Pedro Fernandes Botas is the new Business Development Director for Europe at Codis, where he will be responsible for identifying new opportunities within Europe and supporting the team as they evolve their commercial approach. Pedro brings a wealth of experience to his new role having previously worked for Lotus Pharmaceutical, Faes Farma, Bene, Labatec Pharma, and Hovione. He has a strong track record of driving commercial performance, building strategic partnerships, and opening new market opportunities across the region.
Mark Macdonald is Technical Sales Director for Codis. Mark is a chartered Chemical Engineer with over 20 years of experience in the pharmaceutical industry across CDMO and Big Pharma enterprises. He has extensive experience in technical roles across the UK, Europe, and the U.S. spanning Engineering, Safety and Project Management and has led Operational teams in a GMP environment. In the commercial space, Mark leverages his years of experience to match client needs with operational capabilities. Mark earned a Master’s degree in Chemical and Process Engineering from the University of Newcastle.
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