In the modern pharmaceutical industry, Contract Development and Manufacturing Organisations (CDMOs) have become integral players. However, this was not always the case. Before the CDMO surge in the 1990s, these organisations were relatively rare. Emerging initially in the 1980s as an industrial solution to address capacity challenges, the CDMO sector is now conservatively expected to surpass $340 billion by 2033. This rapid growth has naturally driven advancements in service offerings, such as expertise in handling complex and highly potent dosage forms, scalability from early clinical stages to full commercial launch, and continuous investment in cutting-edge technologies and state-of the-art facilities.

While there are now over 500 CDMOs operating globally, only a small fraction of these organisations are equipped to act as long-term strategic partners for their clients. A truly strategic CDMO goes beyond the role of a basic service provider. It serves as a consultative partner, offering a range of non-core, value-added services in addition to the core functions of development, manufacturing, and packaging. By doing so, it becomes an extension of its sponsor organisation, embedding itself deeply into the supply chain and enabling greater collaboration and efficiency.

With data indicating that approximately 41% of drug compounds are classified as highly potent – requiring an Occupational Exposure Limit (OEL) of 10 µg/m³ or lower – the ability to develop and manufacture such challenging dosage forms has become a highly sought-after capability in the CDMO space. This article delves into a real-world case study, demonstrating how a CDMO leveraged its global network and decades of expertise to successfully tech transfer, develop, and manufacture a highly potent solid oral drug product, ensuring a seamless transition from clinical supply to commercial launch.

Drug Product Overview

The drug product at the centre of this case study is a selective sphingosine 1-phosphate (S1P) receptor modulator, approved for the treatment of moderately to severely active ulcerative colitis (UC).

At the time of initial tech transfer, the Active Pharmaceutical Ingredient (API) was classified with an Occupational Exposure Limit (OEL) of 0.1 µg/m3. As is often the case in the development of highly potent drug products, additional data emerged over time, enabling the CDMO to re-evaluate the potency classification. Following this assessment, the API was reassigned an OEL of 0.2 µg/m3 – a slight adjustment that, while notable, remained well within the high-potency category. This classification necessitated the use of engineered containment measures throughout all stages of development and manufacturing to uphold both operator safety and product integrity.