What started in the 1980s as an industrial stopgap to fulfil capacity needs is now conservatively projected to become a $340+ billion market in 2033, reports David O’Connell, Director of Scientific Affairs at PCI Pharma Services.1
Naturally, when an industry grows so quickly, so does the evolution of service offerings — such as the ability to handle complex and highly potent dosage forms, scalability from early clinical supply to commercial launch and the continued investment in, and expansion of, industry leading technology and facilities.
Whereas reports estimate that more than 500 CDMOs are currently operating around the globe, only a small percentage are able to act as a long-term strategic partner to their clients.2
A strategic CDMO is more than just a service provider: it serves in a consultative capacity; it provides a range of non-core value-added functions alongside the central roles of development, manufacture and packaging; and, in doing so, becomes an extension of the sponsor organisation rather than just another supply chain vendor.
With data suggesting that approximately 41% of drug compounds are considered to be highly potent, registering an occupational exposure limit (OEL) of 10 µg/m3 or less, the ability to develop and manufacture such dosage forms is becoming an increasingly desirable skill in the CDMO space.3
This article explores a real-world case study regarding how a CDMO successfully onboarded, developed and manufactured a highly potent solid oral drug product, utilising its global network and decades of experience to ensure a smooth journey from clinical supply to commercial launch.
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