Introduction
The term CDMO (contract (or sometimes custom) development and manufacturing organisation) has become ubiquitous in the pharmaceutical industry over the past decade. Now the terms CRDMO and CDTMO have emerged, with the R standing for research and the T for testing, respectively. Indeed, Sterling Pharma Solutions has begun calling itself a PDMO, with the P standing for partnership, and trademarked the term for good measure. Certainly, ‘CDMO’ has become a buzzword if not a cliché in the industry and the concept has become very broad. It certainly represents something but is it actually a paradigm change in how drugs are developed and manufactured? Evaluate brought together senior executives from both chemical and biological CDMOs and others in a live roundtable at CPHI in Milan in October to discuss these issues and more.
Buzzword
Paradigm Change
Historically, service providers were generally classified as CROs (contract research organisations) and CMOs (contract manufacturing organisations). Whilst the gulf between them was never absolute, it was understood. Pharma companies would outsource early-stage development to a CRO and later-stage development and manufacturing to a CMO. Over time, more companies tried to create the proverbial ‘one-stop shop’, hoping to take compounds all the way through the phases of development and into manufacture post-launch.Dr. Nigel Stapleton, VP of business development & head of Europe at the biologics CDMO Mabion which specialises in clinical and commercial manufacturing of antibodies, said he understood why the term is so widely used at exhibitions. Companies want to attract the right people to their booth and he sees the term CDMO as “an early attempt to do this and make this acronym really speak for what we're doing”. “We're customer-driven. If a number of clients ask me to take care of something that's not yet in our offering but that neatly fits to it, I'll probably try to develop that. This means that the portfolio of services is growing slowly but surely and to show this off to new potential customers, the acronym might be growing with it,” he said.There is a broad consensus that, rather than develop processes internally and transfer these out, pharmaceutical companies are increasingly bringing in service providers early. This helps them to avoid investment in their plants and take fewer risks in the clinical phases, while focusing on research at the start of drug development and marketing at the end.
