Revised on June 8, 2021
As the clinical supply industry evolves, so does its vernacular. Small molecules are making way for large ones, resulting in “genetic therapies.” We no longer work in ambient conditions; today, “controlled room temperature” best describes the handling process. Even the term “sponsor company” evolved from the fact that companies other than R&D pharmaceuticals are running trials.
One drawback to this evolution is language’s habit of lingering beyond its logical lifespan. If you still “dial” someone’s number but haven’t touched a rotary phone in decades, or “roll up” the automatic windows in your car, you understand the habit of holding onto sayings even after they stop making literal sense. In the clinical packaging industry, a memorable example is IVRS, short for Interactive Voice Response Systems. When IVRS began giving way to voiceless Interactive Response Technology (IRT) in the late 1990s, “IVRS” hung on, serving as the default terminology for years after voice features had faded.
Today, the term “CMO” is the primary offender on the nomenclature front. If the exact definition of CMO leaves you scratching your head, it’s proof positive of the problem. Today, we still — astonishingly — use “contract manufacturing organization” to describe the drug substance manufacturer, the drug product manufacturer, the fill/finish vendor, and the clinical packaging group that does not technically “manufacture” a single thing.
The misnomer traces back a few decades to when pharmaceutical companies handled packaging, labeling, and distribution in-house. Executed in close proximity to manufacturing and production (by companies best known for manufacturing and production), packaging, labeling, and distribution were lumped under the “manufacturing” umbrella. In time, pharmaceutical companies restructured and began outsourcing manufacturing, packaging, labeling, and distribution to vendors designed specifically for those highly regulated services. Erroneously, the “CMO” categorization went along with all these activities.
This ambiguity strikes at the very heart of how different stages of drug development are managed when outsourced. CMC professionals — the acronym standing, of course, for Chemistry, Manufacturing, and Controls — select, qualify, and oversee vendors that manage the drug substance manufacturers, the drug product manufacturers, and the fill/finish stages of drug development. But it is the clinical supply managers who select and actually work with the clinical packaging vendors. For this reason, a new term has emerged for providers specializing in packaging, labeling, and distribution: contract packaging organizations (CPOs). This naming breakout is in step with the clinical supply industry’s commitment to advancing drug innovation within a field that can’t afford confusion.
Xerimis is a CPO with global experience. By identifying as a CPO rather than a CMO, we distinguish ourselves from companies that don’t offer our caliber of expertise and specialization in clinical trial packaging, labeling, distribution, and related services. Contact us to learn more.