Contract development and manufacturing organizations (CDMOs) are companies that offer a wide range of services related to drug development and manufacturing. CDMOs do everything from R&D to clinical manufacturing and commercial production.
Pharma companies partner with CDMOs to accelerate innovation by outsourcing some (or all) of their development and manufacturing needs. It’s a mutually beneficial relationship that saves pharma companies valuable time while also reducing infrastructure costs such as those associated with equipment, facilities, and labor.
Most importantly, pharma companies can remain agile and respond quickly to changing market conditions — which is crucial to maintaining a healthy bottom line and competitive advantage.
“CDMOs are a crucial piece in the pharmaceutical industry that helps bring treatments to patients faster. They provide manufacturing capacity and development expertise to early startups with innovative drugs. They also help free up manufacturing capital in large pharmaceutical companies so they can invest in new pipelines.”
— Joyce Lifland, Senior Sales Executive, Apprentice
CDMO vs CMO: What’s the difference?
Although you may hear people use CDMO and contract manufacturing organization (CMO) interchangeably, these organizations serve different purposes.
A CDMO is an organization that provides everything needed to successfully develop and manufacture new and existing products, from start to finish. Think of it as a full-service solution that can meet you wherever you are in the drug innovation or production lifecycle.
In contrast, a CMO focuses solely on the manufacturing aspect of drug production. Pharma companies tend to leverage CMOs to save on equipment costs associated with mass production, especially during the earlier phases when approval isn’t a guarantee.
Why are CDMOs necessary?
To understand why CDMOs are necessary, it’s important to start with the brass tacks: drug manufacturing is a time-consuming, costly, arduous process. Only one in every 5,000 drugs screened will eventually make it to market. And this process takes about 12 years on average and can cost billions.
The bottom line? If you work in pharmaceutical manufacturing, the odds aren’t in your favor.
However, CDMOs act as a safeguard. These organizations eat a lot of the typical risks associated with drug production because they have ready-to-go facilities, are staffed with seasoned experts, and can provide a level of agility and responsiveness that pharma companies need to navigate changing market conditions.
Common challenges to working with CDMOs
There are a number of issues that organizations may face when partnering with CDMOs.
These challenges include:
- Data delays and visibility issues
- Restrictions on imports and exports
- Communication across multiple platforms
- Supply demand versus availability
Left unaddressed, these challenges may create a ripple effect in the drug production lifecycle, resulting in costly delays and resource waste.
“The two main challenges can be summarized as supplies and speed. Demand for critical supplies remains high from manufacturing, healthcare, and other essential businesses and nations continue to ramp up stockpiling measures.
“For CDMOs, the pandemic levels of activity continue. Disruption sets a new bar and becomes the norm. At the same time, we have to move at extraordinary speed and the needs change quickly, demanding extreme agility.”
— Anish Parikh, VP of Sales and Marketing, Drug Products, Curia Global, Inc.
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