CMO Clinical Trials

Introduction: What does CMO stand for in pharma and clinical research?

In the worlds of pharmaceutical development (drug development) and clinical research, the abbreviation CMO refers to a contract manufacturing organization. These organizations are companies that serve the pharmaceutical industry and trial sponsors by providing comprehensive services related to manufacturing. Biotech firms, pharmaceutical companies, and research institutions might outsource the manufacturing of a drug (which could be either an investigational product or an approved drug) to a CMO in order to focus their own limited resources on the aspects of drug development and clinical research they specialize in.

Essentially, CMO (contract manufacturing organizations) allow pharmaceutical companies to outsource the manufacturing part of the drug development chain, helping them bring new drugs and treatments to market faster and at a lower cost.

A CMO is closely related to CDMO, which we will explore in the next section, and also to contract research organizations (CRO), which typically offer more comprehensive services related to conducting clinical trials.

CRO vs CMO: What is the difference between a CRO and a CMO?

Both contract research organizations (CROs) and contract manufacturing organizations (CMOs) are contracted to undertake significant tasks involved in the drug development and clinical research processes, but they largely specialize in different services.

A CRO primarily focuses on conducting clinical trials (either in part or in whole), offering services such as trial design, project management, site selection, patient recruitment, data management, statistical analysis, and support, among others. Most CROs can essentially handle all aspects relating to the regulatory testing that needs to be done on new drugs (i.e., clinical trials) before they can be approved for human use.

On other hand, a CMO is primarily involved with manufacturing activities – they produce the actual drug product, under strict quality control measures to ensure consistency and purity of the drug – whether that be an investigational product (study drug) or an approved drug that is being investigated in other ways, for example in post-marketing surveillance studies (phase IV trials). The role of a CMO is important because study drugs must meet stringent standards in order to be used in research, and trial sponsors can outsource the manufacturing process to professional chemists (the CMO). A CMO might synthesize the drug molecule or prepare it into certain formulations (like tablets, injectable solutions, etc.) – or both.

To summarize the CRO vs CMO distinction, both can be contracted by pharma and biotech companies and other trial sponsors, but CROs offer comprehensive clinical research services whereas CMOs specialize in drug manufacturing.

In addition to these terms, there is also a type of company known as a CDMO, or contract development and manufacturing organization. A CDMO is similar to a CMO, but as the name implies, they can also get involved in the drug development aspect. CDMOs are described in further detail below.

Outsourcing manufacturing: What is the difference between a CMO and a CDMO?

A contract development and manufacturing organization (CDMO) generally provides more comprehensive services compared to a contract manufacturing organization (CMO). In addition to large-scale drug production capabilities, like a CMO would have, CDMOs may offer integrated services beginning from the early stages of drug development, including refining the formulation, stability studies, analytical validation, and maybe even preclinical (laboratory) studies on the drug.[1]

Today, the terms CMO and CDMO are sometimes used interchangeably, particularly amidst the industry wide trend of consolidating services into “one-stop-shop” providers, which has also blurred the lines between CMOs and CDMOs (and even CROs, who may get involved in drug discovery or development). CDMOs technically developed as an evolution of CMOs, adding additional aspects of drug development (or even drug discovery) to the manufacturing services.[2] Since a CDMO offers more comprehensive services, they are usually better suited for outsourcing aspects of preclinical and early-phase trials, during which time the drug formulation may still be adjusted. Once dosage, route of administration, and other details have been confirmed, a sponsor may look to a CMO who may be better equipped for scaling-up production, i.e., manufacturing larger quantities of the final formulation, to prepare for phase III trials.[1]

What role does a contract manufacturing organization (CMO) play in clinical trials?

Many newer pharmaceutical companies and trial sponsors do not have strong CMC skills or capabilities (“chemistry manufacturing and controls”), and thus, when they identify a promising drug candidate and want to test it in preclinical studies or clinical trials, CMOs or CDMOs bring this skill to the table.[1] Facilities producing pharmaceutical drugs for human use must meet strict regulations, primarily cGMP (current good manufacturing practices), which ensures the end product is sterile, pure, and consistent between batches. Since the actual production (and/or formulation) of the drugs is not usually one of the main foci of trial sponsors’ operations, it is both handy and resource-efficient to outsource manufacturing to a CMO or CDMO.

In case you’d like further clarification, you can think of it like this - imagine you are the director of a grand-scale theater production. As the director, you already have a whole set of tasks to focus on, which likely occupy your entire schedule. You’d want to be able to select scenes and props, but not have to sew costumes and do construction after a full day’s work. Similarly, as lots of work goes into identifying potential drug candidates, pharma companies will want to proceed to preclinical studies as quickly as possible, without having to equip an entire chemistry lab in their headquarters, hire a team of chemists, and train staff on cGMP. Of course, if a sponsor is conducting many trials over time and wishes to continue expanding, there is always the option of establishing this capability in-house, which could end up saving time and money at the end of the day. The same logic applies to contracting CROs to conduct clinical trials, which are complex and multi-faceted undertakings which, in some cases, may be conducted much more efficiently by outsourcing them to professionals with strong expertise.

Conclusion

By outsourcing manufacturing to a CMO, clinical trials sponsors can focus their resources on their core operations, and move more quickly and more efficiently through the clinical research process – an undertaking that already requires significant time and resources, and which can be streamlined by optimizing the allocation of limited resources.