Clinical trials are an integral part of the drug development process, but successful clinical trials require materials that can be quickly and reliably produced in accordance with the dynamic demands of trial protocols.
The manufacture of clinical trial material (CTM) often happens at smaller scale than other contract manufacturing operations, and may come with highly specific restrictions and limitations. Clinics rely on CMOs that have the capacity and expertise to produce CTM quickly and consistently, under the rigorous conditions within which clinical trials must be performed.
Delays in obtaining CTM can lead to unacceptable gaps in the budget and project timeline of the entire trial, which can add expense and delay to getting drug product onto the market. Hence, project managers need CMOs that can produce CTM on time and on demand, whatever the parameters of the trial protocol.
Clinics rely on cGMP CMOs that can handle every aspect of clinical trial material manufacturing—from raw materials to final drug product.
The quickest and surest path to successful clinical trial material manufacturing is a CMO that has the capacity and the expertise to handle everything in-house—from assembling raw materials to labeling the final drug product (FDP) for distribution to the clinic.
There are many reasons for this, but perhaps the simplest is that having all the steps of clinical trial material manufacturing handled under one roof limits the number of GMP audits that need to be performed. If the CMO outsources formulation or labeling to other companies, those companies must also be audited for compliance, adding to the time and expense of the project.
Ultimately, this is only one of the ways that a start-to-finish CMO helps expedite the manufacture of CTM. Results for in-process testing are also much faster when it can be performed in-house. Obtaining results from an outside lab can take up to 24 hours, while those results can be achieved same-day when testing in-house.
In addition, the formulation process for the CTM itself may benefit from a CMO that can handle every aspect of the manufacturing process. Many clinical trial materials have time and temperature constraints that may be difficult or costly to adhere to if raw materials or formulated products have to be moved from one location to another.
Even when CMOs have the capacity for clinical trial material manufacturing, they may lack the necessary expertise.
Clinical trial material manufacturing requires more than simply enough laboratory space, machines, or loading and storage capacity to reliably produce the CTM necessary for a project. A specialized labor force is necessary to manufacture CTM according to cGMP guidelines.
Whether that means pipetting, testing, labeling, or simply handling the final drug product, this specialized training is often the difference between a successful project and a potential disaster. However, CMOs that operate at limited capacity also have a necessarily smaller crew, which may mean that they lack the expertise and experience necessary to manufacture CTM products efficiently.
If a CMO does not routinely perform this type of manufacturing, they may not have an adequate laboratory staff on hand, for example. While their pharmaceutical testing team may be able to do the job correctly, if they don’t have a lot of practice with CTM it may take longer than is necessary to perform the same tests to cGMP standards. A full-service CMO, on the other hand, will have a team that is ready and well-versed in CTM manufacturing.
The best CMOs for clinical trial material manufacturing can not only manufacture and label, but also test the final drug product on-site.
When clinical trial material arrives at the clinic, it should be ready to go. That means it has been produced according to cGMP guidelines, tested, and properly packaged and labeled. The quickest and safest way to ensure all of this is to do it all under one roof.
From the QC inspections of the raw materials and container systems to in-process testing during formulation to fill/finish and FDP testing, issuing a CoA, and release of the product to the clinic—when one CMO can handle the entire manufacturing process, there’s less opportunity for something to go wrong.
Clinical trials are cost-intensive, both in terms of money and time. It costs an estimated $1.7 billion to bring a new drug to market, and takes an average of 12 years to move from the earliest stages to final approval. Even then, only about 1 in every 5,000 new products make it all the way through preclinical and clinical trials to finally reach consumers.
With all that in mind, it’s no wonder that those who are embarking on clinical trials need to eliminate every possible point of delay or failure that they can—starting by ensuring that they’re working with a CMO that can perform as much of the clinical trial material manufacturing process as possible.