Logistical challenges demand close collaboration from the early stages of the development process.
Some fundamental requirements apply to all clinical trial supply chains. Manufacturing facilities must comply with Good Manufacturing Practice (GMP) guidelines, including effective sterilization and cold chain management. Formulations must be screened regularly for quality, and containers must be checked for integrity.
At the same time, there’s no one-size-fits-all solution to clinical trial supplies. Throughout Phase I and Phase II trials, an unexpected formulation issue or regulatory development can demand rapid adjustments. The manufacturer’s pipeline needs to be flexible enough to support those adjustments, while incurring minimal costs and delays in the process.
The following article explores some of the most significant factors in successful clinical trial material manufacturing, and recommends steps developers should take to ensure consistency and flexibility throughout the trial period.
Logistical organization can make or break a clinical trial supply chain.
Clinical trials often involve coordination of supply chains across multiple sites, sometimes in different countries. Kit components may originate in several different locations, arrive at a manufacturing facility where they’re assembled into their final configuration, then travel to each trial location in response to demand. Throughout all these steps, the product must be stored at a correct temperature, and protected against contaminants, breakage, and other harm.
Shipments must be monitored at every stop to check for environmental variations and other potential quality risks. Since direct delivery to patients is often infeasible within regulatory guidelines, the product must be distributed from multiple storage depots, which means inventory levels must be carefully managed and coordinated across depot sites. Deliveries must be made according to precise schedules. Patient adherence must also be monitored and controlled, to ensure the validity of data collected during the trial.
For all these reasons, many pharmaceutical developers and contract manufacturing organizations (CMOs) now partner with logistics firms, who offer significant expertise in streamlining supply chains, maintaining ideal storage environments, and optimizing inventory levels. By partnering with these supply chain experts, developers are able to use the clinical trial stage not only to fine-tune the viability of the formulation itself, but also to prepare their distribution pipelines for an eventual commercial-scale drug release.
Collaborative planning should begin well before the start of the first trial.
Product development often begins as soon as a viable active pharmaceutical ingredient (API) is discovered. Once timelines are set, the pressure is on to optimize the formulation’s solubility and delivery mechanism, and address any environmental requirements. Problems in any of these areas can compromise the entire supply chain once a clinical trial is up and running, which means it’s critical to begin collaborating with an experienced CMO early in the development process.
By working closely with a clinical trial material manufacturer throughout the drug development pipeline, pharma developers tap into a ready source of expertise on packaging, cold chain management, and other logistical issues that may impact the design of the drug itself. Along the way, the CMO can help optimize the developer’s supply strategy, planning for consistent delivery of raw materials and kit components as production ramps up for clinical trials.
Contract manufacturers bring not only experience to the table, but also use a range of digital tools to monitor supply chains, forecast material requirements, and make concrete recommendations on ideal supply levels and cost ceilings. In all these ways, experienced CMOs can help developers plan well in advance of project deadlines, and anticipate and respond to a variety of factors that might otherwise be difficult to foresee.
A full-service CMO can provide a holistic perspective, helping to maximize efficiency.
Choosing the right outsourcing partners can be a challenge. In order to effectively mitigate risk and manage the manufacturing process as a whole, clear communication and close collaboration are essential. While some CMOs freely share their latest insights about project requirements, others operate more like “black boxes,” adhering to their own internal processes, and focusing more on delivery speed than on meaningful collaboration. A lack of openness on either side of the partnership can result in missed deadlines, lost product, or even an invalidated clinical trial.
When choosing a manufacturing partner, look for one that works with a large network of suppliers and logistics firms. Such a network not only serves as a testament to the organization’s collaborationassi skills; it also gives the CMO them a high-level overview of the entire manufacturing and distribution pipeline. This holistic view enables end-to-end manufacturing organizations to develop a clear framework encompassing every aspect of a clinical trial, from manufacturing issues to regulatory hurdles and shifting market trends.
The security provided by this high-level overview can enable developers to direct their attention where it’s needed most: on the optimization of the drug itself. While the CMO handles supply chains, distribution networks, inventory levels and regulatory challenges, the developer can focus on analyzing trial data, making adjustments to the formulation, and even moving forward with new drug discovery processes.
Although a clinical trial involved significant logistical challenges, a policy of tight collaboration with a material manfacturing partner can circumvent many common problems. By foreseeing and preventing interruptions in material delivery, providing ideal environments for drug storage, and ensuring optimal stock levels at all distribution points, experienced CMOs help prevent costly disruptions and time-consuming delays. Finding and vetting the right manufacturing partner does take time; but a good fit will offer returns on investment throughout the clinical trial period, and well into the commercial manufacturing stage.