In the world of drug development, securing timely access to fill/finish services can often pose a critical bottleneck, especially for clinical trials requiring small-volume production. Fill/finish refers to the final steps in the production of injectable pharmaceutical drug substances, including the process of filling vials with a drug substance, sealing them, and ensuring they are sterile and ready for use in clinical settings.

Selkirk Pharma, a leading Annex 1-compliant aseptic fill/finish facility, has recently launched ClinFAST™, a cutting-edge service designed to address the challenges biotech and pharmaceutical companies face when it comes to rapidly obtaining fill/finish services for their clinical trial materials. With ClinFAST, Selkirk Pharma is dramatically shortening timelines while maintaining the high-quality standards required in clinical trials. This innovation is poised to provide an expedited path for getting lifesaving treatments into the hands of patients faster.

To learn more about ClinFAST and the impact it is having on the industry, Drug Discovery News spoke with Selkirk Pharma’s VP of Business Development, Lonnie Barish, who sheds light on how this new service is reshaping the fill/finish landscape for clinical trials.

Why is it particularly important for small-volume projects in early-phase clinical trials to access rapid fill/finish services?

Speed is everything when it comes to clinical trials — especially for maximizing the return on investment (ROI) of a company’s drug. Clinical and Chemistry, Manufacturing, and Controls (CMC) teams must coordinate closely to secure a fill/finish slot immediately after active pharmaceutical ingredient (API) manufacturing; any delay can set back a trial, wasting valuable time, resources, and money. 

The challenge is that open fill/finish slots in the US are hard to come by, particularly for small volumes like in early-phase clinical trials, and companies may find themselves competing with larger, late-phase, or commercial-scale projects for priority at contract manufacturing organizations (CMOs). It’s not uncommon to wait four to eight months for a slot, and in some cases, the delay can stretch  a year. Having a CMO like Selkirk, which is focused on clinical trials, helps these companies produce the needed materials quickly and on time. 

What are the primary bottlenecks that biotech and pharma companies face when looking for fill/finish capacity for small-volume projects?

One of the biggest bottlenecks is simply finding an available fill/finish slot. As mentioned earlier, most CMOs prioritize late-phase or commercial-scale projects, which bring in more revenue, making it harder for small-volume clinical programs to get the attention they need. But even once a slot is secured, the fill/finish process itself can be slow. There are many steps involved, from technology transfer and raw material testing to filling, visual inspection, and final product release.  

Each step involves various internal departments and a significant amount of paperwork, causing the potential for delays at any stage. Selkirk took the time upfront to map out the entire process and determine ways to utilize templated forms, parallel processes, and a multidisciplinary team to streamline the process from start to finish. That’s why we developed ClinFAST, our proprietary platform designed to expedite small-volume fill/finish manufacturing and deliver clinical trial material in a fraction of the time compared to traditional CMOs.

How do fill/finish services maintain high standards of quality control and regulatory compliance, ensuring that expedited timelines do not compromise the integrity of the clinical trial process or fail to meet the industry’s good manufacturing practice (GMP) standards?

At Selkirk Pharma, our facility was purpose-built from the ground up to streamline the fill/finish process — unlike many CMOs that operate out of retrofitted legacy pharma buildings. From day one, we’ve embedded quality into every layer of our operation. Our systems are built on the Pharma 4.0 framework to enable seamless cross-functional communication and process control, and our expert team has designed a robust quality infrastructure grounded in ISO 9001:2015, EU Annex 1, and ICH Q10/Q9 guidelines.

Quality isn’t an afterthought — it’s the core of everything we do. Our ClinFAST process is a testament to this commitment. Designed around our rigorous quality program, ClinFAST uses a proactive risk management approach to accelerate timelines without compromising compliance. By executing activities in parallel and utilizing in-house components, prequalified filtration assemblies and excipients, and standardized workflows, we ensure that clinical trial materials are delivered quickly, consistently, and in full alignment with GMP standards. 

How do rapid fill/finish services address potential risks such as supply chain disruptions, and how can they help ensure continuity in the clinical trial supply process?

To tackle potential supply chain shortages or disruptions, we've designed our program around an in-house supply of components, standardization of fluid pathway assemblies, and released excipients. By keeping these supplies in-house and closely monitoring our inventory, we ensure the seamless implementation of our rapid fill-finish program. This proactive approach allows us to maintain the speed and efficiency needed for clinical trials, no matter what challenges arise. 

What are some of the key technological advancements that have made accelerated fill/finish services more viable for small-volume clinical trials, and how do they improve the overall drug development timeline?

A key part of our ability to provide accelerated fill/finish services for small-volume clinical trials and shorten the overall drug development timeline is our use of the Bausch+Strobel VarioSys filling system. This innovative system boasts a recovery rate of over 99% and minimal line loss, as low as 100 mL. Its 100% in-process control ensures precision and efficiency in every batch. With self-priming and run-empty functionality, it minimizes product loss, with only the last container potentially needing rejection. Combined with fast-turnaround analytical and microbial testing equipment, this technology enhances our rapid fill/finish capabilities, keeping clinical trials on schedule.