Selkirk Pharma launches ClinFAST to accelerate clinical trial manufacturing

Selkirk Pharma, Inc., a privately held pharmaceutical manufacturer based in Spokane, Washington, has introduced ClinFAST, a new service designed to eliminate one of the most critical bottlenecks in clinical drug development—delays in the fill/finish process for injectable drug products. This strategic initiative aims to streamline production timelines for clinical trial materials, providing biotech and pharmaceutical companies with a faster, more reliable path to market without compromising quality or regulatory compliance.

As the demand for speed and efficiency in drug development grows, especially in the wake of global health challenges, ClinFAST positions Selkirk Pharma at the forefront of pharmaceutical manufacturing innovation.

Why Is Fill/Finish a Major Bottleneck in Clinical Trials?

The fill/finish process—the stage where sterile drug substances are transferred into final containers, sealed, and prepared for distribution—is often a major hurdle in clinical trials. This step, although technically straightforward, is critical because it ensures the sterility and safety of injectable drugs, including vaccines and biologics.

For many biotech firms, securing fill/finish capacity can be challenging. Large contract manufacturing organisations (CMOs) typically prioritise high-volume commercial projects, leaving small-batch clinical trial materials at the back of the queue. This often leads to delays ranging from six to twelve months, significantly affecting clinical trial timelines and increasing development costs.

Selkirk Pharma’s ClinFAST is specifically designed to address this gap, offering rapid turnaround times for clinical trial materials without sacrificing the stringent quality standards required in the pharmaceutical industry.

What Makes ClinFAST a Game-Changer for Biotech and Pharma Companies?

ClinFAST isn’t just another fill/finish service—it’s a paradigm shift in how clinical trial materials are produced. Unlike traditional CMOs that operate on rigid schedules and prioritise large commercial batches, ClinFAST adopts a flexible, risk-based approach tailored for small-volume clinical projects.

According to Colleen Dixon, CEO of Selkirk Pharma, ClinFAST is built on three core principles: speed, reliability, and quality. Dixon emphasised that delays in sterile fill/finish can result in missed clinical milestones and financial setbacks. ClinFAST mitigates these risks by offering biotech and pharmaceutical companies immediate access to high-quality drug product manufacturing, helping them stay on track with their clinical development programmes.

The service leverages Selkirk’s state-of-the-art equipment, experienced workforce, and on-site inventory of critical materials—including ISO-sized vials, stoppers, and excipients—to reduce lead times. Moreover, the ability to incorporate customer-supplied materials provides an added layer of flexibility, making ClinFAST adaptable to diverse clinical trial needs.

How Does ClinFAST Improve Clinical Trial Timelines?

One of the most significant advantages of ClinFAST is its ability to accelerate clinical trial timelines. Traditional fill/finish processes often involve long wait times due to scheduling backlogs and supply chain constraints. ClinFAST eliminates these inefficiencies through parallel processing and a templated approach that optimises every stage of production, from compounding to final product release.

By maintaining an on-site inventory of critical components, Selkirk Pharma reduces the time typically spent sourcing materials from external suppliers. This not only expedites production but also minimises the risk of supply chain disruptions—a factor that has become increasingly important in the post-pandemic pharmaceutical landscape.

Furthermore, Selkirk’s advanced fill/finish technologies are designed to maximise yield and minimise product loss, ensuring consistent quality across batches. This high-yield processing capability is particularly beneficial for clinical trial materials, where every vial counts.

Can ClinFAST Scale Beyond Clinical Trials?

While ClinFAST is primarily designed to support Phase 1 and Phase 2 clinical trials, its scalability makes it suitable for commercial manufacturing as well. This seamless transition from clinical to commercial production is a key differentiator, allowing biotech and pharmaceutical companies to maintain continuity as they progress through the drug development lifecycle.

Selkirk Pharma’s manufacturing infrastructure is built with scalability in mind. The company’s facilities are equipped to handle batch sizes of up to 10,000 vials, with the flexibility to support both small clinical projects and larger commercial campaigns. This means that companies partnering with Selkirk through ClinFAST can avoid the disruption of transferring their manufacturing processes to new facilities when moving from clinical trials to market launch.

How Does Selkirk Pharma Ensure Quality Without Compromising Speed?

Speed without quality is a recipe for failure in pharmaceutical manufacturing. Selkirk Pharma recognises this and has integrated robust quality control measures into every stage of the ClinFAST process. The company’s risk-based approach ensures that efficiency does not come at the expense of compliance or patient safety.

Selkirk’s team of industry veterans, averaging over 15 years of experience, plays a pivotal role in maintaining these high standards. The company’s culture of continuous improvement, combined with advanced technologies and stringent regulatory oversight, ensures that every batch of clinical trial material meets the highest quality benchmarks.

Additionally, Selkirk Pharma’s commitment to partnership-driven manufacturing fosters close collaboration with clients. This ensures that project-specific requirements are met, timelines are adhered to, and potential risks are identified and mitigated early in the process.

The Future of Clinical Trial Manufacturing with ClinFAST

As the pharmaceutical industry continues to evolve, the need for flexible, efficient, and high-quality manufacturing solutions becomes increasingly critical. Selkirk Pharma’s ClinFAST service represents a bold step forward, addressing a longstanding challenge in clinical drug development: the bottleneck of sterile fill/finish capacity.

By combining speed, scalability, and uncompromising quality, ClinFAST is set to become an indispensable resource for biotech and pharmaceutical companies worldwide. Whether accelerating early-phase clinical trials or supporting large-scale commercial launches, Selkirk Pharma’s innovative approach to drug product manufacturing is reshaping the future of clinical development.