Selkirk Pharma, a U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, has launched ClinFAST, a service designed to assist clinical stage biotech and pharma companies with a rapid fill/finish process for clinical trial supplies. By reducing production timelines while maintaining high-quality standards, ClinFAST addresses a challenge faced by drug developers—securing fill/finish capacity in a market where small-batch projects are often deprioritized by larger contract manufacturing organizations (CMOs).

“In clinical drug development, time is everything. Delays in sterile fill/finish can mean missed trial milestones and significant financial setbacks,” said Colleen Dixon, CEO of Selkirk Pharma. “ClinFAST represents a significant advancement in our ability to ensure biotech and pharma companies can access the high-quality drug product manufacturing they need—without the typical wait times. Our experienced team, best-in-class equipment, and commitment to excellence mean our clients can trust us to help them stay on track and bring life-saving treatments to patients faster.”

A faster path to clinical trials without sacrificing quality

The traditional fill/finish landscape presents major hurdles for small-volume projects, with waiting periods ranging from 6 to 12 months for an available slot. ClinFAST eliminates these delays by running production processes in parallel and leveraging a templated approach that streamlines each step—from compounding to final release. Selkirk Pharma maintains an on-site inventory of ISO-sized vials, stoppers, filling assemblies, and excipients, reducing the lead time required for sourcing materials. The company also offers flexibility for clients to incorporate customer-supplied materials that align with the ClinFAST process.

Key advantages of ClinFAST:

• Rapid turnaround: Delivers clinical trial materials in a fraction of the time required by larger CMOs.

• Batch sizes up to 10,000 vials: Ideal for liquid-filled vials used in Phase 1 and 2 trials.

• High-yield processing: State-of-the-art equipment minimizes line-loss and ensures consistent filled-container yields.

• Scalability: Capable of supporting clients beyond clinical trials with commercial-scale manufacturing capacity.