Selkirk Pharma, Inc., a privately held U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, today announced the launch of ClinFAST™, a paradigm-shifting 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 significant 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.
With ClinFAST, Selkirk Pharma provides a dedicated solution to drug developers for meeting critical clinical timelines. The company’s risk-based approach prioritizes
