US injectable drug manufacturer, Selkirk Pharma has launched ClinFAST, a clinical-stage fill/finish service.
The offering is designed to support biotech and pharmaceutical companies who are progressing their therapeutics through clinical trials, as larger contract manufacturers (CMOs) often deprioritise smaller projects.
Through this service, Selkirk Pharma aims to reduce production timelines, while still offering a high-quality service.
Waiting periods for small-volume projects can be as long as 12 months, so Selkirk designed ClinFAST to overcome this issue.
Selkirk can achieve fast turnarounds by running production processes in parallel and utilising a 'template' approach to each manufacturing step.
“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.”
To assist its clients, 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.
Currently, the company offers batch sizes of up to 10,000 vials, as well as scalability for clients moving beyond clinical trials.