Selkirk Pharma
Selkirk Pharma is a leading US-based contract manufacturing organization specializing in sterile fill/finish of injectable drug products. Founded in 2018 by industry experts, the company is committed to delivering high-quality products on time and in full, with a focus on innovation, reliability, and regulatory compliance. With state-of-the-art facilities in Spokane, Washington, and a highly experienced team, Selkirk Pharma offers scalable solutions for clinical trial materials and commercial manufacturing, including rapid fill/finish services through its proprietary ClinFAST™ program. The company's mission is to ensure that injectable drugs reach patients efficiently and safely, leveraging advanced technology and a culture of continuous improvement.
Industries
Nr. of Employees
medium (51-250)
Selkirk Pharma
Spokane, Washington, United States, North America
Products
Aseptic Fill/Finish Services
Selkirk Pharma provides aseptic fill and finish services for injectable drugs, including vaccines and biological therapeutics, utilizing advanced technology for high quality and yield.
Advanced Manufacturing Facility
The company operates a purpose-built aseptic manufacturing facility equipped with unidirectional flow technology, single-use systems, SKAN isolator technology, and Bausch and Strobel VarioSys filling systems.
Bausch + Strobel VarioSys Fill Line
Features a Bausch and Strobel VarioSys filler with integrated vial rinser and depyrogenation tunnel, designed for efficient and high-yield drug product manufacturing.
Aseptic Fill/Finish Services
Selkirk Pharma provides aseptic fill and finish services for injectable drugs, including vaccines and biological therapeutics, utilizing advanced technology for high quality and yield.
Advanced Manufacturing Facility
The company operates a purpose-built aseptic manufacturing facility equipped with unidirectional flow technology, single-use systems, SKAN isolator technology, and Bausch and Strobel VarioSys filling systems.
Bausch + Strobel VarioSys Fill Line
Features a Bausch and Strobel VarioSys filler with integrated vial rinser and depyrogenation tunnel, designed for efficient and high-yield drug product manufacturing.
Services
Sterile Fill/Finish Manufacturing (vials)
End-to-end aseptic vial filling, stoppering, sealing, and release for clinical and commercial projects, including compounding, in-process controls, and batch record review.
Rapid clinical trial material manufacturing (small-volume)
Accelerated small-volume clinical fill/finish service for Phase 1–2 supplies using templated processes, parallel runs, and maintained component inventory to shorten lead times.
Analytical and Microbiological Testing (in-house QC)
Comprehensive AQC and MQC services including chromatography, spectroscopy, particulate analysis, endotoxin, bioburden, sterility, and microbial identification to support release and troubleshooting.
Finished Product Inspection
100% manual visual inspection per USP 790, AQL sampling, procedures for difficult-to-inspect products, and in-house defect kit production for inspector qualification.
Supply Chain and Cold-Chain Support
Inventory management, vendor coordination, dual sourcing, and temperature-controlled storage and distribution to support fill/finish timelines and product integrity.
Regulatory Affairs and CMC Support
Regulatory operations and intelligence supporting CMC, manufacturing site transfers, global submissions, and lifecycle regulatory strategy.
Sterile Fill/Finish Manufacturing (vials)
End-to-end aseptic vial filling, stoppering, sealing, and release for clinical and commercial projects, including compounding, in-process controls, and batch record review.
Rapid clinical trial material manufacturing (small-volume)
Accelerated small-volume clinical fill/finish service for Phase 1–2 supplies using templated processes, parallel runs, and maintained component inventory to shorten lead times.
Analytical and Microbiological Testing (in-house QC)
Comprehensive AQC and MQC services including chromatography, spectroscopy, particulate analysis, endotoxin, bioburden, sterility, and microbial identification to support release and troubleshooting.
Finished Product Inspection
100% manual visual inspection per USP 790, AQL sampling, procedures for difficult-to-inspect products, and in-house defect kit production for inspector qualification.
Supply Chain and Cold-Chain Support
Inventory management, vendor coordination, dual sourcing, and temperature-controlled storage and distribution to support fill/finish timelines and product integrity.
Regulatory Affairs and CMC Support
Regulatory operations and intelligence supporting CMC, manufacturing site transfers, global submissions, and lifecycle regulatory strategy.
Expertise Areas
- Sterile fill/finish manufacturing for vials
- Clinical trial supply manufacturing (Phase 1–3)
- Analytical and microbiological testing and method transfer
- Regulatory CMC support and global compliance (FDA, EU Annex 1)
Key Technologies
- Isolator aseptic filling systems
- High-yield automated vial filling lines with depyrogenation tunnel
- Vaporized hydrogen peroxide (VHP) sterilization
- Single-use systems (SUS)