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
Products
ClinFAST™
Proprietary rapid fill/finish process to accelerate clinical trial materials for Phase 1, 2, and 3 trials.
Sterile Injectable Fill-Finish Services
Contract manufacturing organization services for sterile fill-finish of injectable drug products, including liquid-filled vials from 0.5mL to 50mL.
Sterile Fill/Finish Manufacturing
State-of-the-art sterile fill/finish manufacturing service utilizing a unidirectional flow design and advanced equipment to ensure high yields and contamination prevention.
Aseptic fill and finish
Comprehensive aseptic fill and finish services utilizing fully integrated isolator filling and advanced dosing systems for high yield filling.
Bausch + Ströbel VarioSys® Fill Line
Fully integrated, high-yield fill line featuring an integrated vial rinser and depyrogenation tunnel with line losses as low as 100mL and filled container yields of >99.8%.
Finished Product Manual Visual Inspection
100% manual visual inspection services complying with USP 790 to ensure packaging integrity and absence of particulate matter, including in-house Defect Kits.
ClinFAST™
Proprietary rapid fill/finish process to accelerate clinical trial materials for Phase 1, 2, and 3 trials.
Sterile Injectable Fill-Finish Services
Contract manufacturing organization services for sterile fill-finish of injectable drug products, including liquid-filled vials from 0.5mL to 50mL.
Sterile Fill/Finish Manufacturing
State-of-the-art sterile fill/finish manufacturing service utilizing a unidirectional flow design and advanced equipment to ensure high yields and contamination prevention.
Aseptic fill and finish
Comprehensive aseptic fill and finish services utilizing fully integrated isolator filling and advanced dosing systems for high yield filling.
Bausch + Ströbel VarioSys® Fill Line
Fully integrated, high-yield fill line featuring an integrated vial rinser and depyrogenation tunnel with line losses as low as 100mL and filled container yields of >99.8%.
Finished Product Manual Visual Inspection
100% manual visual inspection services complying with USP 790 to ensure packaging integrity and absence of particulate matter, including in-house Defect Kits.
Services
End-to-end aseptic vial filling, stoppering, sealing, and release for clinical and commercial projects, including compounding, in-process controls, and batch record review.
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.
Comprehensive AQC and MQC services including chromatography, spectroscopy, particulate analysis, endotoxin, bioburden, sterility, and microbial identification to support release and troubleshooting.
100% manual visual inspection per USP 790, AQL sampling, procedures for difficult-to-inspect products, and in-house defect kit production for inspector qualification.
Inventory management, vendor coordination, dual sourcing, and temperature-controlled storage and distribution to support fill/finish timelines and product integrity.
Regulatory operations and intelligence supporting CMC, manufacturing site transfers, global submissions, and lifecycle regulatory strategy.
End-to-end aseptic vial filling, stoppering, sealing, and release for clinical and commercial projects, including compounding, in-process controls, and batch record review.
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.
Comprehensive AQC and MQC services including chromatography, spectroscopy, particulate analysis, endotoxin, bioburden, sterility, and microbial identification to support release and troubleshooting.
100% manual visual inspection per USP 790, AQL sampling, procedures for difficult-to-inspect products, and in-house defect kit production for inspector qualification.
Inventory management, vendor coordination, dual sourcing, and temperature-controlled storage and distribution to support fill/finish timelines and product integrity.
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)