News from DCAT Week 2022: Selkirk Pharma Expanding Injectables MfgBy
Selkirk Pharma, a Spokane, Washington-based CDMO of injectable drugs, announced plans to expand manufacturing capacity by adding two additional production lines at its facility in Spokane. Selkirk specializes in the manufacture (fill–finish) of injectable drug products. John Bertagnolli, Vice President and Head of Commercial Operations, Selkirk Pharma, provided the update on behalf of Patrick Haffey, CEO.
Selkirk previously constructed a greenfield facility in Spokane and is in the process of qualifying its first manufacturing line for both commercial and clinical trial drugs. The two new additional filling lines will be constructed within the previously built gray shell space inside the company’s existing facility. GMP production on Line 1 is scheduled to begin in the first quarter of 2023. Start of GMP production on Lines 2 and 3 is scheduled for 2025.
The two new production lines are functional replicas of Selkirk’s Line 1, each with flexible filling systems capable of filling both vials and syringes. All three production lines will have lyophilization capabilities as well. Each line is capable of producing 15 million units annually, for a plant capacity of 45 million units.
Selkirk selected the Variosys production system, designed and manufactured by Bausch + Stroebel and SKAN. The equipment will work with Selkirk’s digital platform for electronic batch records, quality systems, and building automation.
Selkirk’s existing building and its Production Line 1 were designed and built to maintain unidirectional flow throughout the manufacturing area. This unidirectional flow is continued for the expanded cleanroom space, and each production line is supported by independent air handlers.
The three identical filling lines are capable of producing in vials, syringes, and lyophilization, are housed in isolated, unidirectional filling suites, and use identical paperless documentation systems.