Selkirk Pharma, Inc., a privately held U.S. pharmaceutical producer specializing within the fill and end of injectable medication, together with vaccines and organic therapeutics, as we speak introduced the Aseptic Course of Simulation (APS) qualification of its sterile manufacturing facility and newly obtainable fill/end capability. This improvement marks a major milestone for the corporate in addressing business bottlenecks and lack of U.S.-based manufacturing capability, whereas providing distinctive medical and business manufacturing providers for small molecule and biologics drug sponsors.
The aim-built aseptic manufacturing facility at Selkirk Pharma operates with modern know-how, together with unidirectional materials and personnel stream, single-use programs, SKAN isolator know-how, and Bausch and Strobel VarioSys superior dose filling programs. These guarantee top quality and excessive yields, notably very important for high-value biologics. Uniquely designed, the ability aligns with Annex 1 compliance requirements, important for shoppers focusing on European markets, whereas additionally assembly the best high quality requirements for U.S. markets. In contrast to older services present process retrofitting to satisfy these requirements, Selkirk Pharma’s facility incorporates new know-how designed from the bottom as much as be Annex 1 compliant.
The brand new US primarily based facility will likely be essential in assuaging rising calls for and capability constraints throughout the fill/end business.
The completion of our facility’s aseptic course of simulation qualification is a milestone achievement for the Selkirk group. It was made attainable by the onerous work of our distinctive staff and thru the help of many others. We’re excited to supply this certified, dependable, fill/end capability to our prospects, and most significantly, to their sufferers.”
John Bertagnolli, Vice President of Operations at Selkirk Pharma
