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, immediately introduced the Aseptic Course of Simulation (APS) qualification of its sterile manufacturing facility and newly obtainable fill/end capability. This growth marks a big milestone for the corporate in addressing trade bottlenecks and lack of U.S.-based manufacturing capability, whereas providing distinctive scientific and business manufacturing companies for small molecule and biologics drug sponsors.
The aim-built aseptic manufacturing facility at Selkirk Pharma operates with modern expertise, together with unidirectional materials and personnel stream, single-use methods, SKAN isolator expertise, and Bausch and Strobel VarioSys superior dose filling methods. These guarantee top quality and excessive yields, significantly important for high-value biologics. Uniquely designed, the power aligns with Annex 1 compliance requirements, crucial for purchasers concentrating on European markets, whereas additionally assembly the very best high quality requirements for U.S. markets. Not like older amenities present process retrofitting to fulfill these requirements, Selkirk Pharma’s facility incorporates new expertise 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 trade.
The completion of our facility’s aseptic course of simulation qualification is a milestone achievement for the Selkirk crew. It was made potential by the arduous work of our distinctive workers and thru the assist of many others. We’re excited to supply this certified, dependable, fill/end capability to our clients, and most significantly, to their sufferers.”
John Bertagnolli, Vice President of Operations at Selkirk Pharma
Supply hyperlink
