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Selkirk Pharma Announces New APS Qualified Facility

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Selkirk Pharma, Inc., announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility and newly available fill/finish capacity. This development marks a significant milestone for the company in addressing industry bottlenecks and lack of U.S.-based manufacturing capacity, while offering exceptional clinical and commercial manufacturing services for small molecule and biologics drug sponsors.

The purpose-built aseptic manufacturing facility at Selkirk Pharma operates with leading-edge technology, including unidirectional material and personnel flow, single-use systems, SKAN isolator technology, and Bausch and Strobel VarioSys advanced dose filling systems. These ensure high quality and high yields, particularly vital for high-value biologics. Uniquely designed, the facility aligns with Annex 1 compliance standards, critical for clients targeting European markets, while also meeting the highest quality standards for U.S. markets. Unlike older facilities undergoing retrofitting to meet these standards, Selkirk Pharma's facility incorporates new technology designed from the ground up to be Annex 1 compliant.

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The new US based facility will be crucial in alleviating growing demands and capacity constraints within the fill/finish industry.

“The completion of our facility's aseptic process simulation qualification is a milestone achievement for the Selkirk team,” said John Bertagnolli, Vice President of Operations at Selkirk Pharma. “It was made possible by the hard work of our exceptional employees and through the support of many others. We are excited to offer this qualified, reliable, fill/finish capacity to our customers, and most importantly, to their patients.”