Home Medizin Selkirk Pharma kündigt neue APS-qualifizierte Anlage mit erweiterter Abfüll-/Endkapazität in Spokane, WA an

Selkirk Pharma kündigt neue APS-qualifizierte Anlage mit erweiterter Abfüll-/Endkapazität in Spokane, WA an

von NFI Redaktion

Selkirk Pharma, Inc. is a privately owned US pharmaceutical manufacturer specializing in the filling and final processing of injectable medicines, including vaccines and biological therapeutics. Today, the company announced the qualification of its sterile production facility and the availability of new filling/end capacities for aseptic process simulation (APS). This development marks a significant milestone for the company in addressing industry bottlenecks and the lack of production capacity in the US, while also providing exceptional clinical and commercial production services for small molecule and biologics sponsors.

The specially constructed aseptic production facility at Selkirk Pharma operates with state-of-the-art technology, including unidirectional material and personnel flow, disposable systems, SKAN isolator technology, and advanced dose filling systems from Bausch and Strobel VarioSys. These ensure high quality and high yields, crucial for high-value biologics. The facility is uniquely designed and complies with Annex 1 standards, crucial for customers targeting European markets, while also meeting the highest quality standards for the US markets. Unlike older facilities undergoing retrofitting to meet these standards, Selkirk Pharma’s facility features new technology designed from the ground up to comply with Annex 1.

The new facility, located in the US, will be crucial in addressing the growing demands and capacity bottlenecks in the filling/final processing industry.

The completion of the qualification of our aseptic process simulation facility is a milestone for the Selkirk team. This was made possible through the hard work of our exceptional staff and the support of many others. We are pleased to be able to offer our customers, and especially their patients, this qualified, reliable filling/end capacity.

John Bertagnolli, Vice President of Operations at Selkirk Pharma

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