SK pharmteco, a global contract development and manufacturing organization (CDMO), has launched an enhanced analytical testing laboratory specifically dedicated to High Potency Active Pharmaceutical Ingredients (HPAPIs).

Located at SK pharmteco’s Rancho Cordova, California site, the CGMP laboratory is a significant addition to the site’s current HPAPI laboratory operations. Designed for the safe handling of potent chemicals for CGMP testing and release, the lab is now fully operational and has already achieved a significant milestone: the successful release of its first Active Pharmaceutical Ingredient (API).

“We are excited to expand our capabilities and provide more efficient testing solutions for our customers,” said Joerg Ahlgrimm, CEO of SK pharmteco. “This expansion underscores our steadfast commitment to safety, innovation, and providing a seamless and customer-centric experience, particularly as compounds under development become increasingly more potent.”

The new laboratory builds on the site’s current HPAPI capabilities and provides an increase in controlled environment for the Quality Control and Analytical Method Development teams to handle highly potent and cytotoxic compounds. In addition to supporting the organization’s small molecule production programs, the laboratory is also available for contract analytical testing services.

The laboratory boasts advanced testing capabilities for highly potent compounds, including UPLC, GC, and titration.  It also features stringent containment and safety measures, such as an isolator glove box and negative pressure HVAC.

With decades of experience in scaling HPAPI processes from clinical to commercial production, SK pharmteco enables the development and manufacture of life-changing medicines.

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