SK pharmteco Expands Capabilities with New HPAPI Testing Lab

• SK pharmteco has launched a new analytical testing laboratory for High Potency Active Pharmaceutical Ingredients (HPAPIs) at its Rancho Cordova, California site.

• The state-of-the-art CGMP laboratory is fully operational and has successfully released its first Active Pharmaceutical Ingredient (API).

SK pharmteco, a global contract development and manufacturing organisation (CDMO), has announced the expansion of its capabilities with the launch of a specialised analytical testing laboratory dedicated to High Potency Active Pharmaceutical Ingredients (HPAPIs). The facility, located at the company’s Rancho Cordova, California site, is designed to enhance testing efficiency and ensure the safe handling of highly potent compounds.

The CGMP-certified laboratory strengthens SK pharmteco’s HPAPI operations, supporting both small molecule production and contract analytical testing services. The facility has already achieved a key milestone with the successful release of its first API. Joerg Ahlgrimm, CEO of SK pharmteco, stated, “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.”

Equipped with advanced testing capabilities, the laboratory supports analytical weighing, coulometric and volumetric water titration, UPLC with diode array detection, and gas chromatography with FID detection. Stringent containment measures include an isolator glove box, dedicated HVAC system, and exposure control down to 0.008 µg/m³ TWA, ensuring the highest safety standards for handling cytotoxic compounds.