CDMO SK pharmteco has expanded its service offering by launching a novel HPAPI analytical testing laboratory at its Rancho Cordova, California site.
The new cGMP laboratory is suitable for the safe handling and testing of potent chemicals, with occupational exposure limits to band 5.
SK pharmteco can also offer its clients analytical weighing services, as well as colourimetric/volumetric water titration, UPLC with diode array detection and inject gas chromatography with FID detection.
The laboratory is also built to ensure that potent compounds are correctly contained, significantly reducing the chances of contamination and ensuring staff safety. Safety features of the site include:
- An isolator glove box with inertion, washdown and sample transfer capabilities
- Exposure control with TWA as low as 0.008 µg/m3
- Sample passthrough port for the laboratory isolation of HPAPIs
- Dedicated gowning and de-gowning rooms with misting washdown for decontamination
- Dedicated HVAC that maintains negative pressure in the antechamber
SK pharmteco's new laboratory builds on the California site's current HPAPI handling capabilities, allowing the company to better provide its customers with quality control and analytical method development services.
The laboratory will be used to support the company's small molecule production programmes, as well as customers looking for a contract analytical testing service.
“We are excited to expand our capabilities and provide more efficient testing solutions for our customers,” said CEO of SK pharmteco, Joerg Ahlgrimm.
“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.”