FOR IMMEDIATE RELEASE
Rancho Cordova, CA (February 12, 2025) — SK pharmteco, a global contract development and manufacturing organization (CDMO), today announced the expansion of a core competency with the launch of an enhanced analytical testing laboratory specifically dedicated to High Potency Active Pharmaceutical Ingredients (HPAPIs).
Located at SK pharmteco’s Rancho Cordova, California site, the state-of-the-art CGMP laboratory is a significant addition to the site’s current HPAPIs’ 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 a 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’s notable features include:
• Advanced Testing Capabilities:
o Equipped to handle Highly Potent Compounds with Occupational Exposure Limits (OEL) to Band 5
o Analytical Weighing
o Coulometric & Volumetric Water Titration
o UPLC with Diode Array Detection
o Headspace & Direct Inject Gas Chromatography with FID Detection
• Stringent Containment & Safety Features:
o Isolator Glove Box with inertion, washdown, & sample transfer capabilities
o Exposure Control down to 0.008 µg/m3 TWA (qualified via independent third-party surrogate testing)
o Dedicated HVAC maintaining negative pressure to the antechamber
o Sample passthrough port for laboratory isolation
o Dedicated gowning & de-gowning rooms with misting wash down decontamination
With decades of experience in scaling HPAPI processes from clinical to commercial production, SK pharmteco brings unmatched expertise and capacity to support customers at every stage of development and reinforces its position as a trusted partner in the pharmaceutical industry, enabling the development and manufacture of life-changing medicines.
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About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with production sites, research & development facilities, and analytical laboratories across the U.S., Europe, and Korea. The company partners with biopharmaceutical companies of all sizes to manufacture Active Pharmaceutical Ingredients (API) and intermediates, cell and gene therapy technologies, registered starting materials, and analytical services for the biopharmaceutical industry worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.
Contact:
Keith Bowermaster, APR, CCMP
Communications Consultant
keith.bowermaster@skpt.com
Website: www.skpharmteco.com
SOURCE: SK pharmteco