SK pharmteco Unveils 20,000 sq ft CGMP Testing Facility in Pennsylvania

• SK pharmteco introduces Lentiviral Vector (LVV) Analytical Services 20,000 sq ft CGMP testing facility launched in King of Prussia, PA.

• Full CGMP testing capabilities available from July 2024.

SK pharmteco, a global contract development, manufacturing, and analytical testing organisation, has introduced Lentiviral Vector (LVV) Analytical Services. This suite of solutions is specifically designed for LVV and cell therapy programs. Coinciding with this launch, a new 20,000-square-foot CGMP testing facility has been commissioned at SK pharmteco’s King of Prussia campus.

The new facility features dedicated laboratory space for replication-competent lentivirus (RCL) testing and molecular-based analytics. While the full platform is now available for R&D testing, complete CGMP testing capabilities will commence in July 2024.

Dana Cipriano, Global Head of Analytical Services for SK pharmteco, emphasised the industry’s growth: “The cell and gene therapy industry is experiencing tremendous growth, and the demand for robust analytical testing is critical to ensure patient safety and program success. These new services, combined with our dedicated lab space, allow clients unparalleled access to SK pharmteco’s robust testing platform assays and scientific expertise, with the capacity and capabilities to eliminate backlogs and expedite development timelines. We are committed to our clients, and having this platform demonstrates that commitment.”

SK pharmteco’s LVV Analytical Services include full global CGMP testing capabilities, encompassing analytical development, characterization, release, and safety testing services under Current Good Manufacturing Practices (CGMP) guidelines. The extensive platform assays, with over 30 specifically designed for viral vector and cell therapy programs, aim to streamline development timelines.

The new services also provide RCL virus testing, a critical step in ensuring the absence of replication-competent lentivirus in cell and gene therapy products and analytical development, qualification, and validation services to support cell therapy programs.