Life Sciences

SK pharmteco Launches New Lentiviral Vector Analytical Services with Dedicated 20,000 sq. ft. Facility

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Dana Cipriano, Global Head of Analytical Services, cuts the ribbon to mark the opening of SK pharmteco’s state-of-the-art 20,000-square-foot CGMP testing facility at SK pharmteco’s King of Prussia campus. The facility is the future home of SK pharmteco’s Lentiviral Vector (LVV) Analytical Services, a comprehensive suite of analytical testing solutions specifically designed for LVV and cell therapy programs.

SK pharmteco, a global contract development, manufacturing, and analytical testing organization serving the pharmaceutical and cell & gene therapy industry, today announced the upcoming launch of Lentiviral Vector (LVV) Analytical Services, a comprehensive suite of analytical testing solutions specifically designed for LVV and cell therapy programs. Coinciding with the launch is the commissioning of a new, state-of-the-art 20,000-square-foot CGMP testing facility, located on SK pharmteco’s King of Prussia campus, with dedicated laboratory space specifically designed for replication-competent lentivirus (RCL) testing and molecular based analytics.  The full platform is available for R&D testing now, with full CGMP testing capabilities in July 2024. 

“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,” said Dana Cipriano, Global Head of Analytical Services for SK pharmteco. “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.” 

Key Features of SK pharmteco’s LVV Analytical Services include: 

  • Full global CGMP Testing Capabilities: SK pharmteco provides a complete package of analytical development, characterization, release, and safety testing services, all performed under Current Good Manufacturing Practices (CGMP) guidelines.  This includes adventitious agent testing, sterility, and advanced analytical methods such as sequencing. 
  • Extensive Platform Assays: Clients have access to over 30 platform assays specifically designed for viral vector and cell therapy programs, streamlining development timelines. 
  • Unparalleled Replication Competent Lentivirus (RCL) Virus Testing: SK pharmteco is committed to patient safety by offering the complex RCL assay, a critical step in ensuring the absence of replication-competent lentivirus in cell and gene therapy products. Being able to offer this labor-intensive assay will eliminate testing backlogs and guarantee timely results for our clients.    
  • Flexible Support: Our team offers comprehensive analytical development, qualification, and validation services to support potency, product-specific assays, and stability programs for a customized approach to each client’s needs. 
  • Rapid Testing Technologies: SK pharmteco utilizes cutting-edge, rapid testing technologies for in-process and release testing, further accelerating development timelines and demonstrated success to support cell therapy programs. 

Commitment to Patient Safety and Client Success 

The launch of LVV Analytical Services builds on SK pharmteco’s capabilities to fully support, cell and gene therapy manufacturing. This strategic move strengthens SK pharmteco’s ability to offer a complete end-to-end solution for Lentiviral Vector and cell therapy products. 

“By combining our extensive analytical expertise with our robust manufacturing capabilities, we are uniquely positioned to support the development of lifesaving cell and gene therapies,” said Joerg Ahlgrimm, CEO of SK pharmteco. “This close collaboration with clients clears development roadblocks and ensures faster access to life-changing treatments.”