SK pharmteco, a global contract development, manufacturing, and analytical testing organization serving the pharmaceutical and cell & gene therapy industry, is introducing 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 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: SK pharmteco’s 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 supporting cell therapy programs.

 
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.