Man looking at a vial of fluid in the lab

Viral Vector Manufacturing

Viral Vector Manufacturing CDMO Services

Our purpose-built facilities is equipped with 9 dedicated viral vector suites, providing end-to-end capabilities ranging from plasmid manufacturing and first-time-right process development to high-throughput vector drug substance manufacturing and drug product filling, testing, and regulatory support.

Connect with us

High-Throughput Manufacturing

We’re committed to breaking down bottlenecks in viral vector manufacturing. With modular unit operations and continuous manufacturing, our teams deliver two to five times more batches per suite annually across a wide array of viral vectors. We consistently deliver high yields and higher throughput without compromising quality.

100% Commercial Ready

With facilities designed by former regulators to meet clinical and commercial quality standards, each suite supports both clinical and commercial supply to accelerate speed to market upon regulatory approval.

Flexible Partnerships

We are willing to put skin in the game with flexible capacity usage and milestone-based arrangements. Our Partner-in-Plant model enables onsite access to office space and production suites for hands-on involvement as your CGT program progresses.

Viral Vector and Gene Therapy Platforms

Learn more about our cell therapy manufacturing service

SK pharmteco offers our own proprietary viral vector and gene therapy platforms, capitalizing on decades of experience in viral vector production. Both LentiSure™ and AAVelocity™ are proven technologies, having already manufactured more than 230 viral vector batches. More than 100 of these batches supported clinical trials in the United States and Europe. Driven by a culture of quality and safety, our viral vector manufacturing experts have optimized these lentivirus and AAV platforms to reduce time to market for our client’s cell and gene therapy products.

The LentiSure™ Lentivirus platform

With an increasing number of cell therapies proceeding through clinical trials, the need for lentivirus manufacturing is more pressing than ever. SK pharmteco’s Lentisure platform offers lentiviral vectors with high productivity and all the necessary validated analytical methods to ensure a safe and effective cell or gene therapy product. LentiSure is a proven and optimized lentivirus manufacturing platform with a robust, scalable, and plug-and-play process. Created for both adherent and suspension processes, leveraging Lentisure provides a cost-effective, streamlined approach to accelerate your development and commercialization timelines.

The AAVelocity™ AAV platform

AAV is one of the most popular viruses utilized as a viral vector in cell and gene therapies. When used as a viral vector for cell and gene therapies, this non-integrating vector offers several benefits. Our AAVelocity platform is designed to provide a proven yet agile platform with steps that can be added or removed to maximize time- and cost-effectiveness while still offering the simplicity of a plug-and-play approach. Based on a HEK-293 cell line, AAVelocity is optimized to consistently deliver the highest quality and maximum yield of vector products. Shake flasks and single-use bioreactors are available for the suspension process of the platform.

Viral Vector Analytical Services

Our Analytical Accelerator™ Testing Platform speeds time to CGMP batch release more than three-fold and conserves sample volumes needed for testing by up to 50 percent.

Release, in-process, and characterization services include:

  • DNA concentration
  • Residual DNA analysis
  • Residual host cell protein (HCP) analysis
  • Residual host cell RNA analysis
  • pH, appearance, and compendial testing
  • Endotoxin testing
  • Viral vector purity (% supercoiled DNA) assessments
  • Agarose gel electrophoresis (total plasmid) analysis
  • Microbial cell bank testing
  • Empty versus full capsid 
  • Vector-specific testing platforms

We also offer advanced analytics and extended characterization, including plasmid sequencing using next-generation or Sanger sequencing methods.

Learn more about our world-class analytical capabilities

Contact us

We’re committed to supporting your development and manufacturing needs. Complete the form and someone from SK pharmteco will be in touch shortly.