Gene Therapy and Viral Products cGMP Production

Advanced Therapies Facilities and Capabilities

We offer our partners highly flexible clinical and commercial cGMP facilities for the production, by microbial fermentation and cell culture, of biologics and gene therapies.

Our state-of-the-art facilities include:

  • The National Center for Therapeutic Manufacturing which is designed for Process Development and Phase I/II GMP production of gene therapies (Viral, Microbial, Plasmid)
  • The Flexible BioManufacturing Facility which is designed for cGMP production of Viral and Gene Therapy products Phase I-III and Commercial

Assets for every stage of product lifecycle

Our manufacturing assets will support your full product lifecycle – from pre-clinical development to commercial production.

  • Use of Mobile Clean Room Technology
  • Fully segregated and self-contained units
  • VHP-based cleaning and rapid change-over
  • Can connect MCRs together as needed (i.e., Upstream, Recovery, Downstream)
  • Near exclusive use of single-use technology, from cell bank to product vial
  • Fully functional Process and Analytical development, and Virology sections
  • Extensive Quality system, multiple clinical viral and non-viral bulks released
  • High-speed robotic viral product fill finish capabilities