State of the Art Biologics Commercial Manufacturing
Using Single-Use Technology
Our state of the art biologics manufacturing facility, in Madison, WI, utilizing single-use systems offers flexibility and scale to support your growth. We offer a broad range of integrated, process development and analytical services to solve your most difficult development and biologics manufacturing challenges.
Whether you are using a Catalent GPEx® technology-based cell line or your own cell line, we can design a robust production process capable of reliably producing your biologic under a rigorous cGMP environment. All operations, from cell line development through commercial manufacturing, can be performed in a single facility, led by a dedicated project manager. This continuity provides more reliability and peace of mind for your biologics manufacturing.
EXPANDED MANUFACTURING CAPACITY
Catalent Biologics is expanding capacity at the Madison, Wisconsin facility with additional 22,000 sqft of space to support late-phase clinical and commercial production.
The new manufacturing suite will house a 2x2000L single use bioreactor system capable of producing 2000L or 4000L batches, and will be available by October 2017. The new footprint will also support expansion of analytical and process development laboratories to meet future demands.
- Process development with extensive non-GMP and GMP experience
- Upstream process development in shake flask and bioreactor systems (2L – 10L)
- Downstream process development at the milligram to 100s kilogram scale
- Scale down and non-cGMP production (up to 250L) in single use bioreactors
- ambr® system for fast process development/optimization
- Flexible cGMP production scale from 10 L to 4000 L
- Co-located analytical laboratory to support method development, in-process, release and stability testing
- Tailored process development for non-GPEx cell lines
- Extensive use of single use technologies to eliminate cross contamination
- Unidirectional flows throughout facility
- Global Catalent Quality System – inspection performance 2x better than industry average
- Proven experience working with a wide variety of molecules, including; antibodies, fusion proteins, antibody fragments, and other complex recombinant proteins