We have extensive experience with cGMP manufacture of biologics, including the production of more than 80 monoclonal antibodies and non-antibody proteins. Our highly experienced manufacturing professionals provide the energy, enthusiasm, and drive to help our clients achieve their project goals. In addition, our on-time delivery record, commitment to quality, and expertise in developing efficient production processes puts your project in an optimal position to succeed.
Capabilities
- Master cell bank and working cell bank production and storage
- Pilot-scale facilities for production of nonclinical lots
- Versatile range of bioreactors for cGMP production from 100L to 3,000L
- Clinical and commercial manufacturing of drug substance
- Batch, fed-batch, concentrated fed-batch, and perfusion processes
- High-level product expression in mammalian cells
- Platform processes; e.g., for antibodies in CHO
- Production-scale chromatography techniques
- Experience replicating existing processes and implementing customized processes
- Process engineering and design support
- Extensive experience developing regulatory submissions for clinical products in the
United States, Canada, Europe, Asia, and Australia