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.
To get your antibody produced Right. On Time. view our 2.012 product brochure!
- 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