cGMP Manufacturing
We have been performing cGMP manufacturing of biologics for over 17 years including production of over 30 monoclonal antibodies and non-antibody proteins.  CMC’s manufacturing professionals, many with more than 20 years industry experience, will provide energy, enthusiasm, and drive to help you achieve your project goals.  Our on time delivery record, commitment to quality, and expertise in developing efficient production processes puts your project in the best position to succeed.

Capabilities

• Master Cell Bank and Working Cell Bank production and storage
• Pilot-scale facilities (150L) for production of non-clinical and Phase I lots
• Versatile range of bioreactors for cGMP production from 100L to 3000L
• Clinical and commercial manufacturing of drug substance
• Batch, fed-batch, and perfusion processes
• High-level product expression in mammalian cells
• 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 U.S., Canada, Europe, Asia, and Australia