Process Development
Successful process development enables a smooth and rapid path from cell strain selection to cGMP product delivery. The Process Development team designs scalable manufacturing processes to support Phase I – III clinical trials and assesses how robust a process is, how it behaves as conditions are altered, and what the critical factors are for success.
We utilize well-established protocol-based technology transfers to bring in customer developed processes; alternatively, we can employ the efficient processes developed and/or optimized by our own process development scientists.
Our team is highly experienced in determining equipment and facility fit, as well as optimization of individual steps in an existing set of unit operations to confirm the overall process is best-suited for scale up and cGMP production.
Preparing for cGMP Manufacturing
Our process development scientists take a modular, Design of Experiment (DOE), based approach to develop optimal fermentation and product recovery processes as well as downstream purification steps. Methods, such as high cell density fermentation, are used to increase product yield and manufacture high quality product in an efficient manner.
The Process Development group works hand-in-hand with our Analytical Technologies group to ensure the integrity of your molecule each step of the way. When the phase-appropriate process is fully developed, the complete manufacturing method is seamlessly transferred to the cGMP Manufacturing group to initiate scale-up manufacturing.
Key Services
Our development teams ensure the integrity of your molecule when transferring, optimizing or developing efficient upstream and downstream processes.
- Vector design
- Strain selection
- Media optimization
- Fermentation
- Harvest
- Primary recovery
- Capture and polishing chromatography
- Inclusion body preparation
- Refolding and filtration operations
- Client process technology transfer and optimization
- Identification of critical process parameters
- Development of process control strategies
Equipment
Fermentation and Primary Recovery Equipment
- 5 L fermenters
- Dead end and continuous centrifugation
- Homogenizer
- Microfiltration
- Ultrafiltration/diafiltration
Purification Equipment
- AKTA Explorer and Purifiers
- Ultrafiltration/diafiltration
