PD-Direct® Bioprocess Services brings streamlined process development solutions to your project, helping you to:
- Reduce risk, time, and costs through integrated services
- Enhance productivity, scalability, and reliability for cGMP production
- Broaden access to industry-leading technologies with a trusted partner
Design of a suitable production system for manufacturing takes into account the selected expression system, phase of drug development, intended manufacturing facility, and scale and production requirements.
The prototype production process is typically evaluated at sub-scale or bench-scale levels. The results from this study lead to a development plan for those operations that need additional optimization.
Upstream Development and Optimization
Characterization and optimization of upstream portions of the process span from cell expansion to bioreactor harvest, including cell growth and production phases. Optimizing upstream performance can include refining cell growth conditions, media or production conditions, and feeding strategies, as well as harvest studies.
Using high-throughput combinatorial systems, such as SimCell™ and MediaMaker technologies, within a DOE (design of experiment) approach, we are able to perform simultaneous analyses on dozens of factors influencing your cell culture system to identify the optimal nutritional and process conditions for your platform.
Our Media ADVANCE™ process - a complete workflow around media and feed optimization - will help you to achieve true performance improvements in your upstream process.
Learn more about Media ADVANCE™
Downstream Development and Optimization
Characterization and optimization of recovery and yield of downstream unit operations includes cell lysis, clarification, product concentration, buffer exchange, and purification. Key parameters relevant to each unit operation are investigated.
The optimized production process is tested at the sub-scale level from cell thaw to bulk drug substance. The results lead to a technology transfer plan for those operations that need additional optimization for scalability and process robustness.
- Miniaturization enables larger, more thorough DoE
- Makes finding robust media and process solutions faster