PDMax™ Process Development & OptimizationSource: Xcellerex
To provide rapid development of optimized processes for its FlexFactory™ biomanufacturing platform and XDR™ disposable bioreactors, Xcellerex offers PDMax™, a high throughput (HT) process development and optimization platform. This capability is essential for achieving process productivity levels that will support commercial production of biologics using single-use biomanufacturing technologies.
PDMax can be used to select an optimized cell line, growth media, feed strategy, bioreactor parameters, and purification and formulation strategies. Once determined, these optimized conditions can then be tested at Xcellerex in bench scale bioreactors to demonstrate process reproducibility and scalability.
PDMax was created to shorten development timelines, increase the breadth of process data, and insure the highest probability of finding conditions for maximum yield and optimal process performance. PDMax™ employs innovative protocols and high-speed, high-throughput automation technology to streamline each of the critical steps in bioprocess development.
These tools and techniques are combined with classical process development approaches, statistical design of experiments and high-throughput analytical techniques to quickly and thoroughly map the experimental space and focus resources on the most promising results.
What is possible with PDMax
Advantages of PDMax
- Highest possible expression for any cell/product
- Very fast process optimization
- Thousands of process variables can be examined
- Generate more robust manufacturing processes
- Avoidance of Phase II to Phase III process changes
- Product comparability preservation during scale up