As biologics processes become increasingly productive, higher upstream titers can create new challenges in downstream processing, product quality, scale-up and manufacturing economics. In this webinar, our Process Development, Analytical Development and MS&T experts will present an integrated development case study, demonstrating how cross-functional collaboration supported the evolution from a conventional process toward a robust, high-yield manufacturing-ready platform.
Topics covered:
- USP intensification and its impact on DSP design and performance
- Platform analytical strategies supporting process decisions and product quality
- Scale-up, process robustness and technology transfer considerations
- Conventional vs. optimized process approaches and key COGS drivers
Why attend?
- Gain practical insights from an integrated biologics development program
- See how PD, AD and MS&T expertise can be combined across development and scale-up
- Learn how to balance yield and productivity with quality, robustness, scalability and manufacturing economics
Speakers
Michał Sobala, PhD, is Senior Director of Process Development at Rezon Bio, where he leads upstream and downstream development for biologics. His work focuses on process intensification, scalable manufacturing platforms and technology transfer, with particular emphasis on intensified fed-batch strategies and integrated USP/DSP development. Michał combines scientific expertise with operational leadership to improve process robustness, increase productivity and reduce manufacturing costs across development and manufacturing
Kamil Szala is a pharmacist and PhD candidate with experience in quality control and analytical research and development. He currently leads the Physicochemical Team within the Analytical Development Department at Rezon Bio. His work focuses on the development, optimization and implementation of physicochemical analytical methods, supporting robust analytical strategies throughout the development process.
Kamil Szala is a pharmacist and PhD candidate with experience in quality control and analytical research and development. He currently leads the Physicochemical Team within the Analytical Development Department at Rezon Bio. His work focuses on the development, optimization and implementation of physicochemical analytical methods, supporting robust analytical strategies throughout the development process.
