Controlled, Continuous Lyophilization: Faster Development, Flexible Manufacturing
Workshop
2026-05-27 | 04:00 PM - 04:35 PM | The Innovation Corner
Abstract
Dr. Thomas De Beer presents on continuous and controlled freeze-drying for biopharmaceuticals under GMP. His talk highlights how integrating process analytical technology (PAT) into freeze-drying can transform this critical step from a traditional batch-based operation into a continuously monitored, data-driven, and controlled process. By enabling real-time measurement and improved process understanding, this approach supports greater efficiency, product quality, and regulatory confidence. The presentation forms part of a broader discussion on advancing biomanufacturing through innovation, digitalization, and stronger collaboration between industry, academia, and regulatory authorities.
Dr. Giuseppina Salzano presents on the Thermo Fisher Scientific’s Monza site, a strategic Center of Excellence within its global CDMO network. The site has further strengthened its injectable drug development capabilities through a partnership with RheaVita, introducing controlled and continuous lyophilization technology.
Established in 2020, the Formulation & Analytical Development laboratory (FD lab) was purpose-built to enable seamless scale-up to GMP manufacturing lines and is supported by advanced, innovative capabilities for the safe handling and processing of highly potent and sensitive materials, as well as the production of scalable endotoxin-free toxicological batches. Several ad hoc studies are strategically designed to support drug development from early formulation design through process optimization and scale-up.
With expertise spanning both conventional and complex sterile formulations, including suspensions and highly viscous solutions, both liquid and lyophilized.
Monza accelerates development timelines, reduces scale-up risk, and delivers innovative freeze-drying solutions through both traditional batch processes and RheaVita’s continuous lyophilization technology.
