Lyophilization process development
Robust and economical lyophilization processes developed by experts.
Lyophilization is the method of choice to achieve a stable drug product for many fragile (bio)pharmaceutical drug substances. For the development of robust and economical freeze-drying cycles suitable for large-scale production, we conduct a stepwise development program, tailored to the requirements of the product and the needs of our clients.
Our process development covers every step and is supported by our comprehensive lyo analytics
A comprehensive process development, all performed in-house.
At Coriolis, we have many years of experience in the development, optimization, scale-up and transfer of lyophilization cycles for (bio)pharmaceutical drug products. In our 400 m² lyophilization development center we operate a variety of freeze-dryers - from lab to production scale - and develop processes for many different drug products, including:
- protein-based formulations (including highly concentrated formulations)
- organic solvent containing formulations or
- live virus vaccines up to biosafety level 2
We can work with a variety of different primary packaging formats including vials, cartridges and bulk trays.
The development of a lyophilization process at Coriolis is accompanied by a large portfolio of process analytical technologies as well as additional lyo analytics to assure the highest drug product quality.