Due to the large quantity of development batches manufactured at our site, Baccinex has a thorough knowledge in industrial scale-up and adaptation of new process in compliance with regulatory requirements (GMP…). We have the expertise for rapid and successful completion for scale-up of a new process.
Thanks to its expertise in the field of lyophilisation, Baccinex can propose the following activities:
- Development or optimization of freeze-drying cycles
- Consultancy for transition from research laboratory to GMP environment
- Scale-up and optimisation of production processes
- Compatibility / adsorption studies with filter / medical devices