Lyophilization / Freeze drying cycle
Eurofins CDMO (Contract Development Manufacturing Organization) network of companies offers capacities for lyophilized Drug Products.
Lots of APIs are not stable in aqueous phase and need to follow a sharp and deep galenic study to maintain it stable for a sustainable period of time. This period shall be extended for improvement of scalability and commercial sustainability.
We designed our sterile manufacturing service portfolio to support this particular improvement and move your API to a higher stage in stability performance. Our development laboratories are equipped with the latest state of the art labscale freeze dryers.
Choose Eurofins CDMO to help you in:
? Formulation transition from liquid to freeze dry form
? Solubilization and formulation study for injection
? Freeze drying cycle optimization (cost reduction)
? Freeze drying cycle development
All these tasks can be customized to your needs and shall be performed for any type of API including:
- HP API and Cytotoxics up to OEL 4
- BSL 2 products
- Regulated molecules (Opioids….)
- Standard molecules
Once the development stage has been achieved, we are committed to manufacture your clinical stage material at pilot scale up to your phase 3 capacity requirements or for commercial scale dedicated to Orphan Drug supply.
