Lyophilization

PrimaPharm offers a range of lyophilization services from clinical to commercial scale through an alliance with several San Diego life sciences companies.  If you have an existing lyophilization process, we will work with you to transfer and adapt your lyophilization cycles to our equipment.  If your optimal lyophilization cycle has not been determined, PrimaPharm can develop a lyophilzation process specifically for your product with our in-house analytical expertise.

PrimaPharm will be offering in-house lyophilization services that allow for clinical to commercial scale production by the third quarter of 2015.  We have purchased a Hull 54 sf unit that is being situated in a Class 100 clean room and equipped with clean-in-place and steam-in-place capabilities.  The lyophilizer will accommodate programmable recipes for lot-to-lot repeatability.  This clean room will also house a Flexicon FPC50 fully-automated aseptic filling system capable of filling up to 10,000 unit batch sizes.  The filling system will be integrated into a Walker Restricted Access Barrier System (RABS).