Manufacturing of drug product
The drug product manufacturing facility is designed to produce injectable biopharmaceuticals in syringes or vials in a Grade A environment. The fill and finish manufacturing line bulk frozen or liquid drug substance from own or other plants, which are thawed (if case frozen substance), prepared with the preservatives, buffering agents, pH adjusters, and filled into sterile nested vials or syringes being packed and shipped. Capability of the filling machine is up to 4000 containers per hour at filling volume from 0.2 ccm to 2 ccm. Installed freeze dryer can perform lyophilisation of the drug product in vials up to 2000 vials per batch.