Case Study: Using Freeze-Drying Microscopes (FDM) To Improve Cycles

By Biopharma Technology Limited

A customer approached BTL with a product that was being freeze-dried using a generic cycle (which was applied to a number of other products). It was failing to meet the required moisture threshold (no more than 2%) and each batch was therefore rejected. FDM analysis was proposed to ascertain the lyophilisation behaviour of the product and to see if any improvements could be made on the existing cycle.