Making Formulations More Efficient Using the Freeze-Dry Microscopy Pre-Lyophilization Method
Jeffrey D. McGinn
Drug Development & Delivery - October 13, 2012
In the development of parenteral drugs, lyophilization, or freeze-drying, is a crucial process technology. Pharmaceutical manufacturers have traditionally found lyophilization to be a costly, complex, facility-intensive operation, even though it is a straightforward process at the lab level.
The market for lyophilized products is expected to grow significantly in the coming years. The flood of protein-based therapeutics and other injectable products being pushed through the drug development pipeline has contributed to the need for leaner, more efficient freezedrying methods. Without lyophilization, 60% of biotherapeutics, including recombinant proteins, plasma, vaccines, and antibodies, could not be commercially available. So, what kind of NMEs can be freeze-dried? See the following list:
• Non-biologicals (small molecules)
• Non-living biologicals such as:
Pharmaceutical formulators use freeze-drying to extend the shelf -life of their drugs, as many of these products have less than 2 years of shelf-life before they expire. One key step is to determine the right conditions for the freeze-drying process. Usually, formulators use largescale machines, which can make freeze-drying the most expensive and timeconsuming step in the parenteral manufacturing process.
To minimize cost and streamline this process, many companies developing new parenterals are finding it in their best interest to optimize their lyophilization cycles by looking at pre-lyophilization methods such as freeze-dry microscopy.