Optimizing Lyophilization For Generics

All lyophilization processes have the same ultimate goal, to provide active and shelf-stable product in as safe and efficient a manner as possible. However each product intended for lyophilisation will have different specific formulation and processing requirements.

The development of products and processes for generic manufacture poses unique challenges. There is no longer the burden of proving efficacy through clinical trials, as with new drug development, but the expectation of lower prices and increased competition cause additional financial pressures. Product and process development must be completed as quickly and efficiently as possible without any resulting loss in efficiency in the final manufacturing processes. Unnecessary delays in development can delay launch to market, while inefficient manufacturing processes will add time and cost to a product in a market where the only differentiators are speed and price. Problems and setbacks must be resolved quickly to avoid losing market share or incurring further costs.