A CENTER OF EXCELLENCE FOR LYOPHILIZATION
Optimizing lyophilization cycle times and improving stability for complex injectables is a critical component of parenteral product development. Operating at the forefront of lyophilization optimization, we maintain the industry-leading Lyophilization Center of Excellence (LCOE), co-located with Baxter’s facility in Bloomington, Indiana, USA. The Center offers considerable expertise in refining freeze-drying techniques. LCOE scientists and affiliated staff can work with you to make process modifications and adjust formulas to capitalize on the full potential of your lyophilized products.
ADVANTAGES OF OUR APPROACH
Our “quality-by-design,” or “design space,” approach to freeze-drying cycle development has significant advantages over more traditional trial-and-error approaches. It reduces both the amount of active pharmaceutical ingredient and the time required for development, includes edges of failure to help ensure pharmaceutically acceptable product, facilitates handling of deviations and provides experimentally determined residual moisture specification.
CUTTING-EDGE CAPABILITIES, CUSTOMIZED SERVICE
We use state-of-the-art instrumentation for the detection of aggregation and other physical stability issues and the latest analytical methodologies for protein biophysical characterization and measurement of protein aggregates. To minimize handling and microbial exposure during production, we offer robotic loading and unloading of lyophilizers.
Ultimately, our approach to lyophilization helps to identify the fastest possible robust lyophilization cycle in order to reduce manufacturing cost. And as always, we offer customized service, whether you have not yet developed a lyophilization cycle for your product’s formulation or recognize a need to shorten or enhance it.
Is Mannitol Hemihydrate Detrimental to Protein Stability Assessing Mannitol Crystallinity in Lyophilized Drug Products
Learn from the BioPharma Solutions team under what conditions MHH dehydrates and how the dehydration impacts protein stability.View resource
Vial Breakage During Lyophilization
Learn more from the BioPharma Solutions team on the Root Causes and Mitigation Strategy for Vial Breakage during Lyophilization.View resource
Importance of Assessing Mannitol Crystallinity in Lyophilized Drug Products
When mannitol is used as an excipient in a lyophilized drug product, assessing its crystallinity is important because drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.View resource