Scaling-up can be an ongoing challenge for manufacturers, particularly for lyophilized biologic drugs. Differences in freeze-drying equipment performance, controls system and operation can occur between development and production scales, leading to time consuming and costly re-optimizations of lyophilization parameters to achieve successful freezedrying of the product.
One area of lyophilization, that in the past required a considerable amount of trial-and-error, is cycle development. It is important to understand much of the basic information required for cycle development and incorporate them into your product’s development from the initial research stages to large scale manufacturing.
Improve the empirical nature of cycle development with SP’s Line of Sight (LoS) suite of technologies, process analytical technology (PAT) tools and equipment design. Learn more about SP’s latest lyophilizer, the SP Hull LyoStar® 4.0 for rapid lyophilization cycle development, optimization and scale-up.