Gilyos Services
Gilyos Service

Scale-Up of Freeze-Drying Cycles

One of the greatest obstacles in freeze-drying is scale-up of laboratory experiments to pilot or production. First, this transfer typically implies a change from non-GMP to class 100 conditions which greatly affects the “freezing behavior” of the product. Even if laboratory experiments are performed under GMP, one of the biggest problems to overcome is the difference in design and performance of the equipment. Only thorough characterization of both formulation and process, along with the understanding of heat and mass transfer and implementation of complementary PAT, is the right basis for successful scale-up.

Examples of services which GILYOS offers to customers are as follows: identification of a Contract Manufacturing Organization (CMO) for your product, scale-up from our site to the desired CMO production site, Operational Qualification, performance testing, troubleshooting for manufacturing processes in small scale.

Gilyos Service
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