White Paper: The Scientific Path To Cycle Development

By Baxter Healthcare Corporation -- BioPharma Solutions

Management of medication delivery through lyophilization - freeze-drying - is a crucial enabling process technology for many important parenteral drugs. Close to 50% of biopharmaceuticals, including enzymes, proteins and monoclonal antibodies, must be lyophilized as these therapeutic agents are insufficiently stable for ready-to-use solution dosage forms. A small but growing number of small-molecule drugs are also prepared in this manner. It is a safe bet that without lyophilization, the majority of these products would not be available.

In solution, many drug substances are susceptible to even modest changes in temperature and chemical environment. These complex molecules undergo hydrolytic, oxidative, and aggregation reactions, compromising both potency and safety. Consequently, parenterals must often be distributed "cold-chained" - refrigerated or maintained frozen from manufacturing line to patient. Even then, freezing and/or thawing may cause some proteins to aggregate. Lyophilization overcomes poor stability by rendering labile drugs and proteins in a solid form more tolerant of long-term product storage.