Abstract: In solution, many drug substances are susceptible during processing, storage and small changes in temperature and environment, thereby triggering many degradation pathways. Highly complex injectables, whether small or large molecule, undergo degradation pathways that may include hydrolytic, oxidative, and aggregation reactions, compromising both potency and safety. In addition, injectables are often distributed “cold-chained,” either refrigerated or maintained frozen from storage to patient. Some injectables may also exhibit susceptibility to freezing and/or thawing. Lyophilization overcomes poor stability by rendering labile drugs and proteins in a solid form more tolerant of long-term product storage. This webinar “Development of Lyophilization Cycle for Improving Stability of Complex Injectables” is designed as an introduction to a program, taking in account varying freezing rates of buffers, excipients, their chemical effect and the physical dynamics of controlled process values within the art / science nature of lyophilization cycle development. Highlights of this webinar include developing:

• Lyophilizable formulation matrix
• Lyophilization parameters by understanding thermal properties of the lyophilizable matrix
• Lyophilization cycle for transfer, scale up and GMP manufacturing