Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Page 25 of 61

26 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Optimizing Lyophilization L yophilization, or freeze-drying, came into prominence dur- ing the 1940s after early experiments in the mid 1930s at the University of Pennsylvania, when it was used to prolong the stability of blood plasma and treatments such as penicillin, allowing them to be shipped long distances without losing efficacy. The process has been a mainstay of the pharmaceutical industry ever since and has become essential to biopharmaceutical manufactur- ing, as treatments such as monoclonal antibodies assume greater importance. Currently, more than half of the injectable drugs sold have been lyophilized. Lyophilization involves removing solvent such as water from a substance by first freezing and then sublimating the ice to vapor. The three stages of the process are freezing, primary drying, and secondary drying. Despite its importance, the process itself has seen relatively little change since it was introduced decades ago, even though process understanding has improved by leaps and bounds. This has led to a disconnect between current practice and market needs. LyoHub, a consortium of pharma and biopharmaceutical manufacturers, equipment designers and suppliers, researchers, and academics with participation from regulatory bodies, headquartered at Pur- due University, is trying to address this problem. The group has established a Technology Roadmap, prioritizing efforts and areas for improvement (1). In 2017, the group published best practices for instrumentation (2). LyoHub is now working with the American Society for Testing and Materials International's (ASTM's) E-55 Committee to make these best practices into industry standards. Can Standards Help Pharma Modernize Lyophilization? Agnes Shanley ASTM's E-55.05 committee aims to turn best practices into industry standards in order to eliminate variability and allow a 70-year-old process to leverage 21st century tools, technologies, and practices. PHOTO COURTESY OF JENNIFER GREY, LYOHUB, PURDUE UNIVERSITY

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