Shortages of Injectable Drugs: Manufacturing Issues and Potential Solutions
Friday, September 12, 2014
10:00 a.m.-11:00 a.m.
FDA-White Oak Bldg. 2 Room 2031
Lori Herz, Ph.D. Professor of Practice, Chemical Engineering
Lehigh University, Bethlehem, PA
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Drug shortages have been a serious concern in the healthcare community for the past several years, sometimes impacting the care of the patients who need these products. The majority of drugs affected by shortages are injectables, and, of those, most are produced by generics manufacturers. The causes of this problem are numerous, and include both manufacturing issues and economic constraints. Manufacturing challenges associated with finish and fill operations for sterile products include the need for specialized facilities, as well as stringent controls and production conditions. Additionally, economic concerns have resulted from a competitive market, as well as the small number of manufacturing facilities capable of producing injectables. The FDA has taken actions to mitigate the shortages, such as asking other companies to increase production, expediting review, and increasing staffing. The aims of this seminar are to discuss common technical issues during the manufacture of injectable products, suggest approaches for troubleshooting and problem solving to help identify root causes for production problems, and to find potential solutions. The issues are sometimes associated with the product itself, such as microbial contamination or the presence of particulates, or there may be process-related challenges, which can include equipment failures and utilities not meeting established specifications. It is beneficial to track and analyze product and facility data via quality metrics to determine root causes of problems, and several organizations have taken such an approach. Just as importantly, a fundamental understanding of the processes and operations used to manufacture injectables is needed. Production facilities, as well as the processes by which injectable products are manufactured, should be evaluated from an engineering perspective, such that operations can be critically assessed. For example: Where in the process are the inefficiencies? What are the opportunities to improve key steps in the process and how can they be implemented? What equipment upgrades and novel technologies will be economically beneficial in the long run? Lastly, the importance of corporate culture and employee education will be discussed, as these factors play major roles in producing high quality pharmaceutical products.
Lori Herz, Ph.D. is currently a Professor of Practice of Chemical Engineering at Lehigh University. She is the Associate Director of the Bioengineering Program at Lehigh, where she teaches the Metabolic Engineering and Biotechnology Laboratory courses. Additionally, she is affiliated with the Integrated Product Development program, for which she has advised student teams working on their capstone design projects.
Prior to joining Lehigh, Dr. Herz worked at Bristol-Myers Squibb Company for nine years. She started in Technical Operations, supporting technology transfer and the manufacture of sterile liquid and lyophilized drug products. She later managed early-phase clinical operations and process scale-up of protein therapeutics. In addition to her position at Lehigh, Dr. Herz is the owner of Herz Biotechnology Consulting, which she started in 2011.
She received her B.S. in Chemical Engineering from Cornell University and her Ph.D. in Chemical and Biochemical Engineering from Rutgers, the State University of New Jersey. She is currently the faculty adviser for the Lehigh chapter of Alpha Omega Epsilon, as well as a member of AICHE and the Society for Biological Engineering.