Pharmaceutical Technology - 6

Pharmaceutical Technology and BioPharm eBook - Vaccine 2017

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Pharmaceutical Technology VACCINE DEVELOPMENT AND MANUFACTURING 2017 11 Manufacturing E stablished vaccine manufacturing technologies, whether for viral, microbial, recombinant protein, or polysaccha- ride vaccines, are complex, often highly customized, and typically performed in dedicated facilities. Development and approval times are therefore lengthy, and the entire process is costly. Rapid response to pandemic diseases and implementation of vaccine manufacturing in developing economies is a challenge. Standardization, or the use of vaccine manufacturing platforms that can be deployed across different vaccines and vaccine types, could ameliorate this situation. Limitations of existing vaccine technologies Unlike biologic drugs based on recombinant proteins, the biologi- cal compounds used in most vaccines are not fully chemically and physically characterizable using existing analytical methods, says Thomas Lingelbach, CEO of Valneva. ÒAs a result, the manufactur- ing process itself is part of the licensure and must be fully established before a vaccine producer can seek regulatory approval,Ó he observes. In addition, some delays to clinical study starts can be attributed to aspects of the product development cycle, such as long lead times to develop a product-specific cell line, process improvements for en- hanced yield and purity, formulation studies for improved stability, and analytical method development for release and product charac- terization, according to Tim Hahn, senior vice-president for global manufacturing operations with Novavax. The manufacture of vaccines in large-scale, stainless-steel facilities also has its limits. ÒThe construction and validation of very complex facilities increases the time-to-market schedule and the environ- Accelerating Vaccine Development and Manufacturing Cynthia Challener The use of approved platform technologies can reduce the time and cost required to generate new vaccines. Cynthia Challener is a contributing editor to Pharmaceutical Technology and BioPharm International. KISELEV ANDREY VALEREVICH/SHUTTERSTOCK.COM

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