by Todd L. Talarico, Kevin Williams, Timothy Yeh, Bruno Pancorbo, Mélanie Bérubé, Michael Murphy, and Michèle Dargis
Volume 16, Issue 1 (Spring 2017)
Biologics are often produced in or derived from matrices that harbor the potential for introduction of adventitious agents to the drug product. This potential is not strictly theoretical, as viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), porcine circovirus (PCV), and minute virus of mice (MVM) have been detected in biological products in the past. From a regulatory and safety perspective, assurance that adventitious agents are not present in the drug product is a critical measure of product quality. Guidelines for assuring safety, with respect to adventitious agents in blood-derived products and products produced in mammalian cell culture, are addressed in specific guidances from the Food and Drug Administration (FDA) and the Committee for Proprietary Medicinal Products (CPMP). These guidance documents suggest that safety is best assured through screening donor material or production cell lines, by controlling animal-derived raw materials used during manufacture, incorporating viral removal and inactivation steps in the production process, and protecting the product from the environment during manufacture. Even though Medicago develops products that are produced in plants, a host that does not support the replication of viruses that infect mammals, various regulatory agencies have advised that the production process should contain one or more operations that remove or inactivate adventitious agents. Medicago has investigated multiple methodologies to accomplish this goal, and has found ultraviolet C (UVC) irradiation treatment to be effective for adventitious agent inactivation in the production process used to manufacture their quadrivalent influenza vaccine without detrimental impact to the product…
Citation:
Talarico TL, Williams K, Yeh T, Pancorbo B, Bérubé M, Murphy M, Dargis M. Inactivation of adventitious agents by UVC irradiation in a plant-based influenza vaccine production process. BioProcess J, 2017; 16(1): 15–24. https://doi.org/10.12665/J161.Talarico
Posted online May 8, 2017.