title: Implementing high-temperature short-time media treatment in commercial-scale cell culture manufacturing processes.
abstract: The production of therapeutic proteins by mammalian cell culture is complex and sets high requirements for process, facility, and equipment design, as well as rigorous regulatory and quality standards. One particular point of concern and significant risk to supply chain is the susceptibility to contamination such as bacteria, fungi, mycoplasma, and viruses. Several technologies have been developed to create barriers for these agents to enter the process, e.g. filtration, UV inactivation, and temperature inactivation. However, if not implemented during development of the manufacturing process, these types of process changes can have significant impact on process performance if not managed appropriately. This article describes the implementation of the high-temperature short-time (HTST) treatment of cell culture media as an additional safety barrier against adventitious agents during the transfer of a large-scale commercial cell culture manufacturing process. The necessary steps and experiments, as well as subsequent results during qualification runs and routine manufacturing, are shown.
authors.affiliation: Manufacturing Operations, Genentech, Inc., 1 Antibody Way, Oceanside, CA, 92056, USA, pohlscheidt.michael@gene.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Pohlscheidt
authors.forename: Salim
authors.initials: S
authors.lastname: Charaniya
authors.forename: Fikret
authors.initials: F
authors.lastname: Kulenovic
authors.forename: Mahalia
authors.initials: M
authors.lastname: Corrales
authors.forename: Masaru
authors.initials: M
authors.lastname: Shiratori
authors.forename: Justin
authors.initials: J
authors.lastname: Bourret
authors.forename: Steven
authors.initials: S
authors.lastname: Meier
authors.forename: Eric
authors.initials: E
authors.lastname: Fallon
authors.forename: Robert
authors.initials: R
authors.lastname: Kiss
mesh_terms: D018929:Cell Culture Techniques; D003470:Culture Media / Q000528:radiation effects*; D004203:Disinfection / Q000379:methods*; D006358:Hot Temperature; D013997:Time Factors
chemical_list: D003470:Culture Media