Description

Successful manufacturing cell line development is based on the application of advanced molecular genetic and cell biology concepts combined with sophisticated instrumentation within a highly regulated environment. The objective of the course is to provide up-to-date information on every aspect of mammalian cell line development. The course will introduce the scientific background of mammalian cell physiology, protein expression and post-translational modification relevant to industrial protein production. We'll cover the characteristics of the different industrially significant mammalian host cell types and the cell engineering approaches improving the performance of the host as well as targeting the drug substance attributes. Theoretical and practical information will be given on steps in different cell line development workflows. Various analytical methods supporting cell line generation, cell line and cell bank characterization will be presented. The relevant regulatory guidelines and the contents of cell substrate related CMC sections will also be discussed.

Instructor

Ferenc Boldog Ph.D., Associate Director of Cell Line Development, Shire Human Genetic Therapies
Ferenc Boldog received his Ph.D. in Cell Biology from The University of Lorand Eotvos in Hungary. Following postdoc years, working on the fields of regulation of mammalian cell proliferation and human tumor biology, in Hungary and at the Karolinska Institute in Sweden, he continued his academic career, in the University of Colorado, focusing on positional cloning of disease associated genomic loci and generating physical maps of human chromosome 3. Later, he joined CuraGen Corporation and was responsible for identifying, and cloning novel human genes and expressing the relevant proteins using various protein expression platforms including mammalian stable cell lines. Currently he is responsible for the clinical/commercial manufacturing cell line development and cell banking functions at Shire. Ferenc has coauthored 38 peer reviewed publications and seven issued patents.

Course Agenda

• Cellular and molecular biology foundation of mammalian cell physiology, protein synthesis and recombinant protein expression
• Towards high producer cell lines—placing theory into practice for recombinant protein expression in mammalian cells
  • Industrially relevant host cell characteristics
  • Cell engineering—towards improved hosts and more potent biologics
  • Elements of expression vector design
  • Cell culture media
• Cell line generation workflows
  • Pros and cons of the various available approaches
  • Steps in the processes
  • Timelines
  • In process analytical requirements
  • Instrumentation
  • Raw material qualification
• Cryopreservation, cell banking systems
• Cell line, cell bank characterization
• Regulatory guidelines
• Cell substrate related CMC sections