Characterization of a non-originator NISTmAb expression system
May 6-11, 2018
The successful development and regulatory approval of originator and biosimilar therapeutic proteins requires system approach to upstream and downstream processing as well as product characterization and quality control. Innovation in process design and control, product characterization strategies, and data integration represent an ecosystem whose concerted advancement may reduce time-to-market and further improve comparability and biosimilarity programs. The NISTmAb, an IgG1k antibody generated against Respiratory Syncytial Virus (RSV), serves as a representative therapeutic like molecule for technology development with respect to production, purification and analytical characterization of the product. Three, non-originator cell lines expressing the NISTmAb were constructed to enable the development of downstream and upstream process. The products of the three cell lines and their similarities and differences from the NISTmAb will be presented.
Lila Kashi, "Characterization of a non-originator NISTmAb expression system" in "Cell Culture Engineering XVI", A. Robinson, PhD, Tulane University R. Venkat, PhD, MedImmune E. Schaefer, ScD, J&J Janssen Eds, ECI Symposium Series, (2018). http://dc.engconfintl.org/ccexvi/17