Development of A Platform Process for the Purification of Therapeutic Monoclonal Antibodies

Process Scale Purification of Antibodies

Volumn , Issue , 2008, Pages 187-201

  Li, Yuling ^a   Kahn, David W ^a   Galperina, Olga ^a   Blatter, Erich ^a   Luo, Robert ^a   Wu, Yaling ^a   Zhang, Guihang ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Chromatography steps in platform process; Developing viral clearance database; Platform process development

Indexed keywords

EID: 80053457078     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470444894.ch9     Document Type: Chapter

References (9)

1. Li, Y. (2006). The HGS process development and platform strategies for monoclonal antibody purification, not quite one size fits all. IBC' s 16th Antibody Production and Downstream Processing conference, Carlsbad, CA, 2006.
2. Van Loghem, E., Frangione, B., Recht, B., Franklin, E.C. (1982). Staphylococcal protein A and human IgG subclasses and allotypes. Scandinavian Journal of Immunology 15, 275-278.
3. Shadel, P.J., Erickson, J.C., Scott, R.G., Smith, T.M. (1994). Antibody purification. US Patent #5429746.
4. Luo, R.G., Waghmare, R., Krishnan, M., Adams, C., Kahn, D. (2006). High - concentration UF/DF of a monoclonal antibody-Strategy for optimization and scale-up. BioProcess International 4, 44-48.
5. Arunakumari, A. (2007). Downstream design considerations for efficient batch processing of high titer cell culture processes for the production of human monoclonal antibodies. Presentation at the BioProcess International European Conference and Exhibition, Paris, France, 2007.
6. Newcombe, A.R., Cresswell, S.D., Watson, K., Harris, G., O' Donovan, K., Francis, R. (2005). Optimised affinity purification of polyclonal antibodies from hyper immunised ovine serum using a synthetic Protein A adsorbent, MAbsorbent ®; A2P. Journal of Chromatography B 814, 209-215.
7. Arunakumari, A., Wang, J., Ferreira, G. (2007). Alternatives to Protein A: Improved downstream process design for human monoclonal antibody production. BioProcess International 20 (suppl.), 36-40.
8. Li, Y., Galperina, O. (2005). HGS' in-house concept for virus safety evaluation of biotech products in clinical development. Presentation at the PDA Viral Safety Conference for Clinical Products, Langen, Germany, 2005.
9. Galperina, O., Li, Y. (2007). Virus safety evaluation using a platform purification process. Presentation at IBC' s 18th International Antibody Development & Production Conference, Carlsbad, CA, 2007