A Novel Process for Developing Fully Human Monoclonal Antibodies - Pharmaceutical Technology

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A Novel Process for Developing Fully Human Monoclonal Antibodies
The authors describe a process for generating high affinity, fully human antibodies in culture. Specially selected splenocytes are incubated with cytokines and low levels of antigen, yielding affinity-matured, class-switched B cells. The fully human, specific antibodies produced by these cells can then be cloned and expressed for further characterization.

Pharmaceutical Technology
pp. s28-s31


This work was supported in part by the National Cancer Institute of the National Institutes of Health under award number R43CA126070 and R43CA128752. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Brian Schram, PhD, is a senior scientist, Matt Howard is a research scientist, Marjorie Curet is a senior scientist, and Rachel Kravitz, PhD, is director of research, all at Neoclone, Madison WI. Voula Kodoyianni, PhD*, is a product manager at Thermo Fisher Scientific, Madison, WI. *


1. Datamonitor Pipeline Insight, "Biologic Targeted Cancer Therapies, Next Generation Jostles for Market Position," DMHC2573. (2009).

2. G. Kohler and C. Milstein, Nature 256, 495–497 (1975).

3. R. Fagnani, Immunol Ser 61, 3–22 (1994).

4. R. Fagnani, S. Halpern, and M. Hagan, Nucl. Med. Commun. 16, 362–369 (1995).

5. M. B. Khazaeli, R. M. Conry, and A. F. LoBuglio, J. Immunother. Emphasis Tumor Immunol. 15, 42–52 (1994).

6. P. Mitchell, Nat. Biotechnol. 23, 906 (2005).

7. M. C. Via, "Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment," (Insight Pharma Reports, 2010).

8. N. R. Gonzales et al., Mol. Immunol. 41, 863–872 (2004).

9. S. V. Kashmiri et al., Methods 36, 25–34 (2005).

10. J. Osbourn, M. Groves, and T. Vaughan, Methods 36, 61–68 (2005).

11. D. M. Fishwild et al., Nat. Biotechnol. 14, 845–851 (1996).

12. L. L. Green, J. Immunol. Methods 231, 11–23 (1999).

13. L. L. Green et al., Nat. Genet. 7, 13–21 (1994).


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