Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer Vaccine - By incorporating disposable technologies and an improved purification scheme, scale-up and validation problems w

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Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer Vaccine
By incorporating disposable technologies and an improved purification scheme, scale-up and validation problems were resolved.


BioPharm International Supplements


References

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2. Rosenberg S. Progress in human tumor immunobiology and immunotherapy. Nature. 2001;411:380–384.

3. Lage A, Crombet T, González G. Targeting epidermal growth factor receptor signaling: Early results and future trends in oncology. Annal Med. 2003;35:327–336.

4. Fukuoka M, Yano S, Giaccone G, Tamura T, Nakagawa K, Douillard JK. Final results from a phase II trial of ZD 1839. ("Iressa") for patients with advanced non-small-cell lung cancer (IDEAL 1). Proc Am Soc Clin Oncol. 2002;21:292a Abs1188.

5. Mateo C, Moreno E, Amour K, Lombardero J, Harri W, Perez R. Humanization of a mouse monoclonal antibody that block the EGF-R: recovery of antagonistic activity. Immunotechnology. 1997;3:71–81.

6. Slamon DJ, Leyland-Jones B, Fuchs H, Platon V. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast that overexpresses Her2. N Engl J Med. 2001;344:783–792.

7. Lage A, Pérez R, Fernández L.E. Therapeutic cancer vaccines—At midway between immunology and pharmacology. Curr Cancer Drug Targets. 2005;5:611–627.

8. Yu Z, Restifo NP. Cancer vaccines: Progress reveals new complexities. J Clin Invest. 2002;110:289–294.

9. Patent EP 0 657 175 B1 and US 5 894 018: Vaccine comprising human autologous epidermal growth factor and use thereof.

10. González G, Sánchez B, Suárez, E, Beausoleil, I, Perez, O, Lastre, M, Lage, A. Induction of immune recognition of self epidermal growth factor (EGF): Effect on EGF biodistribution and tumor growth. Vaccine Res.1996;5(4):233–244.

11. González G, Pardo O.L, Sánchez B, García JL, Beausoleil I, Marinello P, González Y, Domarco A, Guillén G, Pérez R., Lage A. : induction of immune recognition of self epidermal growth factor II: Characterization of the antibody response and use of a fusion protein. Vaccine Res. 1997;6(4):91–100.

12. González G, Crombet T, Catalá M, Mirabal V, Hérnandez J.C, González Y, Marinello P, Guillén G, Lage A. A novel cancer vaccine composed of human recombinant epidermal growth factor linked to a carrier protein: Report of a pilot clinical trial. Ann Onc. 1996;9:431–435.

13. González G, Crombet T, Torrea F, Catalá M, Alfonso L, Osorio M, Neninger E, García B, Mulet A, Pérez R, Lage A. Epidermal growth factor-based cancer vaccine for non-small-cell lung cancer therapy. Ann Onc. 2003;14:461–466.

14. Crombet T, Neninger E, Catalá M, Garcia B, Leonard I, Gonzalez G, Perez R, Lage A. Treatment of NSCLC patients with an EGF-based cancer vaccine: Report of a phase I trial. Cancer Biol Ther. 2006;5(2):145–149.

15. González G, Lage A. Cancer vaccines for hormone immune deprivation: The EGF vaccine approach. Leading Top Cancer Vacc. 2007; Chapter 11, Ed NOVA Publishers.

16. González G, Lage A. Cancer vaccines for hormone/growth factor immune deprivation: A feasible approach for cancer treatment. Curr Cancer Drug Targets. 2007;7(3):191–201.

17. González G, Crombet T, Neninger E, Viada C, Lage A. Therapeutic vaccination with epidermal growth factor/EGF) in advanced lung cancer: Analysis of pooled data from three clinical trials. Human Vacc. 2007;3(1):8–13.

18. García B, Neninger E, De la Torre A, Leonard I, Martínez R, Viada C, González G, Mazorra Z, Lage A, Crombet T. Effective inhibition of the epidermal growth factor / epidermal growth factor receptor binding by anti-epidermal growth factor antibodies is related to better survival in advanced non-small-cell lung cancer patients treated with the epidermal growth factor cancer vaccine. Clin Cancer Res. 2008;14(3):840–846.

19. Neninger E, De la Torre A, Osorio M, Catalá M, Bravo I, Mendoza M, Abreu D, Acosta S, Rives R, Carrillo C, González M, Viada C, García B, Crombet T, González G, Lage A. Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell-lung cancer. J Clin Onc. 2008;26(9):1452–1458.


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