GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological Reagent - - BioPharm International

ADVERTISEMENT

GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological Reagent

The positive results obtained during inspections carried out by our regulatory entity, Center for State Control of Drug Quality (CECMED), and the recent WHO inspection demonstrate that we have achieved a product of quality that fulfills the GMP. By keeping in mind all these requirements and by applying GMPs we have achieved the manufacture of a quality antibody for human use.

Biunayki Reyes Díaz, BSc.,and his colleagues listed, participated in the completion of this article and the work that supports it. Mr.Reyes Díaz, is the corresponding author.He and his colleagues currently work at: Monoclonal Antibody Division, Development Biotechnological Unit, Center for Genetic Engineering and Biotechnology Ave.31 e/ 158 y 190,Playa Cubanacan P.O.Box 6162, Havana 10600, Cuba Fax: 53.7.271.3208;

This article first appeared in J. GXP Compliance, Vol.9, No.3 (2005), pp 52-61.

REFERENCES

1. Good Manufacturing Practices for Biological Products, World Health Organization, WHO Technical Report Series, No. 822, 1992.

2. Darling A. J. and Spaltro J. J., "Process Validation for Virus Removal. Considerations for Design of Process Studies and Viral Assays," Biopharm, Vol. 9, No. 9, 1996 pp: 42-50.

3. Kohler G., Milstein C., "Continuous Cultures of Fused Cells Secreting Antibodies of Predefined Specificity," Nature, 256: 495-497, 1975.

4. Plucktun A., "Mono-and Bivalent Antibody Fragments Produced in Escherichia Coli: Engineering, Folding and Antigen Binding," Immunological Reviews, 130:150-188, 1992.

5. Yilma. T., Ristow. S., Moss B., and Jones. L., "A Novel Approach for the Production of Monoclonal Antibodies Using Infectious Vaccinia Virus Recombinants," Hybridoma Aug, 6 (4): 329-35, 1987.

6. Richard R., Woodward S., "Ethical Considerations in the Testing of Biopharmaceutical for Adventitious Agents," Science and Engineering Ethics 3, 1995.

7. Matson S.R., Little C.M.J., "Strategy for the Immobilization of Monoclonal Antibodies on Solid-phase Supports," J. Chromatography, 458: 67-77, 1988

8. Cosme K., "Producción de Anticuerpos Monoclonales por el Método de Ascitis en la Cepa Endogámica BALB/c y Ratones Híbridos F1," Animales de experimentación. Revista hispanoamericana, 4:13-15, 1999.

9. Danielson A., Ljunglof A., and Lindblom H., "One Step Purification of Monoclonal IgG Antibodies from Mouse Ascites," J. Immunol. Methods, 115:79-88, 1988.

10. Valdés R., Ibarra N, Ruibal I., Beldarraín A., Noa E., Herrera N., Alemán R., Padilla S., Garcia J., Pérez M., Morales R., Chong E., Reyes B., Quiñones Y., Agraz A., Herrera L., "Chromatography Removal Combined with Heat, Acid and Chaotropic Inactivation of Four Model Viruses," Journal of Biotechnology, Jul 2002, 96: 251-258,.

11. Aleman M.R., Gonzalez M., Mendoza O., Pérez M., Reyes B., Ibarra N., and Valdés R., "Hepatitis B Monoclonal Antibody. Master Cell Bank," Biopharm, 13 no. 6 (June): 48-52, 2000.

12. Vasilevsky M. and Cherry C.W, "Documentation Requirements in the Biotechnology Industry," Biopharm, 3 No. 9 (October): 32-35, 1990.

13. Carol DeSain, "Standard Operating Procedures and Data Collection Forms," Biopharm, 4 No. 10 (October): 23-29, 1991.

14. Valdés R., Diaz T., Nieto A., Garcia C., Pérez M., Garcia J., Quiñones Y., "Sendai Virus Removal and Inactivating During Monoclonal Antibody Purification," Biotecnol Aplic. 12, 15-20, 1995.

14. Valdés R., Diaz T., Nieto A., Garcia C., Pérez M., Garcia J., Quiñones Y., "Sendai Virus Removal and Inactivating During Monoclonal Antibody Purification," Biotecnol Aplic. 12, 15-20, 1995.

15. Terman S., Bertram J.H., "Anti-tumor Effects of Immobilized Protein A and Staphylococcal Products: Linkage between Toxicity and Efficacy, and Identification of Potential Tumoricidal Reagents," Eur. J. Cancer Clin. Onco, 21, 1115-1118, 1985.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Pfizer to Acquire Vaccines from Baxter
July 30, 2014
GSK Submits EU Regulatory Filing for Malaria Vaccine Candidate
July 29, 2014
Bristol-Myers Squibb and Ono Pharmaceutical Collaborate on Immunotherapies
July 28, 2014
FDA Accepts First Biosimilar Filing
July 24, 2014
Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
Author Guidelines
Source: BioPharm International,
Click here