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Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin
Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin and Hamdallah H. Zedan
PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 499-510; DOI: https://doi.org/10.5731/pdajpst.2015.01058
Norhan S. Sheraba
1Vacsera, The Holding Company for Biological Products and Vaccines, Giza, Egypt;
Mohamed R. Diab
1Vacsera, The Holding Company for Biological Products and Vaccines, Giza, Egypt;
Aymen S. Yassin
2Department of Microbiology and Immunology, Faculty of Pharmacy, Cairo University, Cairo, Egypt
Magdy A. Amin
2Department of Microbiology and Immunology, Faculty of Pharmacy, Cairo University, Cairo, Egypt
Hamdallah H. Zedan
2Department of Microbiology and Immunology, Faculty of Pharmacy, Cairo University, Cairo, Egypt

References
- 1.↵
- 2.↵
- Acconci C.,
- Legallais C.,
- Vijayalakshmi M.,
- Bueno S. M.
- 3.↵
- Santos P. G.,
- Santos D. O.,
- Serodio L. R.,
- Marinho R. D. S.,
- Rodrigues C. R.,
- Cabral L. M.,
- de Pádula M.,
- de Sousa V. P.,
- Castro H. C.
- 4.↵British Pharmacopoeia; Her Majesty's Stationary Office: London, 2008; pp 3500–3501.
- 5.↵
- Bashar T.,
- Shurovi K. M.,
- Dilshad S.
- 6.↵
- Morey P. R.,
- Feeley J. C.,
- Otten J. A.
- Olenchock S. A.
- 7.↵
- 8.↵
- Laitinen S.,
- Nevalainen A.,
- Kotimaa M.,
- Liesivuori J.,
- Martikainen P. J.
- 9.↵World Health Organization (WHO). Guidelines for the Production, Control and Regulation of Snake Antivenom Immunoglobulins. Blood Products and Related Biologicals, WHO, 58th Meeting, Geneva, Switzerland, 2008.
- 10.↵
- Utescher C. L. A.,
- Franzolin M. R,
- Trabulsi L. R.,
- Gambale V.
- 11.↵
- Denyer S. P.,
- Baird R. M.
- 12.↵
- Langer U.,
- Krämer I.
- 13.↵
- Vincent D. W.
- 14.↵
- 15.↵
- Benson H. J.
- 16.↵United States Pharmacopeia 32-NF27. Chapter <71> Sterility Tests. In The United States Pharmacopeia 31st ed.—National Formulary 26th ed.; United States Pharmacopeia Convention, Inc.: Rockville, MD, 2009; pp 85–91.
- 17.↵
- Akers M. J.,
- Larrimore D. S.
- 18.↵
- Cooper J. F.,
- Hung J. C.
- 19.↵
- 20.↵
- Dawson M. E.
- 21.↵
- 22.↵
- Szymanska J.
- 23.↵
- Coccia A. N.,
- Gucci P. M.,
- Lacchetti I.,
- Paradiso R.,
- Scaini F.
- 24.↵
- Perdelli F.,
- Dallera M.,
- Cristina M. L.,
- Sartini M.,
- Ottria G.,
- Spagnolo A. M.,
- Orlando P.
- 25.↵European Commission. The Rules Governing Medicinal Products in the European Union. EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Vol 4. Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma. European Commission: Brussels, 2010.
- 26.↵
- Singh T. S.,
- Bello B.,
- Mabe O. D.,
- Renton K.,
- Jeebhay M. F.
- 27.↵
- 28.↵
- Krieg N. R.,
- Holt J. G.
- 29.↵
- Halls N.
- Halls N.
- 30.↵
- 31.↵
- Clontz L.
- 32.↵
- Evans T. M.,
- Schillinger J. E.,
- Stuart D. G.
- 33.↵
- Rylander R.
- 34.↵
- Stellman J. M.,
- Klitzman S.,
- Gordon G. C.,
- Snow B. R.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 4
July/August 2015
Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin
Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin, Hamdallah H. Zedan
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 499-510; DOI: 10.5731/pdajpst.2015.01058
Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin
Norhan S. Sheraba, Mohamed R. Diab, Aymen S. Yassin, Magdy A. Amin, Hamdallah H. Zedan
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 499-510; DOI: 10.5731/pdajpst.2015.01058
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