Biomedical Engineering Reference
In-Depth Information
REFERENCES
[1] Juran JM. Juran on Quality by Design. The New Steps for Planning Quality into Goods and
Services. New York: Simon and Schuster; 1992.
[2] ICHQ6A. Specifications: Test Procedures andAcceptance Criteria for NewDrug Substances
and New Drug Products: Chemical Substances. 2000. Available at www.ich.org.
[3] ICH Q5A. Viral Safety Evaluation of Biotechnology Product Derived from Cell Lines of
Human or Animal Origin. 1997. Available at www.ich.org.
[4] Korneyeva M, Rosenthal S, Charles P, Trejo S, Pifat D, Petteway S. Important parameters
for optimal target virus clearance: virus spike issues. Am Pharm Rev 2004;7(1):38-42.
[5] Kasermann F, Kempf C, Boschetti N. Strengths and limitations of the model virus concept.
PDA J Pharm Sci Technol 2004;58(5):244-249.
[6] Valera CR, Chen JW, Xu Y. Application of multivirus spike approach for viral clearance
evaluation. Biotechnol Bioeng 2002;80(3):257-267.
[7] PDA Letter. October, Bethesda, MD, 2007.
[8] ICH Q9. Quality Risk Management. Available at www.ich.org. 2005.
[9] Middleton PG, Miller S, Ross JA, Steel CM, GuyK. Insertion of SMRV_H viral DNA at the
c-myc gene locus of a BL cell line and presence in established cell lines.
Int J Cancer
2002;52:451-454.
[10] Garnick RL. Rawmaterials as a source of contamination in large-scale cell culture. Dev Biol
Stand 1998;93: 21-29.
[11] Kreil TR, Berting A, Kistner O, Kindermann J. West Nile virus and the safety of plasma
derivatives: verification of high safety margins, and the validity of predictions based on
model virus data. Transfusion 2003;43:1023-1028.
[12] U.S. Food and Drug Administration. http://www.fda.gov.
[13] EMEA. http://www.emea.europa.eu/htms/human/epar/eparintro.htm.
[14] Sofer G, Lister DC, Boose JA. Part 6, inactivation methods grouped by virus. BioPharm Int
2003; (Suppl.):S-37-S-42.
[15] PDA Task Force on Virus Spike Standardization. Technical Report. In progress.
[16] Brorson K, Brown J, Hamilton E, Stein KE. Identification of protein Amedia performance
attributes that can bemonitored as surrogates for retrovirus clearance during extended re-use.
J Chromatogr A 2003;989:155-163.
[17] Norling L. Impact of multiple re-use of anion exchange chromatography media on virus
removal. J Chromatogr A 2005;1069:79-89.
[18] U.S. Food and DrugAdministration. 1997. Points toConsider in theManufacture and Testing
ofMonoclonal Antibody Products for HumanUse. Bethesda,MD. Available at www.fda.gov.
[19] Curtis S. Generic/matrix evaluation of X-MuLV and SV40 clearance by anion exchange
chromatography in flow-through mode. Oral Presentation at IBC's 8th International
Conference on Process Validation for Biologicals, March 7-8, San Diego, CA; 2005.
[20] Parenteral Drug Association. PDATechnical Report No. 41: Revised 2008 Virus Filtration.
PDA J Pharm Sci Technol 2008;62(5-4). Available at www.pda.org.
[21] CHMP Draft Guideline on Production and Quality Control of Monoclonal Antibodies and
Related Substances. EMEA/CHMP/BWP/157653/2007. Available at www.emea.europa.eu.
[22] Sofer G, Jagschies G. Economy by design for biopharmaceutical chromatographic
processes. Pharm Tech Europe 2007;19(12):36-40.
Search WWH ::




Custom Search