Bench-Scale Characterization of Cleaning Process Design Space for Biopharmaceuticals - A method to evaluate the relative cleanability of new products. - BioPharm International

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Bench-Scale Characterization of Cleaning Process Design Space for Biopharmaceuticals
A method to evaluate the relative cleanability of new products.


BioPharm International
Volume 22, Issue 3

REFERENCES

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3. US Food and Administration. Current good manufacturing practice for finished pharmaceuticals. Code for Federal Regulations. 2004, Title 21, Volume 4, Section 211.67. Washington DC: US Government Printing office.

4. Mollah AH. Cleaning Validation for Biopharmaceutical Manufacturing at Genentech. BioPharm Int. 2008 Mar;21(3):68–75.

5. Sanchez JAM. Equipment cleaning validation within a multi-product manufacturing facility. BioPharm Int. 2006 Feb;19(2):38–49.

6. Rathore N, Qi W, Ji W. Cleaning characterization of protein drug products using UV-vis spectroscopy. Biotechnol Prog. 2008;24(3):684–690.

7. Mollah AH, White EK. Risk-based cleaning validation in biopharmaceutical API manufacturing. BioPharm Intl. 2005 Nov;18(11):54–67.

8. Sharnez R, Lathia, J, Kahlenberg D, Prabhu S. In situ monitoring of soil dissolution dynamics: A rapid and simple method for determining worst-case soils for cleaning validation. PDA J Pharm Sci Technol. 2004;58:203–214.

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11. Verghese G. Selection of Cleaning Agents and Parameters for cGMP Processes. Proceedings of the Interphex Conference; 1998 Mar 17–19, Philadelphia, PA.

12. LeBlanc DA. Visually clean as the sole acceptance criteria for cleaning validation protocols. PDA J Pharm Sci Technol. 2002;56:31–36.

13. Forsyth RJ, Nostrand VV. Using visible residual limits for introducing new compounds into a pharmaceutical research facility. Pharm Technol. 2005;29(4):134–140.

14. Forsyth RJ, Roberts J, Lukievics T, Nostrand VV. Correlation of visible-residue limits with swab results for cleaning validation. Pharm Technol. 2006.

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16. JMP Statistical Discovery from SAS, Release 6, SAS Institute Inc, 2006.

17. Sheen SJ, Sheen VL. Characteristics of Fraction-1-protein Degradation by Chemical and Enzymatic Treatments. J Agric Food Chem. 1987;35:948–952.

18. Martinez JE. Immunogenic Potential of Therapeutic Protein Residues after Cleaning. Bioprocess Int. 2004;2(9):38–44.


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