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

1. International Conference on Harmonization (ICH). Annex to Q8. Pharmaceutical Development. Version 2. 2007 Nov 1.

2. Rathore N, Rajan R. Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol Prog. 2008;24(3):504–514.

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.

9. Le Blanc DA. Validated cleaning technologies for pharmaceutical manufacturing. Boca Raton, FL:, CRC Press LLC; 2000.

10. Cardot J-M, Beyssac E. The basics of cleaning and cleaning validation. Bioprocess Int. 2007;5(6):66–76.

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.

15. Forsyth RJ, Nostrand VV, Martin GP. Visible-residue limits for cleaning validation and its potential application in a pharmaceutical research facility. Pharm Technol. 2004;28(10):58–72.

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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