Analytical Tools for Process and Product Characterization - Select the best approach to determine critical quality attributes. - BioPharm International

ADVERTISEMENT

Analytical Tools for Process and Product Characterization
Select the best approach to determine critical quality attributes.


BioPharm International
Volume 22, Issue 8

REFERENCES

1. Rathore AS, Winkle H. Quality by Design for pharmaceuticals: regulatory perspective and approach. Nature Biotechnol. 2009;27:26–34.

2. Rathore AS, Branning R, Cecchini D. Design space for biotech products. BioPharm Int. 2007;20(4):36–40.

3. Kozlowski S, Swann P. Considerations for biotechnology product Quality by Design. Rathore AS, Mhatre R, editors. In Quality by Design for biopharmaceuticals: Perspectives and case studies. New Jersey: Wiley Interscience; 2009. p. 9–30.

4. Swann PG, Tolnay M, Muthukkumar S, Shapiro MA, Rellahan BL, Clouse KA. Considerations for the development of therapeutic monoclonal antibodies. Curr Opin Immunol. 2008;(42):493–99.

5. Towns J, Webber K. Demonstrating comparability for well-characterized biotechnology products. BioProcess Int. 2008;2:32–43.

6. Schnerman MA, Sunday BR, Kozlowski S, Webber K, Gazzano-Santoro H, Mire-Sluis A. CMC strategy forum report: analysis and structure characterization of monoclonal antibodies. BioProcess Int. 2004;(2):42–52.

7. International Conference on Harmonization. Q6B, Specifications: test procedures and acceptance criteria for biotechnological/biological products. Geneva, Switzerland; 1999.

8. Krull IS, Swartz M. Validation in biotechnology and well-characterized biopharmaceutical product. Pharmaceutical Regulatory Guidance Book. 2006;7:18–23.

9. Apostol I, Kelner D. Managing the analytical lifecycle for biotechnology products. BioProcess Int. Part 1: 2008;9:12–19. Part 2: 2008;(10):12–19.

10. Wu J, Watson JT. Assignment of disulfide bonds in proteins by chemical cleavage and peptide mapping by mass spectrometry. Methods Mol Biol. 2002;194:1–22.

11. Yen T-Y, Yan H, Macher BA. Characterizing closely-spaced, complex disulfide bond patterns in peptides and proteins by liquid chromatography/electrospray ionization tandem mass spectrometry. J Mass Spectrom. 2002;37:15–30.

12. Martinez T, Guo A, Allen MJ, Han M, Pace D, Jones J, et al. Disulfide connectivity of human immunoglobulin G2 structural isoforms. Biochem. 2008;47:7496–508.

13. Zhang W, Marzilli LA, Rouse JC, Czupryn MJ. Complete disulfide bond assignment of a recombinant immunoglobulin G4 monoclonal antibody. Anal Biochem. 2002;311:1–9.

14. Wypych J, Li M, Guo A, Zhang Z, Martinez T, Allen MJ, et al. Human IgG2 antibodies display disulfide-mediated structural isoforms. J Biol Chem. 2008;283:16194–205.

15. Cockrill SL. Complete determination of IgG2 disulfide connectivity: defining an analytical strategy for a new structural paradigm. Invited talk. IBC 12th Annual Well Characterized Biologicals Conference; 2008 Nov 10–12; Reston, VA.

16. European Commission (Enterprise Directorate General). EMEA Guideline on Production and Quality Control of Monoclonal Antibodies and Related Substances (Draft). Brussels, Belgium; 2008 Jul. Available from http://www.emea.europa.eu/pdfs/human/bwp/15765307en.pdf.

17. Anumula KR. High-sensitivity and high resolution methods for glycoprotein analysis. Anal Biochem. 2000;283:17–26.

18. Chen X, Flynn GC, Analysis of N-glycans from recombinant immunoglobulin G by on-line reversed-phase high-performance liquid chromatography/mass spectrometry. Anal Biochem. 2007;370:147–61.

19. Prater BD, Anumula KR, Hutchins JT, Automated sample preparation facilitated by PhyNexus MEA purification system for oligosaccharide mapping of glycoproteins. Anal Biochem. 2007;369:202–09.

20. Prater BD, Connelly HM, Qin Q, Cockrill SL. High-throughput immunoglobulin G N-glycan characterization using rapid resolution reverse-phase chromatography tandem mass spectrometry. Anal Biochem. 2009;385:69–79.

21. Nguyen LT, Wiencek JM, Kirsch LE. Characterization methods for the physical stability of biopharmaceuticals. PDA J Pharm Sci Technol. 2003;57:429–45.

22. Gabrielson JP, et al. Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity. J Pharm Sci. 2007;96(2):268–79.

23. Philo JS. Is any measurement method optimal for all aggregate sizes and types? AAPS J. 2006;8(3):E564–E571.

24. Arthur KK, et al. Detection of protein aggregates by sedimentation velocity analytical ultracentrifugation (SV-AUC): Sources of variability and their relative importance (p n/a). J Pharm Sci. 2009;doi 10.1002/jps.21654.

25. Berkowitz SA. Role of analytical ultracentrifugation in assessing the aggregation of protein biopharmaceuticals. AAPS J. 2006;8(3):E590–605.

26. Liu J, Andya JD, Shire SJ. A critical review of analytical ultracentrifugation and field flow fractionation methods for measuring protein aggregation. AAPS J. 2006;8(3):E580–89.

27. Pekar A, Sukumar M. Quantitation of aggregates in therapeutic proteins using sedimentation velocity analytical ultracentrifugation: Practical considerations that affect precision and accuracy. Anal Biochem. 2007;367:225–37.

28. Gabrielson JP, et al. Common excipients impair detection of protein aggregates during sedimentation velocity analytical ultracentrifugation. J Pharm Sci. 2009;98(1):50–62.

29. Schuck P. A model for sedimentation in inhomogeneous media. I. Dynamic density gradients from sedimenting co-solutes. Biophys Chem. 2004;108(1-3):187–200.

30. Schuck P, et al. Size-distribution analysis of proteins by analytical ultracentrifugation: Strategies and application to model systems. Biophys J. 2002;82(2):1096–1111.

31. Samavedam R, Morrison R, Kichefski T, Cote S, Rathore AS. Lifetime studies for membrane reuse: principles and case study. BioPharm Int. 2007;20(9):48–54.

32. Rathore AS, Sofer GS. Lifespan studies for chromatography and filtration media. In: Rathore AS, Sofer GS, editors. Process Validation. Marcel Dekker; 2005. p. 169–203.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

FDA Panel Unanimously Backs Secukinumab for the Treatment of Psoriasis
October 22, 2014
Roche to Expand and Improve its Basel Site
October 22, 2014
Pall ForteBio Releases Bioprocessing Contamination Detection Kit
October 22, 2014
EMA Works to Speed Up Ebola Treatment
October 20, 2014
Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9
October 20, 2014
Author Guidelines
Source: BioPharm International,
Click here