Protein Characterization Through the Stages - Biomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products. - BioPharm International

ADVERTISEMENT

Protein Characterization Through the Stages
Biomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products.


BioPharm International Supplements


Summary

As the biopharmaceutical industry continues to evolve, so must its analytical techniques. Protein characterization plays a critical role in determining the safety and efficacy of biological products, and as such there is a need to continue to improve the accuracy, sensitivity, specificity, and robustness of protein assays, and to develop novel assays that target specific areas of concern. Biomanufacturers must leverage their experience and knowledge to determine which methods to apply at each stage of the drug development process, and use a risk-based approach to guide their selection. Collaboration between manufacturers and regulatory agencies is critical in the ongoing search for an answer to the question—How well characterized is well characterized enough?

Lisa Crossley, PhD, the founder and principal of BioVentures, Ontario, Canada, 888.405.9549,

References

1. Morrow KJ. Tools for protein structure characterization. Gen Eng Biotech News. May 2008;28(9).

2. Magil S. Biopharmaceutical characterization techniques for early phase development of proteins. BioPharm Int. Guide to Bioanalytical Advances. Sept 2005; p. 34–42.

3. Towns J, Webber K. Demonstrating comparability for well-characterized biotechnology products: Early phase, late phase, and post-approval. BioProcess Int. Feb 2008:6(2):32–43.

4. Krishnamurthy R, Sukumar M, Das T, Lacher N. Emerging analytical technologies for biotherapeutics development. BioProcess Int. May 2008;6(5):32–42.

5. US Food and Drug Adminsitration. Guidance for Industry. Q6B specifications: Test procedures and acceptance criteria for biotechnological/biological products. Rockville, MD; Aug 1999.

6. Dougherty J, et al. Postapproval changes for large-scale biopharmaceutical manufacturing: Global regulatory issues. Langer ES, ed. In: Advances in large-scale biopharmaceutical manufacturing. ASM Press: Washington, DC, 2004; pp. 555–91.

7. Patten PA, Schellekens H. The immunogenicity of biopharmaceuticals: lessons learned and consequences for protein drug development. Brown F, Mire-Sluis AR, editors. Immunogen Therapeutic Bio Prod.

8. Aldridge S. Next-generation protein characterization. Gen Eng Biotech News. Apr 2006;26(7).

9. Lipp, E. Characterizing Proteins to Bolster Pipelines. Genetic Eng Biotech News. June 2010; 30(12).

10. Vivian JT, Callis PR. Mechanisms of tryptophan fluorescence shifts in proteins. Biophys J. 2001;80(5):2093–109.

11. Wales TE, Engen JR. Hydrogen exchange mass spectrometry for the analysis of protein dynamics. Mass Spectrom Rev. 2006;25(1):158–70.

12. Berkowitz SA. Role of analytical ultracentrifugation in assessing the aggregation of protein biopharmaceuticals. AAPS J. 2006;8:590–605.

13. 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;96:268–79.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Launches Human Safety Study of Ebola Vaccine Candidate
August 29, 2014
Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
USP Awards Analytical Research
August 15, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here