A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products—Part 1 - Currently, there is no industry-wide guideline about the process f

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A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products—Part 1
Currently, there is no industry-wide guideline about the process for establishing specifications for biologicals at different stages of the product lifecycle. The Working Group on Specifications and Formulations of the PhRMA Biologics and Biotechnology Leadership Committee set out to help fill this gap. The first of a three-part article.


BioPharm International
Volume 21, Issue 6

REFERENCES

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3. Koren E, Zuckerman LA, Mire-Sluis AR. Immune response to therapeutic proteins in human—clinical significance, assessment and prediction. Curr Pharm Biotechnol. 2002;3:349–360.

4. Graves DJ, Martin BL, Wang JH. Co- and post-translational modification of proteins. Chemical principles and biological effects New York: Oxford University Press; 1994.

5. Apostol I, Kelner D. Managing the analytical lifecycle for biotechnology products: A journey from method development to validation. BioProcess Int. 2008; in press.

6. Horwitz W, Albert R. A heuristic derivation of the Horwitz curve. Anal Chem. 1997;69: 789–790.

7. ASTM. Standard Practice for using significant digits in test data to determine conformance with specifications. In ASTM Designation: E 29–04 ed. 2005; p 1–5.

8. Holme DM, Peck H. Analytical Biochemistry. 3rd ed. Upper Saddle River, New Jersey: Prentice-Hall, Inc.; 1998, p 9–19.

9. Agut C, Segalini A, Bauer M, Boccardi G. Relationship between HPLC precision and number of significant figures when reporting impurities and when setting specifications, J Pharm Biomed Anal. 2006;41:442–448.

10. International Conference on Harmonization. Q2R1, Validation of analytical procedures. Geneva, Switzerland; 2005, p 1–13.

11. Ritter NM, Advant SJ, Hennessey J, Simmerman H, McEntire J, Mire-Sluis A, Joneckis C. What Is test method qualification? Proceedings of the WCBP CMC strategy forum, 24 July 2003. BioProcess Int. 2004;2,32–46.


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