Analytical method validation for biotechnology proteins, peptides, and antibodies

LCGC North America

Volumn 27, Issue 7, 2009, Pages

  Swartz, Michael ^a   Krull, Ira ^a  

^a LCGC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 70350157913     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (23)

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5. I. Apostol. Private communication (January 2009).
6. International Conference on Harmonization (ICH), website: www.ich.org.
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11. Biogenerics 2008, Meeting held in Boston, Massachusetts, Spring, 2008, The Barnett Institute at Northeastern University.
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15. ICH Harmonised Tripartite Guideline, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Q6B, Current Step 4 Version, Dated 10 March, 1999, International Conference on Harmonisation, Geneva, Switzerland, www.ich.org.
16. ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2(R1), Current Step 4 Version, Parent Guideline on Methodology, dated 6 November 1996, incorporated in November 2005, International Conference on Harmonisation, Geneva, Switzerland, www.ich.org.
17. Guidance for Industry, Bioanalytical Method Validation, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine (CVM), Rockville, Maryland, May 2001.
18. MSB 09 Meeting, Boston, Massachusetts, February 2009, Microseparations in Biology, California Separations Society Meeting (CaSSS), www.casss.org.
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23. Carbohydrate Labeling and Analysis, PA800 Protein Characterization, Beckman Application Note, 2009, Beckman-CoulterCorporation, Fullerton, California.