Using peptide maps as identity and purity tests for lot release testing of recombinant therapeutic proteins

BioPharm International

Volumn 16, Issue 4, 2003, Pages 54-58

  Dougherty, John ^a   Mhatre, Rohin ^b   Moore, Stephen ^c  

^a ELI LILLY AND COMPANY   (United States)

^b BIOGEN   (United States)

^c Center for Drug Evaluation and Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT PROTEIN;

AMINO ACID SEQUENCE; DRUG DETERMINATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG RELEASE; DRUG STRUCTURE; FOOD AND DRUG ADMINISTRATION; MEDICAL SOCIETY; PEPTIDE MAPPING; PRACTICE GUIDELINE; REVIEW;

EID: 0037392987     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. Allen, D. et al., "Validation of Peptide Mapping for Protein Identity and Genetic Stability," Biologicals 24, 255-275, (1996).
2. ICH, Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, Q5B: Step 5, CPMP/ICI/139/95 (Geneva, 1995). Also in Federal Register 61(133), 36465-36469 (10 July 1996).
3. ICH, Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, Q5B: Step 5, CPMP/ICI/139/95 (Geneva, 1995). Also in Federal Register 61(133), 36465-36469 (10 July 1996).
4. Dougherty, Jr., J.J. et al., "High Performance Tryptic Mapping of Recombinant Bovine Somatotropin," Anal. Biochem. 190, 7-20 (1990).
5. Chloupek, R.C. et al., "Study of the Primary Structure of Recombinant Tissue Plasminogen Activator by Reversed-Phase High-Performance Liquid Chromatographic Tryptic Mapping," J. Chromatography 463, 375-396 (1989).
6. Bongers, J. et al., "Validation of a Peptide Mapping Method for a Therapeutic Monoclonal Antibody: What Could We Possibly Learn About a Method We Have Run 100 Times" J. Pharm. Biomed. Anal. 21, 1099-1128 (2000).
7. ICH, Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Q6B: Step 5, CPMP/ICH/365/96 (Geneva, March 1999). Also in Federal Register 64(159), 44928-44935 (18 August 1999).
8. ICH, Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Q6B: Step 5, CPMP/ICH/365/96 (Geneva, March 1999). Also in Federal Register 64(159), 44928-44935 (18 August 1999).