Uniting small molecule and biologic drug perspectives: Analytical characterization and regulatory considerations for antibody-drug conjugates

BioProcess International

Volumn 9, Issue 8, 2011, Pages 12-22

  Harris, Jon ^a   Jacobson, Fred ^a   Jochheim, Claudia ^b   Amphlett, Godfrey ^c   Francissen, Kathleen ^a   McLeod, Lorna ^d  

^a GENENTECH INC   (United States)

^b CMC Consulting   (United States)

^c IMMUNOGEN INC   (United States)

^d NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY CONJUGATE; ANTIBODY DRUG CONJUGATE; CALICHEAMICIN; DODECYL SULFATE SODIUM; GEMTUZUMAB OZOGAMICIN; IMMUNOLOGIC AGENT; MAYTANSINE; MONOCLONAL ANTIBODY; NEW DRUG; SOBLIDOTIN; UNCLASSIFIED DRUG;

ANALYTIC METHOD; CAPILLARY ELECTROPHORESIS; COMPARATIVE STUDY; DRUG CONJUGATION; DRUG DETERMINATION; DRUG IMPURITY; DRUG QUALITY; DRUG RESEARCH; DRUG STABILITY; DRUG STRUCTURE; DRUG SYNTHESIS; ENZYME LINKED IMMUNOSORBENT ASSAY; GEL PERMEATION CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IMMUNOGENICITY; QUALITY CONTROL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; REVIEW;

EID: 80053190403     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (9)

1. CBER. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. US FDA: Rockville, MD, 28 February 1997.
2. ICH Q6A. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. US Fed. Reg. 65(251) 2000: 83041-83063.
3. ICH Q6B. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. US Fed. Reg. 64, 1999: 44928.
4. ICH Q3A(R2). Impurities in Drug Substances. US Fed. Reg. June 2008.
5. ICH Q3C(R5). Impurities: Guideline for Residual Solvents. US Fed. Reg. 62(247) 1997: 67377.
6. ICH Q3B(R2). Impurities in New Drug Products. US Fed. Reg. 68(220) 2003: 64628-64629.
7. ICHQ8(R2). Pharmaceutical Development. US Fed. Reg. November 2009.
8. ICH Q7. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. US Fed. Reg. 66(186) 2001: 49028-49029.
9. ICH Q11 Concept Paper. Development and Manufacture of Drug Substances. International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use: Geneva, Switzerland, April 2008.