Regulatory considerations when developing assays for the characterization and quality control of antibody-drug conjugates

American Laboratory

Volumn 44, Issue 8, 2012, Pages 26-31

  Shapiro, Marjorie A ^a,c   Chen, Xiao Hong ^b,c  

^a Office of Biotechnology Products (OBP)   (United States)

^b Division of New Drug Quality Assessment 1   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN BINDING; BIOLOGICAL MOLECULE; CYTOTOXIC; DRUG MOLECULES; MANUFACTURING PROCESS; POTENCY ASSAY; REGULATORY CONSIDERATIONS; RELEASE METHODS; STABILITY INDICATING METHOD; STABILITY TESTING; THREE COMPONENT; TUMOR CELL LINES;

ANTIBODIES; ANTIGENS; CELL CULTURE; CYTOTOXICITY; MOLECULES;

ASSAYS;

EID: 84866412163     PISSN: 00447749     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (3)

1. Castigne, S.; Pautas, C. et al. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomized, open-label, phase 3 study. The Lancet 2012, 379, 1508-16.
2. LoRusso, P.M.; Weiss, D. et al. Trastuzumab emtansine: a unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positive cancer. Clin. Canc. Res. 2011, 17, 6437-47.
3. Hudis, C.A. Trastuzumab - mechanism of action and use in clinical practice. N. Eng. J. Med. 2007, 357(1), 39-51.