Development of an in-house, process-specific ELISA for detecting HCP in a therapeutic antibody, Part 2

BioProcess International

Volumn 9, Issue 4, 2011, Pages 68-75

  Savino, Edward ^a   Hu, Bing ^a   Sellers, Jason ^a   Sobjak, Andrea ^a   Majewski, Nathan ^a   Fenton, Sandra ^a   Yang, Tong Yuan ^a  

^a NONE

Author keywords

Data analysis SDS PAGE; Host cell protein; Immunoassays; Sp 2 0 cells; Staining; Western blotting

Indexed keywords

CELL PROTEIN; IMMUNOGLOBULIN G;

CELL LYSATE; COMMERCIAL PHENOMENA; DRUG CONTAMINATION; DRUG MANUFACTURE; ENZYME LINKED IMMUNOSORBENT ASSAY; GEL ELECTROPHORESIS; HOST CELL; IMMUNE RESPONSE; IMMUNOREACTIVITY; PROTEIN ANALYSIS; REVIEW; SENSITIVITY AND SPECIFICITY; STAINING; STANDARD; WESTERN BLOTTING;

EID: 79955150105     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (3)

1. WHO Technical Report Series No. 878. WHO Expert Committee on Biological Standardization: Forty-Seventh Report. World Health Organization: Geneva, Switzerland, 1998.
2. Office of Biologics Research and Review. Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology. US Food and Drug Administration: Rockville, MD, 1995.
3. ICH Q6: Specifications - Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva, Switzerland, 1999.