The role of higher-order structure in defining biopharmaceutical quality

BioProcess International

Volumn 9, Issue 4, 2011, Pages 58-66

  Wei, Ziping ^a   Shacter, Emily ^b   Schenerman, Mark ^a   Dougherty, John ^c   McLeod, Lorna D ^d  

^a MEDIMMUNE   (United States)

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

^c ELI LILLY AND COMPANY   (United States)

^d NONE

Author keywords

Analytical methods; Biotinylation; Characterization; Protein folding

Indexed keywords

IMMUNOGLOBULIN G2; MONOCLONAL ANTIBODY;

BIOTECHNOLOGY; CHEMOLUMINESCENCE; DEUTERIUM HYDROGEN EXCHANGE; ELECTRON MICROSCOPY; ELECTRON TOMOGRAPHY; IMMUNOGENICITY; IN VITRO STUDY; MASS SPECTROMETRY; MICROCALORIMETRY; NUCLEAR MAGNETIC RESONANCE; PROTEIN EXPRESSION; PROTEIN POLYMORPHISM; REVIEW; THREE DIMENSIONAL IMAGING;

EID: 79955134302     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (1)

1. ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. US Fed. Reg. 70(125) 2005: 37861-37862; www.ich.org/fileadmin/Public-Web-Site/ ICH-Products/Guidelines/Quality/Q5E/ Step4/Q5E-Guideline.pdf.