Implementation of a platform approach for early biologics development

American Pharmaceutical Review

Volumn 14, Issue 6, 2011, Pages 87-91

  Siedler, Michael ^a  

^a Abbott GmbH and Co KG   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

AMINO ACID SEQUENCE; ANTIBODY ENGINEERING; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG SCREENING; HUMAN; IMMUNOGENICITY; MEDICAL TECHNOLOGY; SHORT SURVEY;

EID: 80054948505     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (3)

1. J.M. Reichert, Metrics for antibody therapeutics development, Mabs (2010), 2(6): 695-700.
2. ICH Harmonized Tripartite Guideline: Pharmaceutical Development Q8(R2). Step 4 version, Aug. 2009.
3. CMC Bio Working Group 2009. A-MAb: A Case Study in Bioprocess Development. Version 2.1, California Separation Science Society.