ADCC讲座ADCC讲座.pdf

Promega ADCC检测法 © 2010, Promega Corporation. Confidential and Proprietary. Not for Further Disclosure. Biological Product Source: FDA webinar, Feb 15, 2012 Confidential and Proprietary. Not for Further Disclosure. 2 什么是Biologics:生物制药 US Biologics by 2010 Sales ($ billions) 9.7% growth nature biotechnology, volume 29, number 12, DECEMBER 2011 • 单克隆抗体药(mAb) 占生物制药市场的~ 1/3 • mAb = $48 billion in 2010, expected $86 billion by 2015 (CAGR) of 12.4% Confidential and Proprietary. Not for Further Disclosure. 3 Biologics Workflow Bioassay Use Is Critical Throughout Biopharmaceutical Drug Development Monitoring SCREENING POTENCY LOT RELEASE IMMUNOGENICITY POTENCY STABILITY COMPARABILITY STABILITY Therapeutic Post Launch Target Therapeutic Protein Pre-clinical Clinical Protein Patient Discovery Screen/Optimization Trials Trials Manufacturing Response Precision and accuracy are critical New solutions can solve shortcomings of c