assessment of ambrtm as a model for high-throughput cell culture process development strategy评估ambrtm作为高通量细胞培养过程的模型发展战略.pdfVIP

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assessment of ambrtm as a model for high-throughput cell culture process development strategy评估ambrtm作为高通量细胞培养过程的模型发展战略.pdf

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assessment of ambrtm as a model for high-throughput cell culture process development strategy评估ambrtm作为高通量细胞培养过程的模型发展战略

Advances in Bioscience and Biotechnology, 2012, 3, 918-927 ABB /10.4236/abb.2012.37113 Published Online November 2012 (http://www.SciRP.org/journal/abb/) Assessment of AMBRTM as a model for high-throughput cell culture process development strategy 1* 1 2 1* Sarath Moses , Matthew Manahan , Alexandre Ambrogelly , Wai Lam W. Ling 1Upstream Process Development Operations, Bioprocess Development, Merck Research Laboratories, Union, USA 2Analytical Development, Bioprocess Development, Merck Research Laboratories, Union, USA * * Email: sarath.moses@, wai_lam.ling@ Received 20 August 2012; revised 27 September 2012; accepted 11 October 2012 ABSTRACT tems to enhance data outputs and program decision in the cell culture process development area. In addition, recent The development and delivery of high quality thera- ICH (International Conference on Harmonisation of peutic products necessitates the need for highthrough- Technical Requirements for Registration of Pharmaceuticals put (HTP) process development tools. Traditionally, for Human Use) endorsed guidelines for ICH Q8/Q9/ these works requires a combination of shake flask Q10/Q11 implementation, [1] focuses on ensuring the and