Assessment of AMBRTM as a model for high-throughput cell culture process development strategy英文文献资料.docVIP

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 Sarath Moses , Matthew Manahan , Alexandre Ambrogelly , Wai Lam W. Ling 1* 1 2 1* 1 2 Upstream Process Development Operations, Bioprocess Development, Merck Research Laboratories, Union, USA Analytical Development, Bioprocess Development, Merck Research Laboratories, Union, USA sarath.moses@, Email: * * 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 ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) endorsed guidelines for ICH Q8/Q9/ Q10/Q11 implementation, [1] focuses on ensuring the quality of the therapeutic products to be safe and effica- cious, and provides guidance on risk assessment and management on product quality control through identify- cation of critical quality attributes (CQAs) and critical process parameters (CPPs). Our ongoing efforts in ap- plying Quality by Design (QbD) approaches in high throughput cell culture systems are one of the strategies in assessing the product quality changes during devel- opment while balancing the resource and timeline con- straints. The ongoing efforts in the biopharmaceutical industry to balance the increased workload required to address process and product quality control coupled with the reduced resources availability have heightened the im- plementation of HTP systems to s