Next Generation MAb Facilities: Future Lifecycle Facility Design for Development and Production-Cost

来源 :2011第三届中国北京抗体大会 | 被引量 : 0次 | 上传用户:sh_duoduo
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  Modem production technologies and novel facility design philosophies have the potential to revolutionize the business case for MAb development and production facilities.Bringing MAb products from development to production introduces considerations about the long tem facility life cycle and how a pragmatic future oriented perspective can ensure project success.The challenge is not only process and technology driven-factors like quality system, analytical program, technology transfer and organizational competences are also part of the synthesis necessary for successful bridging from development to commercial production.The presentation uses selected case studies of MAb projects to illustrate features of next generation of MAb facilities that include the above factors.Production technologies, capacity, timelines and costs are described for typical MAb facilities with special emphasis on obtaining cGMP compliance and flexibility in a cost effective way.The impact of modern quality approaches Quality by Design and ASTM-E2500 verification is shown with respect to both quality improvement and time and cost savings.
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