Rapid Scale-up from the Bench to the Patient-deploying Single-use Technologies for the Manufacture o

来源 :2011第三届中国北京抗体大会 | 被引量 : 0次 | 上传用户:milamiya2009
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  The templatisation of the MAb purification process using scalable technologies has been instrumental in speeding up process development.However, one of the key bottlenecks to producing clinical material is the current long and costly step to design, build and validate the manufacturing facility and process.Prequalified, single-use technologies allow biopharmaceutical companies to significantly speed-up the deployment of the manufacturing operations anywhere in the world.The next step is an entire single-use MAb manufacturing process from the bioreactor to final formulation and filling that is optimized and is scalable from 1 kg to 5 kg of MAb.This presentation will discuss how a strong combination of proven single-use technologies and globally deployable expertise will aid the rapid scale-up of antibody manufacturing-anywhere in the world.
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