@article{(Open Science Index):https://publications.waset.org/pdf/10004018,
	  title     = {Quality Based Approach for Efficient Biologics Manufacturing},
	  author    = {Takashi Kaminagayoshi and  Shigeyuki Haruyama},
	  country	= {},
	  institution	= {},
	  abstract     = {To improve the manufacturing efficiency of biologics, such as antibody drugs, a quality engineering framework was designed. Within this framework, critical steps and parameters in the manufacturing process were studied. Identification of these critical steps and critical parameters allows a deeper understanding of manufacturing capabilities, and suggests to process development department process control standards based on actual manufacturing capabilities as part of a PDCA (plan-do-check-act) cycle. This cycle can be applied to each manufacturing process so that it can be standardized, reducing the time needed to establish each new process.},
	    journal   = {International Journal of Economics and Management Engineering},
	  volume    = {10},
	  number    = {3},
	  year      = {2016},
	  pages     = {852 - 856},
	  ee        = {https://publications.waset.org/pdf/10004018},
	  url   	= {https://publications.waset.org/vol/111},
	  bibsource = {https://publications.waset.org/},
	  issn  	= {eISSN: 1307-6892},
	  publisher = {World Academy of Science, Engineering and Technology},
	  index 	= {Open Science Index 111, 2016},