%0 Journal Article
	%A Takashi Kaminagayoshi and  Shigeyuki Haruyama
	%D 2016
	%J International Journal of Economics and Management Engineering
	%B World Academy of Science, Engineering and Technology
	%I Open Science Index 111, 2016
	%T Quality Based Approach for Efficient Biologics Manufacturing
	%U https://publications.waset.org/pdf/10004018
	%V 111
	%X 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.
	%P 852 - 856