@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}, }