Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 30458
Quality Based Approach for Efficient Biologics Manufacturing

Authors: Shigeyuki Haruyama, Takashi Kaminagayoshi

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.

Keywords: Quality Engineering, Biologics, PDCA cycle, antibody drugs, manufacturing efficiency

Digital Object Identifier (DOI): doi.org/10.5281/zenodo.1112306

Procedia APA BibTeX Chicago EndNote Harvard JSON MLA RIS XML ISO 690 PDF Downloads 1151

References:


[1] Junichi Matsuzaki, The present situation and the problem of biologics, The society for biotechnology, Japan, 91(9) 2013.
[2] Takahiro Fujimoto, Successful product development, Yuhikaku, Tokyo, 2000, pp. 105-128.
[3] Hirokazu Sugiyama, Business model of continuous improvement in pharmaceutical production processes, the 23rd European symposium on computer aided process engineering, 2013.
[4] Japan pharmaceutical manufacturers association guide book 2012-2013, Japan pharmaceutical manufacturers association, 2013, pp.
[5] Specification testing, manufacturing and application for antibody drugs, Science & Technology, Tokyo, 2009, pp. 134-142.
[6] CMC study, application and acquisition of equivalency in biopharmaceutical / antibody drugs / biosimilar, Science & Technology, Tokyo, 2011, pp. 17-25.
[7] Jin Seok Seo, et al, Effect of culture pH on recombinant antibody production by a new human cell line, F2N78, grown in suspension at 33.0 degree C and 37.0 degree C, Appl. Microbiol. Biotechnol., 5283, 97, 2013.
[8] Genichi Taguchi, Taguchi method handbook, Keisaikai, Tokyo, 2006, pp. 28-89.
[9] Takahiro Fujimoto, Japanese process industries, Tokyo, 2009, pp. 110-134.