Search results for: biologics
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 1

Search results for: biologics

1 Quality Based Approach for Efficient Biologics Manufacturing

Authors: Takashi Kaminagayoshi, Shigeyuki Haruyama

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: Antibody drugs, biologics, manufacturing efficiency, PDCA cycle, quality engineering.

Procedia APA BibTeX Chicago EndNote Harvard JSON MLA RIS XML ISO 690 PDF Downloads 1584