We’ve been working on the "Project Focused on Developing Key Technology for Discovering and Manufacturing Drugs for Next-Generation Treatment and Diagnosis"（Next-generation biologics manufacturing conforming to global standards） implemented by the Japan Agency for Medical Research and Development（ AMED） from FY2021, as following subjects.

-R&D subject 1:

Technology for manufacturing next-generation therapeutic antibodies

-R&D subject 2:

Physical properties, quality evaluation and control methods for next-generation therapeutic antibodies

-R&D subject 3:

Implementation of original high-performance antibody-producing cell lines

-R&D subject 4:

Advanced simulation technology for biopharmaceutical manufacturing process

This project is being undertaken by MAB, which consists of Japanese companies, universities and public research institutions in biologics manufacturing.

Research Consortium

-FY2021~FY2025-
"Next-generation biologics manufacturing conforming to global standards"

(October 01, 2024)

*

GMP : Abbreviation for Good Manufacturing Practice
Quality control standards for pharmaceutical products, etc., which are based on the Pharmaceutical Affairs Law of Japan, as well as the manufacturing quality control standards for pharmaceutical products, etc. established by the US Food and Drug Administration.

High-quality Biologics Manufacturing Technology (FY2018-FY2020)

Establishment of advanced therapeutic antibodies manufacturing technology

R&D subjects

Continuous production of therapeutic antibodies

◦Production cells

◦Quality control

◦Perfusion Cell culture

◦Virus safety management

◦PCC chromatography

Consolidated manufacturing technology (Engineering run)

Construction of continuous manufacturing process platform

◦Integrated type (Complete continuous manufacturing line)

◦Hybrid type (Combination batch process)

Assessing the large scale manufacturability of biopharmaceutical seeds

Manufacturing technology for next-generation antibody drugs that meet International standards
(FY2013-FY2017)