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Introduction of Biologics Manufacturing Support Unit (BMS)

Manufacturing Technology Association of Biologics (MAB), which the Bio-Manufacturing Support Unit (BMS) belongs to, is a technology association granted under "R&D of Next-Generation Therapeutic Antibodies that Meet International Standards" by the Ministry of Economy, Trade and Industry from FY2013 to FY2014 and by Japan Agency for Medical Research and Development (AMED) from FY2015 to FY2017, and "High-quality Biologics Manufacturing Technology" by AMED from FY2018 to FY2020. With the grant, MAB is supervising approximately 40 organizations and developing platform technologies for next-generation biopharmaceutical manufacturing from cell lines to cultivation, downstream, quality control, and process integration. MAB has three project lines, which are R&D Theme related of Antibody, R&D Theme related of Gene & Cell therapy, and R&D Results Acceleration Project. (MAB)

BMS (not the name of a pharmaceutical company) is in R&D Results Acceleration Project in MAB and establishing a test method to quantitatively determine the manufacturability of academia-derived biopharmaceutical seed protein (Pro-X). BMS continues working to contribute to developing Pro-X and establishing an ecosystem to support its practical application by feeding back the Pro-X manufacturability test data to the seed developers supported by the Drug Discovery Support Network. In plain terms, we are developing and implementing technologies to assess whether the seed proteins from academia are not difficult to produce on a commercial basis even it has remarkable function, i.e., the seed protein can be mass-manufactured as pharmaceuticals. In recent years, we have expanded our activities and provided researchers in academia with not limited to antibodies but also proteins required for pharmacological assessment as an aid to promote drug discovery studies in academia that is proceeded by AMED.

The characteristics of protein acquisition in the BMS are as follows:

1. Expression cells with high-expression-level can be prepared by using CHO-MK cells produced by the MAB domestically
   
2. Above-mentioned cells propagate very rapidly and its doubling time is about 10 hours. Using well-known antibodies as an indicator, the protein expression levels achieved more than 10 g/L-culture. Based on our previous activities, we believe that the certain g/L level of normal antibody can be achieved relatively easily. On the contrary, if the productivity is low with the cell, it is considered to be expression-difficulty proteins and has a problem such as in stability, and required to change amino acid sequence and so on.
   
3. In case of future practical application, it is not necessary to pay a large amount of loyalty to foreign companies because it is a cell created as a national measure. Although MAB requests loyalty, it is considerably less expensive than paying abroad.
   
4. Though it is charged separately, purified Pro-X proteins expressed in CHO-MK cells is continuously provided. According to requests, we purified cells up to the pharmacologically tested level (endotoxin-free, etc.).

While consulting with AMED, we will continue to cooperate in accelerating drug discovery research for academia.

Reference: The iD3 Booster (AMED iD3 Catalyst Unit | The iD3 Booster)

Hitoshi Sakashita, Ph.D.
Manager
Manufacturing Technology Association of Biologics