Manufacturing Technology Association of Biologics

Project Description

Gene Therapy

Outline

We've been working 'Research and development of new technologies on large scale production of viral vectors for gene and cell therapy' aligned with 'Research and development of core technologies for gene and cell therapy' supported by the Japan Agency for Medical Research and Development(AMED) since FY2018.
We have being aiming to develop elemental technologies and build a manufacturing technology platform that is supposed to comply with regulations for conducting clinical trials in order to realize large scale production of viral vectors for gene and cell therapy.

R&D Subjects

Research and development of new technologies on large scale production of viral vectors for gene and cell therapy (FY2018~2023)

Manufacturing process of virus vector and R&D themes

Mass manufacturing technology

R&D Items

1. Development of elemental technology

  1. ① Construction of production cell line suitable for viral vector production
  2. ② Development of upstream technology
  3. ③ Development of downstream technology
  4. ④ Development of analytical technology
  5. ⑤ Construction of manufacturing technology platform

2. Proof research in consolidated laboratory

R&D organization

Figure System for R&D (April 1,2022)

Kusatsu Consolidated Lab.

Kawasaki Consolidated Lab.

Osaka Consolidated Lab.

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