## Curative medicine, Diagnostic products

## Life Sciences

## GMP production of Plasmid DNA Vector

Keyword: Plasmid DNA for Genetherapy, Clinical trial Phase 2, Collaboration with BioVenture company

Organizations Involved

○ Masaru Nagamine, Associate Professor, Center of Molecular Bioscience (COMB), University of the Ryukyus

○ Masanao Kikukawa, CEO, Institute of Advanced Medical Biological Science

○ Kiichi Teruya, Professor, Center for Cooperative Research, University of the Ryukyus,

## 【Abstract】

Local joint center of the University of the Ryukyus does a matching of company and researcher.

Technological Seed of COMB University of the Ryukyus and industrialization Technology of AMBiS developed a plasmid DNA simple and easy extraction method for industry use, and have acquired a patent. Using this method, production of plasmid DNA for clinical use was achieved.

## 【Summary of the technology transfer】Technological Impact

It is possible to easily perform large-capacity solid-liquid separation/ buffer solution exchange / concentration by getting rid of centrifugal separation operation in the closed system, which utilizes TFF membrane, decreasing the burden on environment in pharmaceutics factories.

It reduces environmental burden on factories, and will lead to reduced operational costs of gene-recombination technology application pharmaceutics factories.

## ●Market Impact

Dozens of mg purified Non-GMP plasmid DNA vectors were able to be marketed at decreased prices while maintaining high quality.

## ●Social Impact

The aim is to further spread clinical studies and clinical trials, to develop a plant where GMP production of plasmid DNA is possible, which can be used up to clinical trial phase II.

To support clinical trials as contract based production of drugs

In the “Post Genome” age, research and development of molecular target medicine is very active and early stage non-clinical and clinical tests (phase I and phase II) are sought. It is necessary to enhance the efforts to support new drug discovery.

●Special Features of the Collaboration

Stimulate and motivate researchers to collaborate with venture companies.

## Project Background

AMBiS and the COMB University of the Ryukyus which grouped for a new business development are given a grant by New Energy and Industrial Technology Development Organization (NEDO) Regional Consortium Technology

## Funding History

## GMP vector production facility

1. Year 2000 NEDO “A venture company that supports regional consortium technology business”. 2. 2002 Small business corporation “Provide grants to new businesses for start-up”

3. 2004-2006 Okinawa Prefecture “Bio-Venture company Research and Development support business”

Plasmid DNA production at AMBiS

## I ntellectual property protection

Device and process for purifying Vectors

US6773913B2 Japan No3547715

Hetero-Pentermer recombinant vaccine

Patent application No2003-412053

PCT/JP2004/010459 EU4,747,848,2

## Turning point in the Project

Industrialization of seeds utilizes the venture company support measure that each ministry and government office carry out.

Experts who can strategically raise funds and government support are sought.

For more information, contact: Toshihiro Higa, Research Cooperation Section, Science and International Affairs Division, University of Ryukyus, +81-98-895-8038, kntiki@to.jim.u-ryukyu.ac.jp