Nagase, Osaka University Launch Research Program

Nagase and the University of Osaka have launched a research chair in joint development of drug delivery system products (SAM), a course dedicated to research into the development of production of liposomal formulations and lipid-based nanoparticle formulations (NPL). Both are products of drug delivery systems (SAM) designed to provide solutions to issues such as the metabolism of active pharmaceutical ingredients (APIs) in the body before they reach targeted tissues, or until they do not act on the tissues and cause undesirable effects.
 
As SAM products, both liposomal and NPL formulations control the way a drug works by encapsulating the APIs in the lipid particles. While attracting attention as promising candidates in the treatment of certain refractory diseases for which there is no effective therapy to date, SAM products presented problems before they could be marketed, in particular a long and complicated manufacturing process which increased manufacturing costs, and difficulties in increasing production output (i.e., scaling up production).
 
Takashi Matsuzaki, associate professor in the department of cardiovascular medicine at the faculty of medicine at Osaka University, invented a technology for the production of liposomal and NPL formulations using a microfluidic device. By applying this new technology, the manufacturing process of these products will be shortened. It will also help overcome obstacles to scaling up production. Osaka University has already entered into an agreement with the Japanese regulatory agency, the Pharmaceutical and Medical Devices Agency (PMDA), on the specifications and quality of liposomal formulations and has produced multiple experimental drugs using this technology.
 
The Nagase Group is currently introducing manufacturing equipment to one of its group companies, Nagase Medicals. By applying this technology, not only to low molecular weight drugs, but also to oligonucleotide drugs and gene therapy which are the driving force of next generation medicine, Nagase will strengthen its contract development and manufacturing activity from the development of formulations to the production of experimental drugs and to commercial production.

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