- Focusing on Development & Commercialization of Technologies to Reduce 
Manufacturing Process of Drug Delivery Systems, Including Liposomal & 
Lipid-based Nanoparticulate Formulations -

NAGASE & CO., LTD. ("NAGASE") and Osaka University ("OU") have launched DDS 
Products Joint Development Research Chair, a course dedicated to research in 
the development of production methods of liposomal formulations and lipid-based 
nanoparticulate formulations ("LNP"). Both are drug delivery system ("DDS") 
products, which are intended to offer solutions to issues such as metabolism of 
active pharmaceutical ingredients within the body before reaching the targeted 
tissues, or acting on tissues that causes adverse effects.

Logo: https://kyodonewsprwire.jp/img/202003037610-O1-v0m8k0b9

As DDS products, both liposomal and LNP formulations control how a drug 
functions by encapsulating active pharmaceutical ingredients in lipid 
particles. While garnering attention as a promising candidate for treatment for 
some of the refractory diseases that have no effective therapies to date, DDS 
products have problems before they could be commercialized, such as a 
complicated and long manufacturing process that results in higher manufacturing 
cost, and difficulties in increasing production yield (i.e. production 
scale-up).

Associate Professor Takashi Matsuzaki at the Department of Cardiovascular 
Medicine, Osaka University Graduate School of Medicine, has invented a 
technology for the production of liposomal and LNP formulations, with the use 
of a microfluidic device. By applying this new technology, the manufacturing 
process of these products will become shorter. It will also help overcome the 
obstacles in achieving production scale-up. OU has already reached agreement 
with the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency 
(PMDA), on the specifications and quality of liposomal formulations and has 
produced multiple investigational drugs using this technology.

NAGASE Group is introducing manufacturing equipment at one of its group 
companies, Nagase Medicals Co., Ltd. ("Nagase Medicals"). By applying this 
technology not only to low-molecular drugs, but also to Oligonucleotide drugs 
and gene therapy which represent the driving force of next-generation medicine, 
Nagase will further strengthen its contract development and manufacturing 
(CDMO) business, from formulation development to investigational drug and 
commercial production.

Technology features
- Potential to shorten the manufacturing process, which would take 4-5 days 
  using a conventional extruder, down to 1-2 days 
- The same parameters used in the investigational drug production may be used 
  for commercial production, which will make production scale-up simpler 
- Production with high reproducibility in terms of quality characteristics 
- Nagase Medicals ensures compliance with Japanese, U.S., and EU GMP 
  requirements as well as the PIC/S GMP 
- Easy transfer from other manufacturing methods has been demonstrated
- The technology has already been used in multiple investigational drug 
  production and supply


Source: NAGASE & CO., LTD.