JSR Life Sciences Expands US Biopharma Plants
JSR Life Sciences (JLS), a division of Japan’s JSR Corp., is expanding its biopharmaceutical manufacturing capacity in the US. JLS subsidiary, KBI Biopharma (KBI), is spending about $30 million to extend its capabilities at its plants in Durham, North Carolina and Boulder, Colorado. Both projects are scheduled for completion later this year.
KBI is building commercial mammalian cell culture facilities at the Durham site, which also houses cGMP cell culture manufacturing lines for clinical production. The investment will see two 2,000 liter single-use bioreactors installed as well as a full range of recovery and downstream purification suites that will enhance the plant’s existing process development, analytical and formulation development services.
At the Boulder plant, which currently offers commercial manufacturing capacity for microbial processes at 1,500 liter scale, KBI is building a second train with 300 liter scale fermentation capability to leverage single-use technologies. KBI said the additional smaller-scale capacity will ensure that it can continue to meet the process development and clinical manufacturing needs of its customers.
In addition, JSR subsidiary, JSR Micro, also plans to open an analytical services laboratory in Leuven, Belgium, in the first quarter of 2018, allowing it to offer analytical characterization and cGMP testing services to the European market.
The Belgian laboratory will also facilitate the continued collaboration between KBI and JLS to expand and enhance JLS’ Amsphere A3 product line. JLS said Amsphere A3, a next-generation protein A chromatography resin used for advanced antibody purification, has been rapidly adopted since its launch in January 2016. As a result, production in Leuven is being expanded by six times its current level, although the company did not give any actual figures.
The first phase of the expansion started earlier this year with plans to be fully operational in 2018. JLS said the multi-phased project will keep pace with growing demand for Amsphere A3 with the total additional capacity due for completion by the end of its fiscal year 2019.
JLS was formed in April 2016 as its Tokyo parent wanted to leverage its material and polymer expertise to expand into bioprocessing and diagnostic and research products. In bioprocessing, JLS focuses on large-scale purification and chromatography products including Amsphere A3. JSR acquired a majority stake in contract development and manufacturing organization KBI Biopharma in 2015.