JSR Life Sciences (JLS) recently announced that KBI Biopharma (KBI), a subsidiary of JSR Corporation (JSR), is expanding its biopharmaceutical manufacturing capacity and capabilities at both its Durham, North Carolina and Boulder, Colorado facilities. KBI is investing approximately $30M on the two site expansion projects, which will greatly enhance the offerings at each site and are scheduled for completion later this year.
KBI is building commercial mammalian cell culture manufacturing capability within its Durham facility, which also houses cGMP cell culture manufacturing lines for clinical production. KBI’s strong development capabilities and track record of success in clinical bulk drug substance manufacturing are the foundation for its expansion into commercial production. Upon completion of the project, the commercial manufacturing line will include 2 X 2000L single-use bioreactors and a full complement of recovery and downstream purification suites which will augment the facility’s already robust process development, analytical and formulation development services.
In Boulder, KBI currently offers commercial manufacturing capacity for microbial processes at 1500L scale, and is now building a second complete manufacturing train with 300L scale fermentation capability which leverages single use technologies. This additional, smaller-scale capacity will ensure that KBI can continue to meet the process development and clinical manufacturing needs of its clients, as well as commercial manufacturing needs for low-dose microbial products.
This expansion is a continuation of KBI’s ongoing growth following the acquisition of its cell therapy manufacturing facility in the Houston, Texas area this past February. KBI also plans to expand in Europe with the opening of an analytical services laboratory at JSR’s subsidiary, JSR Micro NV, in Leuven, Belgium in the first quarter of 2018. This expansion will allow KBI to serve the European market with the high value analytical characterization and cGMP testing services which remain at the heart of KBI’s business. The Belgium analytical lab will also facilitate the continued collaboration between KBI and JLS to expand and enhance JLS’ Amsphere A3 product line.
“These expansions support our vision for growth and create the opportunity to better serve our customers in all areas of the biopharmaceutical industry,” said KBI President Tim Kelly. “We are increasing our capacity for existing offerings and expanding into emerging technologies which will enable KBI to serve as a true partner and trusted advisor to our clients as our industry continues to grow.”
About KBI Biopharma
KBI Biopharma, Inc. is a biopharmaceutical Contract Development and Manufacturing Organization that accelerates the development of innovative discoveries into life-changing biological products. From early-stage to academic/non-profit organizations, to many of the world’s largest pharmaceutical companies, KBI has served 250+ clients globally to accelerate and optimize their drug development programs.
KBI’s extensive track record of successful programs is a result of its unique approach: applying the insight gained from our advanced biophysical and analytical protein characterization techniques toward the development of robust and scalable processes. KBI delivers accelerated and integrated process development and cGMP manufacturing programs for a wide range of recombinant protein Active Pharmaceutical Ingredients (API) and cell therapy products for our clients.
KBI was founded in 1996 and operates 4 facilities: Durham and Research Triangle Park (NC), Boulder (CO), and The Woodlands (TX).
About JSR Life Sciences Division
JSR Life Sciences Division is a business unit of JSR Corporation, which provides specialized materials and products to the biotech industry. JSR Life Sciences operates a network of manufacturing facilities, sales offices and R&D labs in key markets throughout North America, Europe and Asia-Pacific. JSR Life Sciences today is focused on diagnostics and research products and downstream bioprocessing materials for pharmaceutical manufacturing.
SOURCE: JSR Life Sciences (JLS)