Kishi Kasei Co., Ltd. (President: Daisuke Maezawa) and Spera Pharma, Inc. (President: Toshio Yoshioka) have agreed to a business collaboration combining Kishi Kasei’s contract manufacturing of Biomaterials and Spera Pharma’s biopharmaceutical investigational drug manufacturing capabilities.
Kishi Kasei constructed a biopharmaceutical manufacturing plant in their H & B Center at Kanazawa-ku in Yokohama, and established service offerings since February 2017, including cell line development, cell banking and storage, and bioprocess development. Kishi Kasei also started services for the manufacture of biopharmaceutical drug substances, using two single-use-type 1000 L culture tanks for animal cells in GMP-compliant facilities, in accordance with ICH and PIC/S standards. The services are also available for the commercialization of bio drug substances.
Spera Pharma was established in July 2017 at Yodogawa-ku, Osaka, specializing in CMC research, which includes process chemistry, formulation development, and analytical development for the manufacture of investigational drugs. The company is a CDMO that inherits resources, expertise and capabilities from Takeda Pharmaceutical Company and has extensive experience in preparation for the manufacture of GMP investigational drugs, as well as studies on the formulation of biopharmaceuticals, evaluation of formulation and scale up.
Through a business collaboration that exploits the strengths of both companies, it will become the first company collaboration in Japan to provide services that combine both investigational drug manufacture and drug substance manufacturing for contract biopharmaceutical development. The collaboration will contribute to promoting biotechnology development at a speedier, more detailed and higher quality. This initiative will actively help to strengthen the international competitiveness of Japan’s domestic biopharmaceutical business.
Both companies have agreed on concrete terms and conditions concerning the business collaboration, and they are now proceeding in good faith to conclude the contract as soon as possible.