Your Expertner

[Our Consultants]

Atsushi Yasumoto President: Entered the research and development department of General Incorporated Foundation, The Chemo-Sero-Therapeutic Research Institute (Kaketsuken) in 2001 and involved in commercialization of genetically modified protein product, manufacturing clinical product, engineering the manufacturing plant for biological drug product, organizing the SOPs, regulatory management and factory management.
Entered CM Plus Corporation, a consulting company in 2013, building experience in engineering management and GMP consulting in and outside Japan. Established Nexredge Inc. in 2015 and supported various developments of biological products, cell therapy products including GCTP compliance management of CPCs.
Shinichiro Hayashi Executive Vice president: Entered General Incorporated Foundation, The Chemo-Sero-Therapeutic Research Institute (Kaketsuken) in 2001. As well as being involved in the production management and plant management of the vaccine manufacturing, built experience in the facility design, engineering, improving the manufacturing process and GMP activities such as deviation, change and validation control. Was also involved in the project management of the single use plant dealt with the regulatory including GMP compliance review, major change application (as change control).
Joined Nexredge Inc. in Oct. 2016 and has been helping in building GMP management system, obtaining approval and validation activities for companies developing biological or cell therapy products.
- Member of sterile products GMP committee of Parental Drug Association Japan Chapter.
Mikitomo Yasutake Executive Offcer: Joined Asahi Kasei in 1987. Seconded to a medical device company as a person in charge of blood purification devices from design to manufacturing and quality assurance, and gained experience in CE marking and FDA audits. As a development manager, launched 5 products including blood filters. Involved in the establishment of the cell processing center for cord blood banking, quality system development, and related research at The Institute of Medical Science, Univ. of Tokyo. Received Ph.D. in medicine from the Univ. of Tokyo in 2006. Returned to Asahi Kasei in 2010, served as Quality Assurance Manager and General Manufacturing/Marketing Supervisor in Asahi Kasei's Corporate Research Division, while also leading healthcare R&D through joint research with academia in the fields of cell and gene therapy (CGT), including CAR-T and iPS cell-based regenerative medicine. Appointed Principal Expert in Bio, the head of the company's highly professional system, in 2023. Joined Nexredge in 2024. Strengths in leveraging research and business experience to formulate development strategies for CGT products and medical devices.
Sotaro Gokudan Director, GxP Division: Joined the Institute of Chemistry and Serum Therapy in 1999 and acquired knowledge and experience in manufacturing and quality control of biologics in the manufacturing and development divisions, including manufacturing management and validation of biopharmaceuticals, and establishment of commercial processes and analytical methods. He moved to Quality Assurance division from 2007 and gained much experience about various QA operations as well. From 2014, he worked as the represent person of the urgent project team for internal compliance investigation. He also concurrently served as head of regulatory affairs section, and managed applications and facility license.
In 2017, he started to work for the regenerative medicine industry and joined Nikon Cell Innovation, which is engaged in CMO for regenerative medical products. As head of Quality division and facility supervisor, he contributed to the start-up of a new facility and oversighted the establishment of the quality system.
In November 2020, he moved Takeda Pharmaceutical Company Limited. He worked as a lead of management for audits/ inspections and GMP improvement for the sterile injection and regenerative medical products. In addition, he was also responsible for education and training at the site.
In April 2024, he joined Nexredge inc.
Masakatsu Nishihachijo Director, Engineering Division: Entered Kaneka Corporation in 2005. In the research and development department, in charge of process development of pharmaceutical intermediates using enzymatic reactions for about 9 years, and then responsible for development of purification materials and purification technology for biological products for about 8 years. Built experience in research and development related to manufacturing processes for various biological products, including the development of affinity chromatography resin for the purification of a monoclonal antibody, the processes development for recombinant protein products, and the research and development of process development and analytical technology of viral vectors for gene therapy. Joined Nexredge Inc. in 2022. In charge of research and development and manufacturing support for biopharmaceuticals and regenerative medicine.
- Professional Engineer Japan (Biotechnology & Bioengineering): Registration No. 70129
Syoujyu Kameyama Senior Consultan, GxP Division: Entered GREEN CROSS CORPORATION (Currently, Mitsubishi Tanabe Pharma Corporation) in 1981. In the research and development department, in charge of development of biologics and recombinant protein products, production technology research, investigational drug production, and CMC for various protein drugs.
Entered Yokohama Bio Research and Supply, Inc. in 2007. Responsible for construction support of clinical trial drug manufacturing facilities, launch of a contract manufacturing business for genetically engineered proteins, manufacturing research support, construction of cGMP system, maintenance of SOP, management of the entire facility, application support for GILSP.
Entered Earth Environmental Service Co. Ltd in 2013 as academic advisor. Responsible for research support of hygiene management and environmental monitoring of pharmaceutical and medical equipment manufacturing plants, and hygiene management for products such as regenerative medicine.
Entered Nexredge Inc in 2019. Responsible for construction support of manufacturing facilities of medicines and medical devices to advice and support for hygiene management of manufacturing facilities and research and development and manufacturing support for biopharmaceuticals (genetically engineered products-products such as regenerative medicine).
Ken Uchino Consultant, GxP Division: Entered the research and development department of sterile medicinal product plant, FUJI YAKUHIN Co., Ltd in 2009. In charge of analytical method development, production technology research, investigational drug production, establishment of the aseptic emulsified formulation manufacturing system.
Entered the product engineering department of the oral solid dosage plant, Nihon Pharmaceutical Industry Co., Ltd in 2014. In charge of improving the manufacturing process, analytical method development. GMP activities such as validation control (process validation activities after changes, ongoing process verification, etc.) and calibration management in the testing laboratory. From 2017 to 2022, worked as a deviation deputy manager. Was also involved in support for technology transfer to an overseas manufacturing plant.
Joined Nexredge Inc. in 2022 and provided support as a start-up of manufacturing facilities for a regenerative medicine product company, for the establishment of GMP/GCTP systems, relocation of the testing laboratory, preparation of various procedures as an on-site person.
- The Senior Scientist of Pharmaceutical Technology of APSTJ
- Pharmacist
Keita Koba Consultant, GxP Division: Entered Senju Pharmaceutical Co in 2018. In the quality control department, Engaged in analytical work (physical methods, chemistry methods and raw material testing) for ophthalmic solutions.
Also in charge of technology transfer from the company's own laboratories and other companies' manufacturing facilities to the company's own manufacturing facilities, as well as establishment and revision of SOPs and other GMP documents. From 2020 to 2022, worked as a supervisor. Was involved in various activities such as the assessment of the test results, the development of the laboratory environment in accordance with the revision of ministerial ordinances and updating the company's LIMS (Laboratory Information Management System) system.
Also in charge of preparing for and attending inspections by the prefectural government, PMDA, and Russian authorities, as well as audits of Marketing Authorization Holder.
In 2022, was transferred to Quality Assurance department and worked as a complaints manager. In cooperation with the manufacturer and other departments in the plant, contributed to improvement of process and product quality by enhancing the system of manufacturing facilities and the monitoring system in the manufacturing process.
Entered Nexredge Inc. in 2023. As a field representative, worked on the development of procedure manuals, etc. as support for the establishment of GMP system for investigational new drugs.
- Pharmacist
Kenji Nahara Sales Dept: Joined Shin-Daikyowa Petrochemical Company (now Tosoh Corporation) in 1987.
Engaged in research on synthesis of C4-C9 fractions of petrochemicals and process improvement at the Yokkaichi Research Laboratory, petroleum refining process.
He acquired knowledge of the petroleum refining process, its catalytic reactions, and plant operation and management. As part of the project, he participated in a national project for catalyst development.
In 1993, he joined Nalco Japan K.K., the Japanese subsidiary of Nalco Chemical. He was in charge of planning and sales of process chemicals for petroleum refining and petrochemicals, as well as water treatment chemicals, and was engaged in proposal-based business to solve customers' problems through chemical processing.
In 2003, he joined General Electric Company and was assigned to GE Betz Japan, the Japanese division of GE Betz, which was established with the launch of GE Betz. He was in charge of developing new customers and managing the business unit.
In 2006, GE Betz Division was merged with other divisions to form GE Water & Process Technologies Division, and he was transferred from Chemicals Division to Equipment Division. In the Equipment Division, he was in charge of indirect sales with GE's distributors and engineering companies as partners.
He was in charge of developing new partners, distributor contracts, technical tie-ups and technology transfer contracts with engineering companies, introduction of new technologies, and the closure of existing JV companies.
Sales Dept
Sales Dept
Chikako Yamauchi Senior Consultant, GxP Division: Since 1984, Entered in exploratory research of new drugs for 7 years at the University of Tokyo Hospital and Bristol-Myers Squibb K.K.
Since 1993, entered in clinical development for 15 years at Allergan K.K. and Genzyme Japan K.K. Experienced in research of new pharmaceutical drugs, clinical monitoring, data management, planning of product development, protocol development, NDA, inspection works, PMDA consultation/communication, medical writing, SOP preparation, operational system development, project management and leadership.
Since 2011, entered Parexel International Inc., a global CRO, and engaged in clinical development. Most recently, approx. 3 years experiences of Japan country head of clinical operations.
In 2020, launched a consulting business on pharmaceutical affairs and clinical development.
Satoru Adachi Adviser Affiliated Consultant: Entered the research and development department of General Incorporated Foundation, The Chemo-Sero-Therapeutic Research Institute (Kaketsuken) in 1983, and involved in development project of recombinant hepatitis B vaccine, recombinant biologics pharmaceuticals, production of clinical trial material, production control and quality control, quality assurance for GMP, development of blood product, and clinical development.
Entered Quintiles Transnational Japan K.K. for responsible of regulatory affairs division and regulatory affairs consultant in 2008.
Entered Takeda Pharmaceutical Company Ltd for responsible of clinical development of vaccine division, as well as be charged in responsible of regulatory affairs and CMC division.
After retire Takeda Pharmaceutical Company Ltd, established BR LINKS which is Biotechnology and Regulatory Consultant in 2019.
At present, entrusted consultant business from some company, and worked for consultant of process development for biologics, CMC, clinical research and development, submission of pharmaceutical sales approval and overall business for pharmaceutical development, etc..
Charged for senior consultant in Nexredge Inc.