Transpacific Advisory Services | Toyobo Biologics Inc.

The TBI Consulting Group is a consulting and advisory service that provides assistance to US and European biopharmaceutical companies in establishing strategic relationships with Japanese pharmaceutical companies. TBI Consulting Group’s founders have developed a strong network of personal contacts within the Japanese pharmaceutical over the past twenty years, and have extensive experience in the development and manufacturing of biopharmaceuticals while at Toyobo Co., Ltd. (TOYOBO). TOYOBO itself has a long history in the biopharmaceutical field, beginning in the early 1980’s when it in-licensed two recombinant protein drug candidates from a US biotech company and successfully developed the two compounds in Japan. During this period, TOYOBO developed in-house all of the production capabilities required for approval of new protein drugs in Japan, including establishment of master cell banks, construction of mammalian cell culture facilities and protein purification plants, as well as development of the related QA/QC procedures and testing. On the basis of such accumulated know-how and technology, TOYOBO began conducting contract mammalian cell culturing and manufacturing of recombinant protein drug candidates in 1994. In November 2001, the biopharmaceutical contract manufacturing section was spun out from the Ohtsu Pharmaceutical Plant of TOYOBO and reorganized as PAC Biologics Inc. (PBI).

In 2004, PAC Biologics introduced its new PBI Consulting Group as a means of offering US and European biotech companies which are developing recombinant protein drugs, especially antibodies, with a targeted introduction to Japanese companies which are considering in-licensing of such recombinant protein drugs. In addition to its introductory services, PBI Consulting Group can also assist client companies on a wide range of technical and regulatory issues. Contract production for clinical-stage supply of protein therapeutics is also available within PAC Biologic’s start-of the-art facilities.

PBI Consulting Group is dedicated to providing a full range of advisory services to meet any and all needs of our biopharmaceutical clients. PBI Consulting Group’s parent company, Toyobo biologics, and TBI ’s parent company, TOYOBO, have experience working with a variety of overseas companies and universities for in-licensing and technical collaborations, and we can tailor our advisory services to fit your needs.

The PBI Consulting Group has both the expertise and network to assist your Company in the following areas:

•	Identification of and introduction to Japanese pharmaceutical firms who are interested in developing recombinant protein drugs via in-licensing of new candidates.
•	Production of preclinical and clinical protein drug supply, including process development, as part of a licensing agreement between the US biotech and Japanese companies.
•	Assistance with all phases of the pharmaceutical approval process in Japan, including preparation of regulatory filings.
•	Production of recombinant protein drug materials and drug product for commercial use, if appropriate.

Our Experience PBI | PBI Consulting Group

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