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| (Toyobo Biologics Inc. and Pharmaceuticals Division of
Toyobo Co. Ltd.): |
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Structured joint development agreements involving
Japanese and international pharmaceutical companies for the development
and commercialization of three recombinant protein drugs (t-PA,
EPO and mutant t-PA)
in Japan. Two of these products, t-PA and EPO, were successfully
developed through PLA approval and NDA application, respectively.
The production process included all phases, from master cell bank
construction to parental drug production. |
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Demonstrated negotiation skills and in/out-licensing
expertise during numerous joint development projects involving
Japanese pharmaceutical companies, for both recombinant proteins
and small molecule or peptide drugs (HGF, ALR, SCGF, MSP, MMDF,
TYB-2285; anti-allergy, TYB-1382; anti-arrhythmic from Hungary). |
| • |
Completed contract manufacturing and development
projects for 32 recombinant protein drug candidates, including
ten monoclonal antibodies for 22 Japanese companies as of September
2004. |
| • |
TOYOBO has completed, on average, about two hundred
contract manufacturing and development projects per year for both
Japanese and international pharmaceutical companies. Projects range
from production for, and fill and finish of, tablet dosages for
preclinical, clinical and commercial use; formulation studies;
QC testing; stability testing; and packaging. |
| Assisted US biotech companies and Japanese pharmaceutical licensees
on regulatory and technical issues leading to approval in Japan
of a new recombinant protein drug and a new peptide drug. |
• |
Joint development of two organic compound drugs
in TOYOBO’s original DDS (Trans-mucousal Therapeutic System)
with Japanese pharmaceutical companies. |
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Developed an extensive network with many US biotech
companies and universities through prior business development activities. |
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Established strong connections with over sixty
Japanese pharmaceutical companies though the contract manufacturing
and development of drug candidates for more than ten years. |
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| 2007 Copyright Toyobo Biologics Inc. All Rights Reserved. |
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