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| Toyobo has been actively involved in the development
of biopharmaceuticals using genetic recombination mammalian cell
culture technology since it entered the medical field in 1979.
PAC Biologics began contract manufacturing in 1994 and since then
it has contributed to "Toyobo's Biotech" in its role as one of
the few domestic manufacturers that can handle the research, development
and production of raw bio-pharmaceuticals under contract. In November
of 2001, the biopharmaceutical contract manufacturing section was
separated from the pharmaceutical division of Toyobo and reorganized
as PAC Biologics Inc. |
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| The world's biopharmaceutical market is rapidly
growing with antibody pharmaceuticals at the head of the
pack. However, their development requires heavy investments
in facilities as well as highly specialized knowledge. In
light of this, companies are turning to biotech contract
manufacturers in order to avoid investment risks and take
advantage of their expertise. As a contract manufacturer,
TBI has addressed these requirements and has gone so far
as to build the largest plant in Japan with a 4,000L bioreactor
for mammalian cells where manufacturing can be carried out
compliance with cGMP standards in keeping with PBI's goals
of providing global compliance. |
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| The concept and layout of the plant containing
the multipurpose 4,000-liter bioreactor for mammalian cells
developed in conjunction with the start of TBI and the equipment
related to scaling up operations as well as the facilities
for refining the bioreactor quality of the culture liquid
gotten from them were considered at a FDA Type C Meeting
in 2002 and evaluated to be "acceptable". Validation was
completed in the spring of 2004 and the plant has begun operations.
The existing culture plant with a 600-liter bioreactor as
well as the manufacturing plant comply with domestic GMP
standards and have already amassed a long record of successes. |
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| 2007 Copyright Toyobo Biologics Inc. All Rights Reserved. |
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