Contract Services | Toyobo Biologics Inc.

Entrust TBI with your cell line.
TBI's Culture Group provides you with the following services

•	Cell line selection ; Screening of high production cell lines.
•	Creation and storage of MCB and WCB
•	Development of Culture Process
•	Scaling up consideration
•	Manufacture of preparations for clinical trials, cultures for pharmaceutical production ; Done in compliance with the FDA cGMP standards.

All types mammalian cells can be handled, including suspension cells and adherent cells. Batch, Fed-Batch, Perfusion and other types of cultures can be created on a scale that meets your requirements. Any amount from a single flask up to 4,000liters can be accommodated to give you the volume you needed. We can also provide wide-ranging support from the basic research up through the manufacture of preparations for clinical trials and pharmaceutical preparations.

TBI's Purification Group can handle the following.

•	Structuring of purification procedure for target proteins.
•	Scaling up consideration.
•	Manufacture of preparations for clinical trial production; Done in compliance with the FDA cGMP standards.

TBI provides support for orders ranging from a single gram to kilograms. Strong support is available at all stages ranging from the level of basic research through the manufacture of the clinical trial preparation up to the final manufacture of the target pharmaceutical. Purification-only contracts are also accepted.

TBI's Quality Control Group handles the following.

•	Receiving testing of raw materials.
•	Process management testing.
•	Shipment testing.
•	Set-up and validation of various test methods.
•	All types of stability tests, etc.

Requests for tests and individual inspections are also accepted.

[ Toyobo support ]

The revised Pharmaceutical Affairs Law issued in July 2002 removed all constraints on pharmaceutical manufacture contracting. TBI ties to Toyobo's Pharmaceutical Division make it possible for us to handle all of the processes from the productionof raw biopharmaceuticals to their final preparations. This provides You with many advantages when you use our services.

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