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Gala Biotech can provide the Cell Line Development capabilities
and the Biopharmaceutical Manufacturing capacity to take your
drug candidate from Gene to Clinic and Beyond.
| Cell Line Development |
Initial protein product in
four months and Master Cell Bank candidate in less than
six months. |
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| Process Development |
Cell line optimization and gram-scale production and
purification from small bioreactors. |
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| cGMP Manufacturing |
Phase I/Phase II cGMP production of clinical trial
material in bioreactors up to 200L. |
Gala will design a development program that meets your specific
goals. Normally, this begins with a milestone-based feasibility
study reflecting your product development plan. The result
of this study is typically the production of a stable high-expressing mammalian cell line and gram quantities of protein for your analysis
and preclinical needs.
At the conclusion of the feasibility study
you can outlicense the cell line for production at the facility
of your choice
or continue to work with
Gala Biotech for manufacture of cGMP product for Phase I/Phase
II clinical trials at our Middleton, Wisconsin facility.
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