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Biomanufacturing |
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From Gene to
Clinic and Beyond, Gala can support all of your mammalian cell
line creation and biomanufacturing needs: |
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- cDNA to stable mammalian cell line in less than six months
- Research-scale protein production in roller bottles and/or
small
bioreactors for process development
- Scale-up to Phase I
material in small bioreactors
- cGMP manufacturing of Phase
I/Phase II clinical material in
100L bioreactors
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There are several advantages to this gene-to-clinic
approach to biomanufacturing: |
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- All operations from cell line development
through production of
Phase II clinical material are performed in a single facility
- Seamless
technology transfer for production
of Phase III and commercial-scale material
- Both facilities
are equipped with similar bioreactor systems and standard
operating procedures, leading to increased
consistency, stability, and favorable lead times
for adaptation and scale-up.
- Single point of project management
across all aspects of gene-to-clinic projects — client only deals with one “contact”.
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Catalent Pharma Solutions -- North Raleigh, North Carolina |
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In addition to large-scale manufacturing, Catalent Pharma Solutions provides: |
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- Product development
- Formulation
- Assay development
- Lyophilization
- Release testing
- Stability testing
- mAb conjugation: toxins and radioisotopes
- Sterile fill-finish
- Sales/Marketing/Distribution of final
product
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