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cGMP Manufacturing Sites |
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St. Louis, MO USA (Bio-organic Synthesis) |
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cGMP Bio-Organics is
located in the Cherokee building and is an FDA approved cGMP facility for
medium and large scale manufacturing of products that require flammable
solvents during processing. This facility performs extractions, organic
reactions, crystallization, filtration and shelf drying. The cGMP Bio-Organcis
operation also has process development capabilities.
| Overview |
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This facility has over 14,000
ft² of manufacturing space and a production staff of 19 employees |
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The products targeted for manufacture
in the cGMP Bio-Organics facilities include lipids, detergents, buffers,
polyamino acids, carbohydrates and other custom processes derived
from a variety of natural and synthetic sources that use flammable
solvents in their process. |
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Multi-faceted facility features
fully validated equipment, complete segregation, enclosed processing,
USP purified water, process control, HEPA filtered air, environmental
control and Validated Cleaning-In-Place (CIP) system. |
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SAFC is investing $16 million to expand its cGMP protein purification capacity to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials.
Read press release. |
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Optimum reaction time and conditions |
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Inert to all chemical conditions |
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In-line control versus off-line analysis
increased process efficiency |
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Increased process efficiency |
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Thermodynamic reaction control |
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Optimum reaction temperature
and dosing speed |
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Increased yields |
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Safer scale-up |
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Increased process safety |
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Enzymatic reactions |
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Reverse osmosis |
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