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cGMP Manufacturing Sites |
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St. Louis, Missouri USA : Aqueous Extraction & cGMP Purification |
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Our 20,000 square foot
aqueous extraction/cGMP purification facility can process over 60,000 pounds
of biomass per week from plant, animal, or microbial source. cGMP purification
is performed at our 800 square foot, class 10,000 purification suite or
100 square foot, class 100 purification suite, using a wide range of operations
including; large-scale chromatography, ultrafiltration, and asceptic filling.
The suites are supported by HEPA-filtered air. The equipment and USP water
system supporting this facility are all fully validated.
Final product can be lyophilized in our validated lyophilizers. Products requiring
low bioburden and low endotoxin can be loaded and sealed in LyoGard® freeze
dry bags in class 100 cleanrooms, lyophilized in the bag, and either opened and
packaged in the class 100 room or shipped to you directly.
SAFC recognizes the increased need for non-animal proteins.
The market trend is to express the proteins in plants and then extract the protein
from the plants. Sigma-Aldrich has over 50 years of experience in extracting
proteins from a large variety of plants. SAFC has the
capability and the capacity to process over 60,000 pounds of biomass per week.
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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Apyrase from potatoes |
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Recombinant Avidin, expressed in corn |
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Forskolin from coleus forskohili |
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ß-Glucoronidase, bacterial, recombiant,
expressed in corn |
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Inulin from chicory root or dahlila tubers |
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Lectins |
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Peroxidase from horseradish roots |
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Phloridzin from applewood |
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Trypsin Inhibitor from soybean |
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Urease from jack bean |
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