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SAFC Pharma® – St. Louis Facility
Biologic APIs and Conjugation
| SAFC St. Louis – Missouri (USA)
SAFC Pharma's St. Louis, Missouri (USA) campus is a key center of manufacturing excellence with 25 years experience in cGMP biologics.
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| Facility Overview: |
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Completely segregated manufacturing operations |
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Large-scale capacity to extract biomass at up to 6,500 kg/week up to |
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Purification in 1.5 m of diameter chromatography columns |
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Extensive analytical capabilities and dedicated compliance |
Animal-sourced APIs Manufacturing
Purpose-built, completely segregated facilities have been specifically designed to support animal protein extraction and purification at commercial scale, to meet growing customer demand for animal-sourced therapeutic proteins.
Manufacturing for sample projects includes: |
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Thrombin (wound care) |
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Hyalruonidase (eye care) |
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Porcine/bovine sourced Trypsin |
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Wide variety of excipients (such as Keyhole Limpet Hemocyanin) |
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Plant-sourced APIs
Dedicated upstream plant biomass extraction and clarification facility equipped to process up to 6,500 kg of plant biomass/week.
Facility features: |
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Separate cGMP plant extraction and downstream purification |
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Purification ISO 7 and ISO 8 classified suites |
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Unidirectional process flows |
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Equipment wash room |
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Fixed, stainless steel jacketed biopharm grade tanks to 3,200 L |
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Disposable technology availability |
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Delta V control system, central Clean In Place (CIP) skid chromatography and TFF skids |
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Bio-organic APIs Synthesis and Purification
SAFC Pharma offers a wide range of bio-organic cGMP APIs, adjuvants, excipients and intermediates serving both the pharmaceutical and biopharmaceutical industries.
Manufactured from both natural and synthetic sources, our offer includes:
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Lipids |
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Detergents |
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Buffers |
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Polyamino Acids |
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Carbohydrates |
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Custom solvent sanitization blends |
Our fully validated facility offers reactor and crystallization capacity up to 3,000 gallons and vacuum filtration capability of up th 0.6 square meters for up to 100K kg of finished product batches within a temperature range of –20 °C to 120 °C.
Potent and Non-Potent Conjugation
To support exciting new cancer drugs, SAFC Pharma is one of the few companies to offer the crucial combination of small-molecule chemistry, biologics capabilities and high-containment engineering to bring HPAPI conjugates to commercialization.
Non-potent conjugates, primarily used for targeted drug delivery applications, are also available.
The new cGMP HPAPI conjugation facility features: |
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800 sq. ft. floor space |
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ISO 8 (Class 100,000) room classification |
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Walker™ dual-sided six glove isolator |
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10-100 L reactor size |
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Batch size capability over 100 g |
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