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Our Melville facilities include on-site warehouse capabilities for storing both refrigerated and frozen material, and utility systems to support biological production.
Our facilities, equipment, processes and assays are validated and subject to a rigorous change control system.
We operate a water system which includes primary and secondary deionized water pre-treatment systems and two WFI distribution systems, each with 600 gallon per hour generating capacity and 5,000 gallon storage.
Four air handling systems with terminal HEPA filtration ensure appropriate controlled area and critical area conditions for a variety of manufacturing.
Systems & Capabilities:
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100,000 sq ft facility sits on 11 acres and includes Class 100,000 and Class 10,000 processing areas, Class 100 aseptic filling suites, and a protein extraction and purification facility |
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Microbiological and analytical testing services |
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Controlled temperature processing |
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Staffed for 24/7 operation |
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Formulation and process development and validation |
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Separation technologies |
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Test method development and validation |
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Aseptic filling of vials (2 mL to 50 mL) |
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