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Bethlehem, PA, US

Sharp’s Bethlehem facility offers fully integrated clinical and small-scale commercial services.

Our site offers expertise in project management, clinical trial supply services including product development, manufacturing, analytical release and stability testing, clinical packaging, labeling, distribution, and IRT, as well as commercial packaging.

Our GMP facility also offers specialist infrastructure required for gene therapies, from HEPA air handling, monitoring temperature, humidity and dew point to full -80°C freezer banks in dedicated production suites, incorporating serialization into processing.

Facility Highlights

    • Optimal environment and specialist infrastructure
    • HEPA air handling
    • Temperature, humidity and dew point monitoring
    • Full -80°C freezer banks in dedicated production suites
    • 146,000 ft² facility including GMP production space, warehouse and offices
    • Ambient, refrigerated, and frozen packaging, storage and distribution
    • Enclosed primary and secondary suites
    • Controlled substance management
    • Gene therapy facility
        • Optimal environment and specialist infrastructure
        • HEPA air handling
        • Temperature, humidity and dew point monitoring
        • Full -80°C freezer banks in dedicated production suites

Contract Services

Clinical trial supply services

    • Analytical Services
        • HPLC Analysis (Waters, Agilent)
        • Dissolution Profile Testing
        • Moisture Content Determination (Volumetric and Coulometric)
        • FT-IR
        • UV Spectroscopy
        • TOC
        • pH and Conductivity
        • ICH Stability Testing

Commercial packaging services

    • Primary and secondary packaging of small-scale commercial products
    • Specialist gene therapy vial labeling and packaging
    • Kitting
    • Package design

Quality Accreditation

    • FDA inspected
    • DEA approved

Contact

2400 Baglyos Circle
Bethlehem, PA, 18020
United States
Tel: 484-765-9900
info@sharpservices.com

Allentown, PA, US – Building 1

7451 Keebler Way, Building 1, Allentown, PA 18106 United States

+1-610-395-5800

Allentown, PA, US – Building 4

7384 Penn Drive, Building 4
Allentown, PA 18106
United States

+1-610-395-5800

Conshohocken, PA, US

23 Carland Road,
Conshohocken, PA 19428,
United States

+1-610-279-3550
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