Sharp, 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

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
Formulation/Product Development
Contract Manufacturing
- Tablets, capsules, powders, liquids, suspensions and semi-solids
- Wet granulation and dry blending
- Tablet compression and coating
- Encapsulation/Over-encapsulation
- Placebo manufacturing
Primary and secondary packaging of IMP (Investigational Medicinal Product) for clinical trials
Package design
Labeling
Comparator sourcing services
Global storage and distribution
Project management
Interactive Response Technology (IRT) / Inventory Management System (IMS)