Sterile Fill-Finish Manufacturing
Producing parenteral dosage forms for small and large molecules from preclinical product development to commercial launch and supply
Our team has extensive commercial experience successfully processing small and large molecules. Finished product forms are a particular area of focus, which include liquids, lyophilized products, syringes, suspensions, emulsions, and terminally sterilized vials.
Dedicated to manufacturing parenteral dosage forms, our Charleston, South Carolina site supports preclinical production through commercial launch and supply. This US- and EU-compliant and DEA-licensed sterile manufacturing facility is fully integrated with our Wilmington, North Carolina packaging and distribution center. We have recently expanded our sterile drug product capabilities with the acquisition of a new state-of-the-art fill-finish manufacturing facility located in Morrisville/RTP, NC. The 32,000 ft2 location includes isolator manufacturing capabilities for liquid and lyophilized vial and syringe products.
CHARLESTON, SC CAPABILITIES
- 39,000ft² dedicated to parenteral manufacturing and laboratory support services
- OEL Levels: Down to SafeBridge Categorization (3A) = > 1-10µg/M3
- Sterile solutions, suspensions, and emulsions
- Grade A and Grade B areas: Filling, capping, sterilized component staging
- Grade C: Compounding, component, preparation, microfluidization, sampling/dispensing
- Grade D: Equipment washing and quarantine storage of cleaned equipment
- 100% visual inspection
- FDA, EMA, MHRA, and cGMP-compliant
RTP, NC CAPABILITIES
- Four filling lines with isolator technology for liquid and lyophilized vial and syringe products
- Low line loss single-use systems for compounding and product transfer processes
- Terminal sterilization available 2Q 2021
- Nitrogen overlay capable in both syringes and vials
- Incoming materials & finished product storage temperatures: -80°C, -20°C, 5°C, and controlled room temperature (CRT)
- OEL levels: Down to SafeBridge categorization (3A) = > 1-10µg/M3
- 100% manual visual inspection of all units
- On-site laboratory support
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