Formulation
Development
  • Formulation
    • Preformulation
    • Characterization
    • Stability Studies
  • Biopharmaceutical
Analytical
Chemistry
Manufacturing
Services
  • Formulation & Scale-Up
    • Process Scale-Up
    • Process Validation
    • Investigational Supplies
    • Clinical Supplies
    • Commercial Supplies
Packaging
& Distribution
  • Clinical Packaging
    • Design Support
    • Kitting
    • Debulking and Overpacking
    • Device Assembly
    • Manual & Semi-Automated Solid Dose Bottle Filling
    • Thermoform/Coldform Blisters
    • Secondary Packaging
  • Clinical Labeling
    • Label Development & Proof
    • Randomization & Blinding
    • Multi-Lingual Open & Blinded Labeling
  • Commercial Packaging
    • Packaging of Vials, Bottles, & Blisters
    • Repackaging of Commercial Products
    • Label Development & Labeling
    • Cartoning
    • Inventory Management
  • Global Distribution
    • Controlled Storage
    • Validated Shipments
    • Reconciliation/Destruction
Support
Services
  • Stability Management
    • Stability Study Design
    • Stability Trending
  • Stability Testing
  • Regulatory Support
    • Strategy Consultation & Guidance
    • Full CMC Services
    • Agent Representation
    • Liaison Activities
    • Global Experience
ABOUT AAIPHARMA

AAIPharma Services' facilities in Charleston, South Carolina feature a scientific and technical staff that has the proven experience and expertise in developing and manufacturing parenteral products, with the capability and flexibility to deliver batches for your clinical studies and medium-scale commercial needs.

We offer:

  • State-of-the-Art Facility located in Charleston, SC
  • Development and Manufacturing of Sterile Products for Small Molecules and Biologics, including Proteins, Peptides, Monoclonal Antibodies, and other Large Molecules
  • 48,000 sq. ft. USFDA and EMA approved cGMP Compliant Manufacturing Facility
    • Two Grade B (Class 100) Clean Rooms
    • 54 sq. ft. Lyophilizer
    • Terminal Sterilization Capacity
    • DEA Compliant (Controlled Substances)
    • Class 100 Capping
  • Batch Size from 200ml up to 340L
  • Terminal Sterilization and Lyophilization