Sterile Products Manufacturing

AAIPharma Services' sterile products manufacturing facility is located in Charleston, South Carolina. Our 48,000 sq. ft. Charleston facility develops and manufactures sterile products for small molecules, biologics and proteins.

We offer:

  • USFDA and MHRA approved GMP-compliant manufacturing facility
  • Phase I to commercial manufacturing with batch sizes up to 320L
  • Manual vial filling as small as a few hundred vials to automated vial filling of about 20,000 vials/batch
  • Scheduled compounds: II-IV with vault space
  • Lyophilization, terminal sterilization, and aseptic filling
  • Emulsion Expertise (microfluidization)
  • Two explosion-rated Compounding Rooms
  • Two grade B (Class 100) clean rooms
  • Potent Compound Isolator for Compounding
The Charleston facility is also fully integrated with our Wilmington facilities, which offer complementary services including analytical, formulation development and clinical packaging services specifically tailored to support sterile product manufacturing.