AAIPharma's 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.
Our Charleston facility develops and manufactures sterile product dosage forms for small molecules, biologics and proteins. We have the capability of filling 2-50 mL vials (automated) as well as hand-fills for unique presentations. We can process batch sizes up to 320L using aseptic techniques as well as provide terminal sterilization and lyophilization to meet your needs. Our recently constructed 48,000 sq. ft. USFDA and MHRA approved cGMP compliant manufacturing facility has two grade B (Class 100) clean rooms, a 54 sq. ft. lyophilizer, terminal sterilization capacity and is DEA compliant (Controlled Substances.
Our Charleston facility, albeit a stand alone plant, is also fully integrated into our Wilmington facilities which offer complementary services including analytical, formulation development and clinical packaging services specifically tailored to support sterile product manufacturing.
