San Diego and Torrance, USA
San Diego, California
The San Diego, California site is a 45,000 square foot facility (~4,500 sq. meter). This facility manufactures GMP grade peptides for clinical application as well as research grade peptides.
For GMP manufacturing this site is equipped for mainly solid-phase synthesis and is designed to handle lot sizes from a few grams to several kilograms. Design features include 3 solid phase synthesis suites, 2 intermediary processing suites, 2 purification & isolation suites.
Approximately 4,000 square feet (~400 sq. meters)of the facility is devoted for manufacturing of research peptides in milligram to gram quantities, including production of isotopically labeled and radio-labeled peptides, and development for pre-GMP projects. More information about our labeling capabilities can be found here.
The San Diego facility has been inspected by the US FDA 12 times, including a PAI inspection in 2009. This site has also been inspected by the Korean FDA, and approved by Japan's Ministry of Health, Labor and Welfare for manufacturing and sale of a commercial API.
Torrance, California Facility
The Torrance, California site is a 40,000 square foot (~4,000 sq. meters) GMP manufacturing facility. This facility was designed to mainly support large scale solid-phase GMP peptide manufacturing, in quantities from multi-10-gram to multi-kilograms.
For GMP manufacturing, this facility supports 5 solid phase synthesis units, 3 intermediary processing laboratories, 4 purification & isolation laboratories,1 separate isolation unit, and a large scale tray lyophilization suite (200 kg ice capacity).
Approximately 2,000 square feet of the facility is devoted to non-GMP manufacturing and development of pre-GMP projects.
The facility is set up to support any peptide project from small scale, non-GMP manufacturing, through development, to large-scale, GMP-grade, commercial manufacturing. The facility has a proven track record, with 6 successful pre-approval inspections and 3 site inspections by the US FDA. It has also been successfully inspected by the Korean FDA.