San Diego FacilityThe San Diego facility in the US occupies 45,000 sq. ft. of which 27,000 sq.ft. are currently developed. This facility manufactures GMP grade as well as research grade peptides.
The site has been manufacturing peptides according to cGMP since 1990. It is equipped for mainly solid-phase synthesis and is designed to handle lot sizes from a few grams to several kilogram quantities using either Fmoc or tBoc chemistry. Design features include 3 solid phase synthesis units, 2 intermediary processing laboratories, 2 purification & isolation laboratories and an additional 18,000 sq. ft. available for future expansion.
Research peptides are also manufactured in milligram to gram quantities. The services also include production of isotopically labeled and radio-labeled peptides. Peptides utilized in pre-clinical studies are also manufactured at larger scale at this facility.
The San Diego facility has been inspected by the FDA 7 times. 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 API. The San Diego Facility currently produces two approved drug substances in Europe and Japan and two diagnostic components for the US market.
The Torrance facility in the US has a 40,000 square foot state-of-the-art GMP manufacturing facility. This facility was designed to mainly support large scale solid-phase GMP peptide manufacturing using either Fmoc or tBoc chemistry, in quantities from multi-10-gram to multi-kilogram quantities.
For GMP manufacturing, the Torrance facility supports 5 solid phase synthesis units, 3 intermediary processing laboratories, 4 purification & isolation laboratories,1 separate isolation unit, and a large scale (200 kg ice capacity) tray lyophilization suite. Approximately 2,000 square feet of the facility is devoted to non-GMP manufacturing and development for 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 manufacture. The facility has a proven track record, with 4 successful pre-approval inspections and one 2 site inspections by the US FDA. It has also been successfully inspected by the Korean FDA.