Torrance Facility
In the US, PolyPeptide 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, in quantities from grams to multi-kilograms.
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 lyopholization suite. Approximately 2,000 square feet of the facility is devoted to non-GMP manufacturing and development for pre-GMP projects.
After completing a 10,000 square foot expansion, 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 site also offers dedicated QC and QA and regulatory personnel to support any project as it proceeds in clinical development. The facility has a proven track record, with 4 successful pre-approval inspections and one site inspection by the US FDA.
