PolyPeptide Torrance, USA
The Torrance, California site is a 120,000 square foot (~12,000 sq. meters) GMP manufacturing facility complex consisting of a series of specialized buildings.
This facility is designed to support mid and large scale solid-phase GMP peptide manufacturing, in quantities from multi-gram to multi-kilograms.
The facility has an area dedicated to development activities primarily to support GMP production through process development and process optimization. For GMP manufacturing, this facility supports 5 solid phase synthesis units, 3 intermediary processing laboratories, 7 purification suites, and several large scale tray lyophilization units. A state of the art QC lab has been established to support development and commercial activities. More recently, a GMP NeoAntigen Lab (NAPP™) has been built to support the growing field of Immunotherapy.
The Torrance manufacturing site is also engaged in the development and commercial manufacturing of oligonucleotides.
The Torrance facility has been successfully inspected multiple times by the US FDA and other international regulatory bodies with approvals for over 10 commercial Active Pharmaceutical Ingredients.
PolyPeptide San Diego, USA
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 typically up to 1 kg. The facility includes multiple solid phase synthesis suites, intermediary processing suites, purification suites and 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. The facility can also support production of isotopically labeled and radio-labeled peptides.
The San Diego facility has been successfully inspected multiple times by the US FDA and other international regulatory bodies.