American Peptide Company is expanding its large scale cyclic guanosine monophosphate peptide, or cGMP, synthesis capabilities at its 35,000 square foot Vista, California
production facility, with the addition of a 300 Liter solid phase synthesis reactor and a 294 Liter tray lyophilizer.
The company said the new equipment will allow it to produce multi-kilograms of active pharmaceutical ingredients in individual batches. Large scale peptide synthesis helps make the process more economical and shortens delivery times.
The 300 Liter solid phase synthesis reactor is one of the largest in the U.S. peptide contract manufacturing industry. The 294 Liter tray lyophilizer has 15 square meters of shelf space and is the largest in the peptide CMO industry, the company said. Two additional 50 Liter tray lyophilizers have also been recently added to their cGMP facility.
In addition, its 294 Liter tray lyophilizer is equipped with a Clean In Place skid to eliminate cross contamination between batches. The temperature of each step is controlled, and the conductivity of the water is monitored. The control system includes full PLC automation with 21 CFR parts 210, 211 compliant operation and a well-documented SOP. These new pieces of equipment are complimented by an existing array of synthesis reactors, lyophilizers and large scale purification columns.