Sunnyvale, CA (PRWEB) August 26, 2013
American Peptide Company (APC) announces the expansion of their large scale cGMP peptide synthesis capabilities with the addition of a 300 Liter solid phase synthesis reactor and a 294 Liter tray lyophilizer.
American Peptide’s state of the art 35,000 square foot cGMP facility is located in Vista, California. The 300 Liter solid phase synthesis reactor is one of the largest in the U.S. peptide CMO industry. The 294 Liter tray lyophilizer has 15 square meters of shelf space and is the largest in the peptide CMO industry. Two additional 50 Liter tray lyophilizers have also been recently added to their cGMP facility.
The 294 Liter tray lyophilizer is equipped with a Clean In Place (CIP) 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.
With the expansion of their large scale cGMP synthesis capacity, American Peptide Company can produce multi-kilograms of active pharmaceutical ingredients in individual batches. Large scale peptide synthesis helps make the process more economical and shortens delivery times.
About American Peptide Company, Inc.
American Peptide Company (APC) is a leading manufacturer of peptides and peptide conjugates. The company offers comprehensive selections of pre-manufactured catalog peptides, custom synthesis, and GMP peptide active pharmaceutical ingredients (APIs). Our California based manufacturing facilities offer synthesis services under Non GMP (Sunnyvale, California) and cGMP (Vista, California) conditions. Our cGMP manufacturing is performed under strict adherence to FDA Regulations 21 CFR parts 210, 211 and ICH Guidance Q7A. Our Total Peptide Management services support clients in the drug development process from pre-clinical thru commercial stage. Our value added services include process development, scale up production, analytical/process validation, stability studies, CMC, DMF, and regulatory support.
For more information, please visit http://www.americanpeptide.com.
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