CSBio received an initial Drug Manufacturing License for GMP production in 2001 for our San Carlos, CA facility. In 2004 we opened our state of the art peptide production facility in Menlo Park, CA with a primary focus on GMP peptide manufacturing. Our goal is to provide our customers with the highest quality compounds available, in a time frame that matches our customer’s requirements. Our GMP peptide production facility has been issued a Drug Manufacturing License by the State of California Department of Health Services, Food and Drug Branch. This license is only issued after a thorough audit by the Food and Drug Branch, and the license must be renewed on a yearly basis. Our approach to GMP manufacturing includes the dedication of one of our cGMP production lines and a team of chemists to each individual product. We have found this eliminates any chance of cross contamination, it keeps the manufacturing team focused on the specific project at hand and eases concerns of various regulatory agencies.
We also supply our customers with all GMP related documentation including Batch Production Records, raw material C of A’s and final QC data. CSBio will provide the appropriate documentation that may be required for preparing regulatory product submissions, such as a Drug Master File, upon request. Our value added services include process development, scale up production, analytical/process validation, stability studies, CMC, DMF, and regulatory support. It is imperative for us to work with our customers as closely as possible. We have undergone audits by many of our customers and we would certainly welcome any members of your staff to visit our facility for an audit/inspection. Should you wish to receive more information regarding our cGMP production capabilities such as overviews of recent projects, quality assurance information or contact information for references, please Contact Us.