Ask the Expert
Q & A: Peptides and Good Manufacturing Practices (GMPs)
The Peptide Wire speaks with American Peptide Company's resident experts, Patricia K. Haller, Ph.D., Director, GMP Production and Process Development and J. J. Jiang, Ph.D., VP of GMP Manufacturing on best practices in peptide GMP manufacturing.
PW: Is APC’s approach to GMP different from its competitors?
PH: We see ourselves not merely as peptide manufacturers, but as strategic consulting partners to our customers. For this reason, we have developed a comprehensive program under the ‘Total Peptide Management’ banner. Total Peptide Management is a customized service platform that features a broad portfolio of peptides, value-added services, and expert consultation to support customer needs as their drug products move from discovery to development and commercialization.
The program facilitates greater adherence to cGMP standards and protocols. It mandates application of cGMP practices to even non-GMP applications in the early phases of drug development to provide drug researchers with manufacturing processes that can be scaled up efficiently. Partnering with our customers from discovery through commercialization streamlines the drug development and manufacturing process. This speeds drugs to market and ultimately enhances profitability for our customers.
PW: Tell us a little bit about your GMP process?
JJ: Every product manufactured under cGMP undergoes a battery of analytical tests. Each batch is provided with a lot-specific GMP certificate of analysis (COA) documenting specifications, test methods and results. We also provide complete documentation and regulatory support for our customer’s Investigational New Drug (IND) Applications and New Drug Application (NDA) submissions. Additionally, we provide regulatory documentation for Chemistry, Manufacturing, and Controls (CMC) and Drug Master Files (DMF) to our customers.
PW: You talked about documentation. Why is it so important?
JJ: Generally speaking, documentation of the manufacturing process along with all related in-process and final release testing is essential to maintaining compliance with regulatory oversight. This involves maintaining extensive records of production, change control, vendor audits and qualification process and the raw materials testing and release.
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