Our pharmaceutical-grade peptides are manufactured with materials of the highest quality purchased by qualified vendors and evaluated by our quality assurance department. The peptides are synthesized and the final drug substance is subjected to a battery of analytical tests using validated methods in the quality control department. This thorough process results in assurance of consistent, reliable, and timely supply of ultra-pure pharmaceutical grade peptides.
Manufacturing in accordance to current good manufacturing practice (cGMP) is crucial in producing these high-purity, quality pharmaceutical grade peptides. Compliance with cGMP means manufacturing is performed under strict adherence to FDA regulations 21 CFR parts 210 and 211 in addition to meticulous documentation and following standard operating procedures. Complete documentations and regulatory support is also provided for customers’ Investigational New Drug (IND) and New Drug Application (NDA) submissions.
To produce pharmaceutical grade peptides manufactured under cGMP, it is important to have extensive experience in synthesizing pharmaceutical grade peptides for therapeutic and diagnostic applications. This experience can help manage resources and advance a peptide-based product to market quickly. American Peptide Company (APC) has provided active pharmaceutical ingredients for applications worldwide for over ten years.
American Peptide Company is able to leverage its experience to dedicate significant resources to support research in solid and solution-phase technologies, difficult or unusual sequences, validation of manufacturing process and analytical methods, and much more. These capabilities allow us to supply generic peptides as well as peptides and related products for therapeutic and diagnostic studies in HIV, osteoporosis, diabetes, Alzheimer’s, and many other human diseases.