Peptide drugs are increasingly complex and require challenging modifications, such as incorporating unnatural amino acids or being linked to carrier molecules to enhance drug delivery and efficacy. Although peptides have tremendous therapeutic potential, they often are difficult to synthesize and retain activity.
The scientists at American Peptide reportedly excel at PEGylation technology, which attaches chains of polyethylene glycol (PEG) to improve drug performance. The benefits of PEGylation include decreased immunogenicity, increased half-life in vivo, and reduced renal clearance.
PEG can also act as a repellent to prevent bacteria from contaminating medical implants and catheters. Grafting PEG to plastics and metals is challenging and requires linking it to hydrophobic molecules. “We have good expertise at making hydrophobic peptides,” says Shakoori. These peptides contain high concentrations of hydrophobic amino acids, such as leucine, isoleucine, and alanine, which are insoluble and hard to purify.
Clients come to American Peptide in various stages of the drug development process, but most are in Phase I and II. They receive help with stability, solubility, degradation, and impurity issues. Other services include process development, scale-up production, analytical and process validation, stability studies, and regulatory support. As genome mapping information increases, clients are able to find and develop specific peptides that target a variety of diseases.
Custom and catalog peptides make up about 40% of the company’s business, and cGMP and API manufacturing form the other 60%. The cGMP business is thriving and expected to grow even more as more peptide therapeutics advance through Phase II and III trials. American Peptide works with customers to validate lots, submit a drug master file, and eventually make the drug after FDA approval.
American Peptide takes pride in making all components of its cGMP peptides in-house. “All of the small-to-large scale and solid-phase to solution-phase processes are done under the same roof at Vista,” says Shakoori.
Although, some peptide manufacturers contract out stages of production to Chinese or European facilities, keeping all activities in-house provides better quality control because the same rules apply to all steps of production, according to American Peptide.