// September 03, 2014

Ensuring the Quality of Synthetic Peptides

The global pharmaceutical landscape continues to evolve

Once dominated by small molecule drugs made by chemical synthesis routes, the pharmaceutical industry is more focused than ever on the class of therapeutics called “biologics”. Based on living organisms, biologic molecules are significantly larger in structure than chemical drugs.

Most biologics are also proteins—that is, their fundamental structure consists of amino acid molecules strung together to form what’s known as a “peptide”. These peptides then fold into three-dimensional shapes, and it’s this structure that gives a protein its function as a drug.

But what about those peptides whose structures fall right “in the middle”? It’s a logical conclusion that if synthetic drugs made of small molecules and biologics based on large molecules are both capable of exerting clinical effects, why can’t peptides?

Synthetic Peptides of the Past

Several decades ago, manufacturers began to explore synthetic peptides as possible drug candidates. However, they found it difficult to synthesize peptides that didn’t encounter stability issues and also didn’t quickly metabolize in the body.

In addition, most synthetic peptides could not be administered in ways other than by infusion, making them less popular for use in healthcare settings.

Synthetic Peptides Today

With technological advances over time, drug makers were been able to overcome challenges associated with the metabolism of synthetic peptides. Also, with the growing use and acceptability of infusions as drug delivery vehicles—especially for more modern biologics—manufacturers began to look at synthetic peptides with renewed interest.

Couple these factors with the dwindling pipeline of small molecule drug candidates and the large manufacturing costs associated with making modern biologics, synthetic peptides continue to provide interesting opportunities for pharmaceutical makers.

The Quality of Synthetic Peptides

Today, peptides represent one of the fastest growing segments in the pharmaceutical market. In addition, generic versions of peptides represent 35% of the peptide market, with three of the five top selling peptides being generics.

Being able to manufacture peptides that are consistent in makeup and quality is an important priority for manufacturers of this drug class. In 2013, USP established an Expert Panel on Therapeutic Peptides, tasked with tackling important issues related to peptide quality standards.

Convening the right experts around the table to inform the creation of medicine quality standards has been one of USP’s core strengths since its formation in 1820. Because of its status as an independent organization, USP is able to host dialogues about the science that undergirds product quality. These discussions engage multiple stakeholders—which often include commercial competitors—invested in the development of quality standards.

Strengthening a Market Through Public Standards

Peptide manufacturers are seeking tools that help bring consistency to the quality of their products and the raw materials used in their manufacture. At USP, peptide experts from industry have come together to discuss quality issues and are actively contributing to the creation of good quality standards that support peptide drugs.

As the global pharmaceutical landscape continues to transform and as manufacturers explore different sources for viable product candidates, public quality standards will play a growing role in the manufacture of these drugs.

To find out more about USP’s October 2014 workshop on synthetic therapeutic peptide quality and to access white papers published in Pharmaceutical Technology by the USP Therapeutic Peptides Expert Panel, visit http://uspgo.to/synthetic-peptides-workshop.

Anita Szajek, Ph.D., is a principal scientific liaison in biologics and biotechnology at USP.