Demand for peptide APIs is now centred on large quantities of custom-made and complex peptides, and specialist producers are seeing a window of opportunity. Word Pharmaceutical Frontiers talks to Dr Barthelemy from Peptisyntha SA about this trend.

Peptide APIs are undergoing something of a renaissance as pharmaceutical companies once again turn their attention to the therapeutic potential of such substances. This new way of thinking about peptides, which disregards previous concerns about their bioavailability, is fuelling the need to manufacture high-quality peptides in ever-greater quantities.

"We are seeing more peptide APIs on the market," says Dr Pierre Barthelemy, general manager of Solvay Peptides at Peptisyntha SA. "A few years ago, pharma companies were reluctant to work with peptides because they were seen as having low bioavailability and are rapidly degraded in the intestinal tract. Now, many companies show no hesitation in bringing peptides to clinical development."

This trend has been particularly noticeable over the last six years, partly due to the huge advances that have been made in drug delivery systems. During that time the processes used in peptide production have changed too, and the market has steadily become more competitive in the last decade.

"Customers want high-quality, cost-effective production and the ability to scale up quickly," says Barthelemy. "The cost of peptide APIs is important, but the quantities required are rising. Companies have no hesitation in touching therapeutic indications where large quantities are needed over time, even if this means a high dose for the end user."

Customised peptide formulae

In addition to cost, quality and volume requirements, there is also the matter of complexity to consider. The new trend is towards using long peptides that may be 25 to 30 amino acids in length. This means there is a greater need for specialist manufacturers that can produce large quantities of complex, custom peptides quickly and at reasonable cost.

This is where specialist manufacturers such as Peptisyntha, part of the Solvay group, see their market opportunity. As well as having considerable in-house expertise in the peptide field, the firm has its own proprietary technology, which has been developed over the last 20 years. This technology allows it to reduce the number of steps in the production process and therefore reduce cost.

"On average, we can reduce the number of steps by 20-30 per cent, though this depends on the individual sequence," explains Barthelemy. Furthermore, it is one of a relatively small number of companies that can produce large quantities of peptides quickly and efficiently.

"We are a custom peptide producer," says Barthelemy. "Pharma and biotech companies come to us with a product in development, and they have peptides that they want to bring to clinical trials but do not want to produce in-house. They give us their formula and we develop the production process, then scale it up. We do this specifically for each customer."

Because individual peptide formulae are important pieces of intellectual capital for drug development companies, a close relationship between these firms and their peptide producers is extremely important. "In the last five years, we have seen our pipeline of projects fill dramatically," says Barthelemy. Peptide API producers, in general, have a good line of projects, but the question is, do they have the right ones?"

For peptide producers, the challenge is to pick projects where indications suggest that a successful drug can be marketed, so that they can play their part in the eventual final phase of production. For drug developers, the challenge is to choose a peptide producer that can meet its production requirements at a reasonable cost.

With peptide API use continuing to grow, the next five years will be critical for both producers and drug developers.