Peptides are an emerging class of drugs, somewhere between a small molecule and a biologic. Their synthesis can be complex, which creates various challenges in large-scale production and purification. There are a number of companies involved in peptide manufacture and at least 150 peptide projects in the preclinical or Phase I stage.
Key issues in peptide synthesis and manufacture are the number of amino acids in the peptide chain and whether synthesis is done using solution-phase (conventional chemistry) methods, solid-phase (resin-based) techniques, or a combination of the two.
“Big pharma is now interested in peptides, which are being perceived as being more user friendly and more readily available,” remarks Satish Joshi, Ph.D., evp of Solvay Peptisyntha (www.peptisyntha.com). After their relative lack of success with small molecules, companies see peptides as being more natural, which could be a big plus.
Solvay Peptisyntha originally specialized in solution-phase peptide synthesis. By 2001, the company realized that solid phase was becoming more prominent so it decided to develop that too. Solvay Peptisyntha is now in the process of enhancing its QC/QA and will expand its manufacturing as more peptides reach Phase II and Phase III.
Mimotopes (www.mimotopes.com) is one of the original peptide companies. It specializes in the supply of peptides for research and preclinical work to both academic and pharma customers. The firm creates peptide libraries for mapping antigen-binding sites or protein-protein interactions using its SynPhase Lanterns synthesis platform.
This approach, says Mimotopes CEO, Nick Ede, Ph.D., allows peptide synthesis at a higher purity than with more traditional resins. “We have developed new surfaces specifically designed for peptide synthesis, especially longer peptides with more than 25 amino acid residues.”
Mimotopes has traditionally worked at the discovery end. About two years ago, the firm identified a need at the larger-scale, value-added end of the business. “We decided to form a global peptide alliance with Genzyme Pharmaceuticals (www.genzymepharmaceuticals.com), which is one of the top five GMP manufacturers, and so become a one-stop shop for researchers to access peptide experts from research to commercialization,” Dr. Ede explains. “This alliance brings together two players with core expertise at either end of the development spectrum, each sharing its sweet spot to give peptide researchers and developers support.”