Since the establishment of the therapeutic relevance of insulin in the early 1920s, peptide therapeutics have come a long way.
Presently, there are over 60 peptide-based drugs available in the market. Specifically, these products represent one of the earliest classes of biologics and have, so far, demonstrated significant potential in the treatment of a variety of metabolic and oncological disorders.
Examples of popular, marketed therapeutic peptides include Victoza, LUPRON DEPOT, Zoladex, Sandostatin and Somatuline.
Further, according to experts, more than 600 pharmacological leads based on peptides are currently being investigated across various phases of development.
Owing to their proven pharmacological value and favorable safety profiles, the demand for peptide drugs is on the rise.
As a result, there is increasing interest in manufacturing solutions for large quantities of such molecules, often requiring complex manipulations of long macromolecular structures, chemical modifications and thorough purification, for both clinical and basic research applications.
Although a lot has been achieved in terms of improvements in peptide synthesis and purification methods, there are certain challenges, especially those related to large-scale manufacturing capabilities, which continue to plague drug developers in this domain.
Additionally, there are certain technical complications related to the synthesis of complex, long chain macromolecules, which are known to compromise both product yield and purity.
In order to optimize production processes and associated expenses, leverage superior expertise and infrastructure, and expedite time to market, many innovator companies have demonstrated the preference to work with specialty service providers.
Presently, there are a number of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that offer elaborate portfolios of services focused on peptide design, manufacturing and purification.
Given the historical and prevalent trends in demand for peptide synthesis and purification services, several CMOs/CDMOs are actively expanding their capabilities and capacity to ensure consistent supply.
We are led to believe that sponsor companies are likely to continue relying on contract manufacturing service providers over the coming decade.
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