The introduction of insulin therapy in the 1920s, for the treatment of diabetes, marked the beginning of the therapeutic use of peptides. Presently, peptide-based therapeutics represent a prominent class of therapeutic interventions. Currently, many peptide therapeutics are being developed for the treatment of oncological disorders. In fact, in 2018, about 75% of such therapeutic products were estimated to be available for the treatment of different cancer indications, accounting for global sales of more than USD 1 billion. It is worth highlighting that, till date, more than 60 peptide drugs have been approved by the United States Food and Drug Association (USFDA), while more than 400 peptides are presently being in clinical trials.
Such therapeutics, when compared to recombinant antibodies and protein-based interventions, have been shown to demonstrate better tissue / cell penetration, owing to their small size and low immunogenicity. Further, the need for advanced technologies, along with specialized equipment, have resulted in the outsourcing of the peptide production to the contract manufacturers. The contract manufacturing market in this domain features the presence of large contract manufacturing organizations (CMO), mid-sized CMO and small companies.
The table below provides the information on the key points of different processes used for synthesis of peptides.
S. No.TypeProcessesSpecifications1ChemicalLiquid phase synthesis
- Used for producing peptides with < 8 amino acids
- Easy and inexpensive scale-up
- Difficult purification
- Not highly automated
- Long production cycle
- Produces only one product
- Requires additional set-up for the protection of C-terminal of the first amino acid
2ChemicalSolid phase synthesis
- Used for producing long peptides in small quantities
- Easy purification
- Expensive purification
- Highly automated
- Short production cycle
- Extra steps are required for linkage and cleavage
3ChemicalHybrid phase synthesis
- Combination of solid and solution phase
- Initial condensation reaction between two or more suitable peptides takes place in the solid phase
- Synthesis of longer peptides (>50 amino acids)
3ChemicalMicrowave assisted technology
- More effective for the synthesis of difficult-to synthesize peptides
- Better peptide yield and purity
- Better reproducibility
- Faster reaction times
- High chances of racemization and dehydration
- More effective for the synthesis of long peptides
- Uses chemical and enzyme-mediated technologies
- High yield
- Better chemo selectivity
- Used for producing immunogenic or biologically active peptides
- Easy introduction of unnatural amino acids
- More complicated solubility
Source: Roots Analysis
A contract manufacturer is a third-party organization that offers manufacturing related services on a contract basis to other firms. Typically, a client may approach a contract manufacturing firm after conducting initial R&D for a product and employ its services to manufacture the product, usually at larger scales.
The in-house development of peptide API requires necessary expertise and capabilities, including design, construction and maintenance of a facility which demands significant capital investments. Therefore, several small drug developers and, at times, certain pharma giants as well, have begun outsourcing their manufacturing operations to contract service providers. The increasing demand for companies capable of offering manufacturing and, in certain cases, development services to biopharmaceutical players has resulted in the establishment of several CMOs. Most of these contract service providers have profound experience in niche and emerging areas. The innate expertise and availability of the required capabilities and infrastructure enables CMOs to effectively fulfil the requirements of their clients, eliminate costly oversights and, thereby, reduce chances of failure.