Synthesis of therapeutic peptides via microbial fermentation with recombinant DNA technology
Giorgio Bertolini of Olon introduces a new biological approach to peptide manufacture
In just the last five years , the FDA has approved no fewer than 14 peptides with therapeutic activities . Today , there are around 70 therapeutic peptides under development , of which 15 are in Phase III . Many are in therapeutic areas which are seeing the most intensive R & D , including oncology , diabetes , and cardiovascular and auto-immune diseases ( Figure 1 ).
The key contributor to this success is the potent , specific and safe mode of action of peptides . The market was valued at $ 25 billion in 2019 and is projected to reach $ 50 billion by 2027 , with an expected compound annual growth rate of 9.2 % from 2020 to 2027 ( Figure 2 ).
Peptides are an extremely promising area of pharmacological research , partly because their chemical synthesis cycle offers important advantages for the industry : a short production cycle , short development times and easily scalable production for short peptides .
However , these benefits must be weighed against significant disadvantages . This is a process with an extremely high environmental impact ( just consider that it takes around 6.5 tonnes of solvents to produce 1 kg of 30 aminoacid peptides ), the use of very expensive materials and a complex impurity profile .
In addition to the chemical synthetic approaches for the manufacturing of peptide-based APIs , including classic
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Figure 1 – Peptide APIs in development by therapeutic indication
solution-phase chemistry , solid-phase synthesis , fragment condensation and other novel technologies , interest in biological approaches to producing peptide APIs is growing constantly .
Olon has been developing a new technological platform , capable not only of overcoming the disadvantages of chemical synthesis but also of offering extremely high-quality peptides , based on its extensive expertise in the field of biomanufacturing .
We began the project by working to the design of a recombinant bacterial strain capable of producing high concentrations of peptides . The platform is based on the use of a fusion protein , thanks to which we can purify the peptides in a highly efficient manner , obtaining an extremely highquality product up to 99 % purity .
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Cancer Metabolic disorder Haematological disorder Immunoligical disorder Genetic disorder Hormonal disorder Bone disorder Cardiac disorder Infectious disease Respiratory disorder Neurological disorder Adjunctntherapy Eye disorder Malabsorpion disorder
The technology provides complex recombinant peptides with high efficiency , repeatability and purity , plus a high level of consistency . Specifically designed strains provide a solid platform and starting point for high yields . Furthermore , the recombinant peptide package provides a costeffective approach for large-scale peptide production .
Advantages of recombinant technology
The recombinant production of peptides offers several advantages in terms of cost-effectiveness , scalability and sustainability . First is the high success rate of largescale production , because the biotechnological process can be easily scaled up , the raw peptides obtained are about 90 % pure and
30 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981