PEPTIDES & PROTEINS
40,490
Figure 2
41,750
44,240
48,251
53,380
59,565
65,303
72,707
2020 2021 2022 2023 2024 2025 2026 2027
■ Including insulin
21,744
23,577
■ Excluding insulin
26,558
30,722
35,919
42,174
47,964
54,506
2020 2021 2022 2023 2024 2025 2026 2027
Figure 2 – Forecast development of peptide market (€ million ), 2020-27
a single purification step can be sufficient for a high purity product . It offers a high level of consistency and efficiency for complex peptides too .
This also represents a highly green process , considering that the solvents are required only for final product ’ s purification . Consequently , the cost impact of raw materials on overall production costs is limited to only about 5 %.
By contrast , synthetic technology used for therapeutic peptides implies several disadvantages . It has a significant impact on sustainability and environmental impact , because of the higher quantity of solvents used and the raw material cost impact on overall production costs is about 30-40 %. Regarding product quality , the risk of generating complex impurity profile ( insertion , deletion , double
hits ) is higher with chemical synthesis . As the number of amino acid forming the peptide increases , the API purity obtained is reduced . Finally the purification step of the synthesis is more complex than recombinant technology .
Olon technology rDNA technology has greatly increased the number of the industrial biotechnological applications . The microorganism is no longer used for its intrinsic capacity to synthesise a product of interest ; instead , it represents a microbial cell factory that it is used to produce heterologous proteins . This approach can open endless opportunities of application in a wide range of substance categories , as humans , plants , animals and many others .
Olon has applied rDNA technology to the production of therapeutic peptides , relatively small peptides analogues of human hormones with some small modifications in the structure to improve their stability .
The choice of the expression system plays a central role in the development of a recombinant production process . So far the production of approved therapeutic peptides is restricted to E . coli , S . cerevisiae and P . pastoris . We have developed a specific expertise in E . coli as a host strain
This R & D strategy is based on multiple factors . Genetic E . coli is very well known : this strain can be easily manipulated , it has particular nutritional requirements and it has a short replication time . Using E . coli , it is possible to produce a significant quantity of recombinant proteins in a short time . Finally , scale-up for fermentation process is relatively simple and cost-effective .
Our R & D strategy is to invest in vector design along the development process . Our strategic approach , even if more complex , allows us to minimise the risk of issues of instability of the recombinant peptide and simplify the product purification
The company also has internal expertise in scaling up peptides to major industrial scale . We developed a production method that was optimised to encounter the requirements of regulatory agencies that have set very low allowable limits .
The strategy was to develop a platform that could make it possible to produce easily different peptides with a reproducible process that can eliminate efficiently the host cell-related Impurities during the downstream process and minimise immunogenicity risks . ●
Sabrina Spina
MEDIA & COMMUNICATION ASSOCIATE DIRECTOR
OLON SPA k + 39 338 6674289 J sspina @ olonspa . it j www . olonspa . com
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