Periodic Reporting for period 2 - IcoCell (Cell line development platform for SMEs to reduce the length and cost of biologic drug development)
Reporting period: 2017-05-01 to 2018-08-31
Icosagen Cell Factory (ICF) develops a platform for more rational, efficient and cost-effective development of mammalian cell lines for high-yield protein production. This platform utilizes cell lines with predefined integration sites at the most transcriptionally active genomic loci. By predefining the integration sites, more than 10x less clones have to be analysed to find cell line with high levels of recombinant protein production compared to the current random screening. In addition, initialization of the specific recombination-dependent integration of the expression unit and amplification of the recombinant DNA reduce additionally the need for the screening of large number of clones. The platform reduces the need for robotic systems and high-throughput screening facilities, while reducing also the time required for cell line development from 6-12 months to less than 3 months.
Advances in cell line development technologies are crucial to support the rapid development of biologics, where improvements in the timeline and the ease of generating high producing cell lines can contribute to the faster development of biosimilars and innovator products alike. Market introduction of the IcoCell technology is expected to result in better health outcomes through better availability of biologics, and cost reduction for healthcare systems.
The objective of the IcoCell project was to optimize and validate the IcoCell technology for market introduction. Successful implementation of the project was expected to allow ICF to significantly increase the coverage of the needs of the customers who are developing therapeutic proteins. In addition to assisting them in pre-clinical phase, ICF would be able to help the customers to enter into the clinical phase of the drug development, and start serving more attractive and profitable client segments.
According to our best knowledge, a few biotechnology companies have started developing technologies to address the same market gap, indicating the relevancy of the challenge and existence of the business opportunity. However, all these alternative technologies are still in a very early stage of development, meaning that market introduction of the IcoCell technology in the near future as planned has still the same socio-economic impacts as expected. So far, the main societal implication of the project is the increase of awareness about the IcoCell technology and the addressed challenge among relevant stakeholders and the general public. The expected wider socio-economic impacts of the IcoCell technology are already arising as we have signed the first contract for cell line development.