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Sistema integrado de purificación y liberación prolongada de proteínas recombinantes


Oferta Tecnológica
Una empresa inglesa está desarrollando una tecnología para producir proteínas con una vida media prolongada. La tecnología de producción encierra proteínas recombinantes nacientes dentro de cristales poliédricos y evita los problemas de estabilidad que limitan el potencial de factores de crecimiento en medicina regenerativa. Se buscan socios industriales y académicos especializados en desarrollo de proteínas terapéuticas y aplicaciones de células madre con el fin de establecer acuerdos de licencia, investigación o cooperación técnica.


An integrated system for purification and extended release of recombinant proteins
An East of England company is developing technology to manufacture proteins with a greatly extended half-life. The production technology encases nascent recombinant proteins inside polyhedral crystals. This technology eliminates issues of stability that have restricted the potential of growth factors in regenerative medicine. Industry and academia developing protein therapeutics and stem cell applications are sought for agreements including licensing, research or technical cooperation.
Growth factors are cell secreted messenger proteins which influence the growth and development of cells expressing their receptor. Recombinant growth factors are commonly used reagents for manipulating cells in culture. They are also widely used as therapeutics. Typically, a growth factor must maintain set levels of biological activity for many days or even months to generate the desired cellular response. However, growth factors are naturally labile with half-lives typically measured in hours. Consequently, when recombinant growth factors are used, frequent replenishment is required to maintain activity and achieve the required outcome. Repeated dosing is not always possible. Consequently, many growth factors with therapeutic potential in a variety of indications have failed to meet clinical trial endpoints.

An East of England company owns a platform technology with a number of proven applications around greatly improved stability of growth factors. The science underlying this technology is based on the analysis of a survival mechanism used by the Bombyx mori cytoplasmic polyhedrosis virus (CPV) which infects insects. In late stages of infection, CPV produces polyhedral protein crystals within the insect cell. These are perfectly formed, porous cubes of protein about one to five microns across. Virions become specifically encased within the pores allowing the crystal to shield them from the external environment. This results in much greater durability for the virus with an extended window of opportunity for infection of a new host.
The crystal structure of the polyhedra protein has been determined and the mechanism by which virions are targeted to the polyhedra pores has also been elucidated. Based on this work, immobilisation tags have been developed which allow any growth factor (or other protein) to be specifically addressed to, and encased within, the polyhedra. For simplicity, the polyhedron delivery system is termed as pods.
In addition to increased stability, a significant advantage of growth factor pods is the ease of purification. This is due to the distinct physical properties of the polyhedra which allow isolation of their protein cargo simply by cell lysis followed by washing. Since growth factors are not denatured in the process, no refolding steps are required to isolate functional, bioactive product.
To date, the technology has been used to generate eleven different growth factor pods. Compared with standard growth factors, growth factor pods have higher stability in storage and an extended half-life in use. For example, leukemia inhibitory factor (LIF) pods can be stored at 25°C for several months and maintain >50% peak levels in cell culture after 5 days. In contrast, standard LIF is more than 95% depleted after 5 days in culture. In small and large animal models of bone repair, growth factor pods have also demonstrated their therapeutic potential. For example, bone morphogenetic protein BMP-2 generates significantly better bone growth than standard BMP-2 and activity is retained for over 10 weeks. Growth factor pods remove the need for cold supply chains and allow innovative applications of growth factors in 3D.
Advantages and Innovations:
The polyhedron delivery system alters the entire production process and the stability profile for growth factors. It is different by means of:
- Ease of purification. Since the present technology allows purification of intact, folded growth factors, it offers a simple way to make any growth factor;

- Storage. Growth factor pods show much higher levels of stability in long term storage. This is particularly important for potential therapeutic use.

- Presentation to cells. Growth factor pods form discrete units which can be incorporated into a surface and stored for long periods of time at room temperature. 2D surfaces and 3D matrices can be uniquely functionalised, for example, in cellular perfusion systems ("organs on a chip").

- Novel excipient. Many growth factor therapies have been developed for indications which can be readily administered intravenously or topically. However, indications such as neurodegenerative disease or bone fracture require invasive application which can't practically be repeated. Growth factor pods provide the ability to deliver bioactivity over a period of months. This is significantly longer than can be achieved with other passive technologies. The utility of this approach has already been shown in both small and large animal models of bone repair where it has been demonstrated that the pods persist for >10 weeks. Diseases in which growth factor pods can be expected to make a significant difference include Parkinson's, Lou Gehrig's Disease (ALS), cardiovascular disease, bone and cartilage repair. These are targets where animal models have already indicated therapeutic potential of growth factors, but subsequent clinical trials have failed to meet clinically significant endpoints.

- Ease of purification and controlled release over a prolonged period may mean further applications, for example, immunisation and immunotherapy.
Stage of Development:
Available for demonstration
Patents granted

Partner sought

Type and Role of Partner Sought:
- Type of partner sought: industry and academia.
- Specific area of activity of the partner: product development in growth factors and biologics delivery, stents, artificial organs. The end applications may be both veterinary or medical.
- Task to be performed by the partner sought: the UK company is open to various types of agreements including licensing, research or technical cooperation.


Type and Size of Client:
Industry SME <= 10
Already Engaged in Trans-National Cooperation:
Languages Spoken:


Technology Keywords:
06002002 Biología celular y molecular
06002007 Ensayos in vitro, experimentos
06002004 Ingeniería de proteínas