Projects / Programmes
Isolation of large biomolecules and nanoparticles
January 1, 2013
- December 31, 2016
| Code |
Science |
Field |
Subfield |
| 4.06.06 |
Biotechnical sciences |
Biotechnology |
Finishing processes in biotechnology |
| 2.04.00 |
Engineering sciences and technologies |
Materials science and technology |
|
| Code |
Science |
Field |
| T490 |
Technological sciences |
Biotechnology |
| Code |
Science |
Field |
| 2.09 |
Engineering and Technology |
Industrial biotechnology |
| 2.05 |
Engineering and Technology |
Materials engineering |
Researchers (20)
Organisations (1)
Abstract
The development of novel biological drugs – drugs that are made of biological complex molecules like proteins, plasmid DNA and virus particles is today one of the fastest growing segments in the (bio)pharmaceutical world. Today, more and more of new potential drugs that enter into preclinical and clinical phase studies are based on biopharmaceuticals. Isoaltion and purification of these molecules out of complex mixtures to the point when they are pure enough to be used with humans, is considered as a very demanding process. New technologies are needed to complete this task. Technologies on various fields from the isolation and purification of the biomolecule, for the filling and packing of the drugs as well as in the field of molecule characterization throughout the process. Within the research programme we will be developing and optimizing novel purification processes of these drug candidates. First, the processes will be developed on a small – laboratory scale and later on transferred to a larger scale by applying and considering chemico-physical and chemical engineering principles. In paralel, novel analytical methods that will be based on new monolithic analytical columns will be developed. These new methods will be used for fast and accurate in-process and final control of various process fractions. This will allow for a faster and more timely control of the process as compared to the existing time and labour consuming biological methods. To make monolith technology even more competing and appropriate for the isolation of large biomolecules, a dedicated research and development on the monolith itself will be carried out. This will be mainly oriented and focused on the hidrofilization of the monolith surface and on the increase of the specific surface (by applying so called grafting). This will improve the monolith selectivity as well as the dynamic binding capacity for binding various biomolecules. By this, monoliths will also be more efficient in the field of cells separation. In addition to biological drugs, stem cells with a potential use in tissue engineering, cellular therapies and regenerative medicine are subjects of intensive studies in last years. In practice, the current methods for stem cells separation and purification are too expensive for use on an industrial scale. Therefore, new technologies are needed. Monolith chromatography technology is one of these potential technologies and it will be thoroughly studied and developed within the frame of the research programme.
Significance for science
In the world of large biomolecules the use of chromatography and thus the use of monolithic supports are still less well-known, mainly because these researchers are not chemists, being well aware of the effectiveness of this separation technique. The awareness of usefulness and excellence of chromatographic methods for biotechnological applications are increased through scientific publications on the chromatographic applications as well as on structural studies of monolithic chromatographic columns. This allows new innovations in the field of gene therapies, regenerative medicine, cell therapies and other medically relevant scientific fields. Despite the orientation of the research programme into applicability there are certain contents that are scientifically very relevant. We are one of the pioneers in introducing chromatographic techniques in the field of in-process control of large biomolecules. Scientific very important is the study of the use of old chromatographic methods (sample displacement chromatography), which was proven to be very efficient in the world of molecules of the future, such as plasmid DNA purification. We are first in the world offering to the market dedicated chromatographic columns for monitoring and quantification of specific viruses. We are first in the world preparing a composite material between organic monolith and TiO2 nanoparticles and using it for enrichment of phosphorylated peptides. We have developed a platform for oriented immobilisation of antibodies to the chromatographic monoliths, which will allow us in the future purification of specific cells. We believe that with such pioneering steps other research and industrial groups are encouraged to think about the broad value of the use of chromatographic monoliths. And finally, our products and purification processes have a large added value proving that a high technological products can be developed, made and marketed in Slovenia.
Significance for the country
Company BIA Separations d.o.o. targets with development of monolithic chromatographic columns (registered trade mark CIM) into the worldwide market niches, where competitive advantages of the monolithic supports are the most pronounced. The company is worldwide accepted as a pioneer in developing monolith technology and as a leading manufacturer of monolithic chromatographic columns. Since the vast majority of new drugs is more and more based on large biomolecules and there is a lack of appropriate purification technologies, the development and production of monolithic supports is considered as one of enabling technologies and is strategically extremely important. As a nice example, the industrial production of one of the first active ingredients of gene therapy drugs, where purification is done using CIM monoliths, started last year. The development of monolithic technology allows not only the growth of the parent company, but also of Slovenian subcontractors, since certain parts of the columns, for example housings, are produced by subcontractors. Some members of the programme group are in the Scientific Committee of the International Monolith Summer School & Symposium (MSS), which takes place biennially in Portorož (see http://www.monolithevents.com). In this way, the company is responsible for higher visibility of Slovenia both in the scientific and the touristic sector. We are aware of the importance of transferring knowledge and experience to pupils and students, therefore a constant education takes place in the company. There are always few undergraduate as well as graduate students working in our laboratories for their thesis. As a consequence of the development of monolithic chromatographic columns and establishment of a company position on a global market, new company facilities were built in Ajdovščina, which during the current economic crisis have represented a textbook example for the Goriška region how to cope with the global recession.
Most important scientific results
Annual report
2013,
2014,
2015,
final report
Most important socioeconomically and culturally relevant results
Annual report
2013,
2014,
2015,
final report
