Competences and research directions
-Improving the bioproductiv potential of the microorganisms from our own collection by applying genetic modification techniques ;
- Development of biosynthesis processes with highly producing microorganisms applying modern bioengineering methods (automated, computerized process control, separations and purifications through semipermeable membranes etc.) for the obtainment of bioactive products (pharmaceutical and industrial enzymes, nutritional supplements – nutraceutics, biostimulators, biofertilizers), biomaterials (biopolymers – vehicules for active therapeutic substances or formula and controlled release adjuvants)
- Drawing up some unconventional procedures for the sustainable development and pollution reducing (for example: biotransformations, bioconversions, for the obtainement of some biofuels), which can be made by introducing the recombinant microorganisms and new enzymatic technologies (in nonaqueous media), leading to selective biotransformations that replace chemical synthesis; previous accomplishemnets of the institute in external cooperation and the poor international experience creates new affirmation opportunities.
- Research oriented according to the existing directions at global research (for example antioxidands) or to our own progresses (antiulcerous, antiinflamatories), as well as to the known structure-activity relationships;
Bioactive substances synthesis
- Establishing a more efficient pharmacological testing system for specific and toxicologic action by extending the determinations at cellular level and national and international cooperations;
- Determining the purity and structure of the isolated target compounds;
- Applying some synthesis and/or formulation techniques to natural products, verifying their effects on activity and biodisponibility in vitro and in vivo.
In order to obtain bioactive substances through chemical synthesis, two main directions are maintenaded: innovative products and generic technologies.
Innovative drug substances are new chemical entities with high chances of becoming compounds of therapeutic interest, the effort for their research being concentrated in therapeutic directions prioritary at European and global level: degenerative chronic diseases (metabolic: diabetes-obesity, of the central nervous system: Alzheimer), cancer, viral infections, tuberculosis.
For accomplishing this, the directions are:
- introducing and extending computer assisted drug design techniques (drug design computational) through:
- therapeutic targets (ligand based drug design);
- structure-activity relationships (SAR, QSAR);
- virtual design (virtual library design).
- perfectioning preliminary pharmacological screening throught cellular and molecular biological models.
- extending and enforcing internal and external partnerships with academic and universitary reseach (including European, throught projects at Technological Initiative “Innovation drugs”).
- complex selective synthesis of natural and/or modified, potentially therapeutical substances (for example: antiviral nucleosides, immunostimulative polysaccharides, antitumoral, chiral molecule, potentially active).
The technologies for generic products target the obtainment of competitive synthesis technologies of some complex substances (for example: natural, cell regulatory) with high therapeutic and market value, as well as the development of technological improvment favourising environmental protection and sustainable development, by replacing some synthesis steps that imply conventional resources and pollutive processes with bioprocesses or bioproducts (sustainable, “white” chemistry).
The R-D activity in the field is oriented towards new formulation techniques and new material applications (preferable bio-), having as present direction, of high interest, the optimization of biodisponibility through pharmaceutical formulations with controlled delivery of the active ingredient and through the development of micro- and nano-particules systems as transport vehicules for the active substance to the target, like for example:
- obtaing some liquid and semi-liquid pharmaceutical forms for local administration (transdermic, intra-nasal) containing micro- and nano-particules (for example: liposomes, derivatives of some biopolymers) combined with penetration promoters, transporting highly active substances to the target, in small dosages (for example: hormones, hypertensives, anesthesics, vaccines).
- as formulation agents, biopolymers from the internal R-D activity (biotechnologies) are preferred.
It is achieved in the department of Physical-Chemical Analysis and Quality Control (GLP authorized by the National Medicines Agency) through:
- applying high performance analytical techniques: column liquid and high performance thin layer chromatography, coupled with mass spectrometry (HPLC-HPTLC-MS), gas chromatography with computerised data registration and interpretation, automated elementary analysis, UV, IR spectrometry (with Fourrier series), atomic absorbtion; dissolution and desagregation tests under standard contitions (qualified equipments)
- elaboration of specific analysis methods and their validation;.
- quality control according to the European, British, USA and international pharmacopaea (harmonized) for the complete composition and purity characterization of the natural products (biotechological);
- verifying the structure and purity of synthesis substances;
- determining the formulated drugs in vitro stability and biodisponibility (dosed form);
- raw materials, packaging materials and drugs quality control according to the European and international regulations.
It is oriented in the following directions:
- in vivo precilinical toxico-pharmacological and microbiological characterization of active products and medicines, as well as of other products that require similar testing;
- design of unconventional/alternative pharmacological testing methods;
- characterization of the pharmacodynamic and toxicologic action trought cellular and molecular methods;
- appling European regulations regarding animal pharmaco-toxicological tests and microbiologic control and their certification (accreditation);
- extention of the use of in vitro systems for toxicity assesement: organ-specific toxic action (neuro-, immuno-, hepatotoxicity), genotoxicity (on mammal cells and microorganisms), teratogenicity, local -introduction of new screening systems on cellular cultures and organ-mimetic structures; identification of biomarkers and use of molecular targets.