RESEARCH ACTIVITY
Pharmacy and Biotechnology Center
Pharmacy, Cosmetic Chemistry and Biotechnology RESEARCH GROUP
Area Leader
Jolanta Janiszewska, PhD Sc. Eng.
phone +48 517 883 174
jolanta.janiszewska@ichp.lukasiewicz.gov.pl
- Cosmetics and household chemicals
- Advanced functional materials – medical devices, food supplements, pharmaceuticals, nutraceuticals
- Use of bioprocesses in chemical technology
- Biologically active substances for the life science industry
- Biologically active peptides – protein hydrolysates, synthetic peptides
The Formulation Technologies Section deals with the development of formulations and manufacturing technologies for medicinal products, medical devices, dietary supplements and foodstuffs for special medical purposes.
The team consists of specialists with many years of experience in conducting research and development projects, confirmed by numerous technology implementations at home and abroad.
State-of-the-art technological facilities (modernisation in 2019) ensure the highest manufacturing standards in line with EMA and FDA guidelines. The technology park enables the manufacture of solid forms of investigational medicinal products for clinical trials, including:
- Short series for rare, orphan diseases
- Standard batches for common diseases
- Formulations for bioequivalence studies
- Formulations for pre-clinical studies
Two key areas of research are pursued in the Chemistry Section:
- development of innovative technologies for active substances of generic drugs on laboratory and large-scale non-GMP laboratory scale, allowing successive scaling up of processes of manufacturing pharmaceutical substances up to semi-technical scale,
- scientific research into the search for new compounds possessing biological activity in cooperation with leading academic centres at home and abroad.
- Cloning of DNA fragments and construction of prokaryotic production strains
- Strain stability control, preparation and maintenance of Research Cell Bank (RCB) and Master Cell Bank (MCB) and Working Cell Bank (WCB)
- Microbial culture / Upstream production
- Purification of recombinant proteins / Downstream production
- Lyophilisation
- Protein identification and molecular weight determination
- Genetic engineering
- Molecular modelling
- Protein engineering
- Other services
Pharmaceutical Analysis LABORATORY
The Quality Control Section carries out analyses in the field of control:
- starting materials used in the manufacture of active substances and medicinal products
- intermediates manufactured in the production process (in-process testing)
- final products – active substances
- medicinal products
- packaging materials in which active substances are stored
- manufacturing conditions, including cleaning processes of the process apparatus according to Ph. Eur., USP, FP in accordance with GMP standard.
The Chemical Analysis Section carries out analyses of active substances, medicinal products, excipients, pharmaceutical raw materials according to Ph. Eur., USP, FP in accordance with the GMP standard.
Areas of operate
- Development and optimisation of analytical methods
- Validation of analytical methods
- Validation of methods for the determination of residues of substances in the process of cleaning the production line
- Verification of analytical
- Transfer of analytical methods
- Batch certification for GMP compliance (certificate) for quality control of medicinal products, active substances and excipients and raw materials
- Pharmaceutical availability studies for various pharmaceutical forms
- Stability testing of active substances and medicinal products in qualified climate chambers under long-term conditions
- Impurity profile testing – detection, identification and quantification of impurities according to the requirements of pharmacopoeial monographs (USP, Ph. Eur., FP), recommendations of the International Conference on Pharmacopoeia (ICIP), and the International Conference on Pharmacopoeia (ICP). Harmonisation (ICH), the requirements of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)
- Standardization of standards for active substances and their impurities.
In the Research Analytics Section, research work is carried out on the full analytical characterisation of chemicals and pharmaceuticals, as well as analytical work for various pharmaceutical forms (tablets, capsules, solutions, eye drops in solution and suspension form, emulsions and ointments). On the basis of the research conducted, documentation is prepared that meets the requirements of the committees creating quality criteria for medicines, including the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the European and US registration authorities.
The Research Analytics team cooperates with scientific and industrial units by carrying out analytical work as part of scientific projects. The results of research work are presented in national and international journals and at scientific conferences.
The Pharmacokinetics Team conducts work on bioequivalence and bioavailability studies of medicinal products. Od roku 2003 Zespół pracuje zgodnie z zasadami Dobrej Praktyki Laboratoryjnej (Certyfikat nr 25/2020/DPL). The team has performed more than 400 validations of analytical methods and pharmacokinetic studies in collaboration with national and international pharmaceutical companies and clinical centres.
Areas of operate
- Study design preparation
- Development or adaptation of a bioanalytical method for the determination of a medicinal substance and/or metabolites in biological material
- Validation of the bioanalytical method in accordance with EMA requirements
- Performance of assays in a biological material (HPLC, LC/MS/MS)
- Pharmacokinetic calculations (WinNonlin)
- Study documentation in CTD format Module 5:
- Archiving of biological material samples (≤-14°C and ≤ -60°C)
- Preparation of expert opinions
- Management of pharmacokinetic studies (including clinical part)
- Preparation of application for funding
Sekcja Analizy Mikrobiologicznej prowadzi prace w zakresie badań mikrobiologicznych dla zleceniodawców z przemysłu i w ramach kooperacji wewnętrznej Łukasiewicz- ICHP. Sekcja Analizy Mikrobiologicznej posiada certyfikat GMP i regularnie jest poddawany audytom firm zlecających badania oraz Głównej Inspekcji Farmaceutycznej. Oprócz standardowych badań w kontroli jakości, Sekcja zajmuje się także opracowaniem metod badań do konkretnych produktów farmaceutycznych oraz do produktów nie będących lekami.
Areas of operate
- sterility testing
- microbiological purity testing
- testing of bacterial endotoxins (gel method: limit test)
- antimicrobial efficacy testing
- effectiveness of disinfectants
- microbiological monitoring of clean rooms
- testing of the fertility and sterility of microbiological media
- validation and transfer of microbiological methods – confirmation of the suitability of a method for a given application.
SUSTAINABLE CHEMISTRY CENTER
Polymer Technology RESEARCH GROUP
Area Leader
Piotr Jankowski, PhD Sc. Eng.
phone +48 453 056 197
piotr.jankowski@ichp.lukasiewicz.gov.pl
Research topics
- Chemical modification of thermoplastics by reactive extrusion
- Recycling of thermoplastics, including by reactive extrusion
- Filling and reinforcement of thermoplastics
- Biodegradable polymer composites using raw materials of natural origin
- Polymer nanocomposites
- Modification and processing of engineering plastics, including PPO
- Investigations into the properties of polymeric materials
- Manufacturing technology and modification of polymeric materials
Research topics
- Research into the flame retardancy of plastics (polyethylene, polypropylene, polyurethanes, polyesters, epoxies, polystyrene and others).
- Synthesis and modification of halogen-free flame retardants, including Intumescent Flame Retardant System (IFRs), synthesis of flame retardants based on epoxy resin technology.
- Selection of flame retardants that work effectively in a composition with a given plastic.
- Technologies for obtaining polyester resins, epoxy resins – including resins with special properties, liquid, low-melt, solid epoxy resins, elasticising agents for epoxy resins.
- Technologies for obtaining composites including nanocomposites based on duroplastics.
- Synthesis of auxiliaries for selected engineering resins – including plasticisers derived from by-products and waste products
- Technologies for urea, melamine, phenol-formaldehyde resins – including melamine foams and formaldehyde-reduced resins.
- Technologies for polyurethane plastics – new types of insulation materials (modular construction), flexible polyurethane foams.
- Waterborne polyester resin technologies.
- Optimization of existing technologies related to the above.
- New polymeric materials: chemical and physico-chemical modification of thermo- and duroplastics.
- New polymeric materials: functional polymers with the addition of structure modifiers or functionalized hybrid natural or waste fillers.
- Thermoplastic, solvent-free hot-melt adhesives: polycondensation adhesives (polyamide, polyester), adhesives based on PP, PE, EVA copolymers, APAO and block rubbers (SIS, SBS, SEBS) and others, adhesives used in the following industries: leather, electrical engineering, construction furniture, packaging and electronics.
Research topics
- Design of new biopolymers with competitive antimicrobial, antifungal and antioxidant properties
- Modification of the physicochemical and functional properties of biodegradable natural polymers (especially chitosan) with potential application in the packaging industry
- Preparation of new plasticisers for polymeric materials based on polysaccharides, including the synthesis of deep eutectic solvents
- Edible coatings and active packaging based on polymers of natural origin as competition for contemporary packaging materials used in the food industry
- Investigation into the release of active ingredients from polymer matrices
- Preparation and physicochemical characterisation of new crosslinking agents and polymer blends and composites
- Chemical and physical crosslinking of polymer blends
- Emulsion, suspension and block polymerisation – preparation of polymer suspensions and monodisperse latexes and transparent plastics
- Purification and separation of substances (e.g. from plant material) by extraction and by sorption and desorption on ionic or non-ionic resins
- Preparation of organic fungicides and bactericides and natural fertilisers
Research topics
- Synthesis of polyurethanes and silicone-urethanes cross-linking with atmospheric moisture,
- Aqueous dispersions of polyurethanes, silicone-urethanes, acrylic-urethanes, silicone-acrylics, acrylic-alkyds, especially in application as coating materials,
- Isocyanate modification of asphaltenes, coal tar pitch and hydrocarbon resins,
- Association of polyurethane thickeners,
- Aging and application testing of adhesives, coatings, putties and compositions,
- Polymeric plasticisers for PVC,
- Solvent-free and water-dispersible binders for UV-crosslinking coatings,
- Silicone-urethanes as:
-
- living cell scaffolds,
- solid polymer electrolytes,
- membranes for the separation of liquid and gaseous mixtures,
- Polymer nanopowders as impact modifiers for powder coatings and polymer plastics,
- Coating materials for special applications, e.g. self-healing polymeric coatings, electromagnetic radiation shielding, etc,
- Reticulated glassy carbon,
- Polymeric consumables used in 3D printers.
- Studies of selected properties of coating materials (paints and varnishes).
- Synthesis, optimization and modification of vinyl and special polymers including: poly(vinyl chloride), poly(vinyl butyral), poly(phenylene oxide), poly(methylene oxide), polyacrylate
- Suspension PVC production technology – all aspects, including scaling up processes conducted in laboratory conditions to pilot and industrial scale.
- Technology for the manufacture of PVC nanocomposites produced “in-situ” – laboratory scale, pilot scale.
- Technology for the manufacture of polyacetals – large laboratory and industrial scale, physical modification, development of design assumptions for the process of manufacturing polyacetals on an industrial scale.
- Cationic copolymerisation of trioxane with various comonomers, selection of initiators.
- Selection of composition and processing conditions for PVC blends, including those containing recycled PVC.
Research work in the polymerization process of vinyl chloride (PVC synthesis)
→ strong Development of new reaction formulation compositions to improve the quality of the resulting polyvinyl chloride
→ Optimization of PVC synthesis processes towards: Increasing yields, Formulation compositions
→ Research toward developing types of PVC for new applications
→ Study of the influence of individual components of the reaction mixture on the properties of PVC
→ Study of new auxiliary substances in the PVC synthesis process and determination of their influence on the quality of the obtained PVC
→ Research toward meeting the environmental requirements of the PVC synthesis process.
Research work in the preparation of dry mix (dry-blend)
→ Development of a dry mix recipe that meets specific processing properties→ Development of a dry mix recipe that meets specific processing properties→ Modification of the recipe for optimization: Composition, Properties, Price→ Study of the effectiveness of new processing agents and determination of their method of use (quantity, stage of introduction into the mix) on the properties of the finished product and the processing process→ Quality testing of PVC blends.
Processing studies
Chemical Technology RESEARCH GROUP
Research topics
- Large organic synthesis processes
- High pressure processes
- Identification analysis of organic compounds
- Research and development offerings
- Synthesis of ionic liquids
- Highly-processed chemicals – biocides and hygienizing agents
- Bioprocesses in chemical technology
- Separation of azeotropic mixtures
- Desulphurisation of fuels
- Organic compound analysis
Research topics
- Studies on dehydrogenation processes of light aliphatic hydrocarbons (C3, C4)
- Studies of catalytic processes in multiphase systems under elevated pressure and temperature conditions; laboratory and semi-technical scale
- Production of synthetic fuels – Fischer-Tropsch synthesis using CO2
- Process development, design and optimisation – environmentally friendly alternative synthesis routes (laboratory to large-scale)
- Treatment of gaseous/liquid product streams
- Separation of process streams by membrane techniques.
Experience
- Industrial catalyst testing
- Thermal conversion processes (pyrolysis, cracking)
- Dehydrogenation of low molecular weight olefins
- Calculation, design and optimisation of chemical apparatus and processes
- Separation of process streams by membrane techniques.
- Fischer-Tropsch synthesis.
Research topics
- Expertises and assessments of prospective developments in chemical and petro-refinery processes
- Mechanochemical support and other methods for the intensification of industrial organic syntheses
- System solutions for oleochemistry, cascade processing of waste, forest and agricultural biomass and renewable raw materials
- Evaluations of technological concepts in the context of industrial implementation – including raw material and process integration
- Optimisation and up-scaling of petro-, biorefinery and recycling processes (following concept evaluation)
- Pyrolysis, cracking and gasification processes for waste plastics and rubber, biomass and unsorted municipal waste
- Biorefinery methods for the production of base chemicals, highly processed compounds and propellants (2nd and 3rd generation biofuels)
- Hydrogen production technologies for the chemical industry, distributed energy and electromobility
- Design, preparation and characterisation of catalysts for organic syntheses
- Enantioselective catalysts in organic synthesis processes
- Mineral and plant-derived fillers for polymer composites and refinement of recyclates
- Physicochemical analyses of catalysts, process streams and products of petro-, biorefinery and recycling processes.
Experience
- Expertise in chemical and petro- and biorefinery process development directions;
- Mechanochemical intensification of industrial chemical processes;
- Development of new, technologically attractive pathways for waste management and biomass processing, including for propellants and highly-processed compounds;
- Production of highly processed compounds from renewable raw materials (e.g. chlorophyll-based);
- Development of new, efficient catalytic systems;
- Scaling up technological processes.
Evaluation and analysis of household chemical products and raw materials:
- Detergents: evaluation of washing performance in real conditions, testing of washing ability, incrustation, decrease in tear strength, graying, yellowing, shrinkage, discoloration, maintaining whiteness, softening of washed products.
- Liquid dishwashing detergents: test of washing capacity (IKW test, direct washing test) test of fat emulsifying capacity.
- Sanitary cleaners: test of limescale-dissolving capacity.
- Cleansing milks and powders: testing of washing capacity and surface damage.
- Oxygen and chlorine bleaches: study of bleaching ability, degree of fiber damage, color discoloration, yellowing.
- Fabric softeners: testing the softening effect, elimination of static electricity, change in whiteness of products, ability to absorb moisture.
- Glass cleaners: testing of dirt-removing capacity, dry matter, alcohol content.
- Shampoos: testing of foaming capacity.
- Analytical and physico-chemical testing of raw materials and finished products.
Tests for ultimate biodegradation of organic compounds including detergents
- Tests for ultimate biodegradation by manometric respirometry
- Investigations on ultimate biodegradation by measurement of dissolved organic carbon loss (DOC)
- Determination of chemical oxygen consumption (COD)
- Determination of dissolved organic carbon (DOC)
Research topics
- Hydrometallurgy and electrometallurgy of non-ferrous metals
- Recovery of metals and valuable elements from products and industrial wastes
- Technologies for obtaining nanometals for industrial applications
- Treatment of industrial and waste electrolytes from metallic impurities
- Application of new electrode materials in cells, batteries and supercapacitors
- Low-temperature polymer electrolyte fuel cells – cell construction and testing
- Research into electrocatalysis and the mechanism and kinetics of selected electrode processes
- Disposal and recycling of batteries and accumulators
- Polymer composites with metallic fillers
- Investigation of the properties and analysis of materials using modern physico-chemical methods (SEM, PCS)
- Determination of metal content in aqueous solutions and in organic, inorganic and mixed-matrix organic-inorganic samples (after dissolution/mineralisation of samples)
Experience
- Preparation of electrodes and conduct of electrode reactions relevant to electrochemical energy sources
- Construction and testing of batteries and cells
- Construction of efficient energy fuel cells of the DMFC and H2-PEFC types
- Construction and design of electrochemical test benches
- Investigations in the field of electrochemical processes of separation of metals and their compounds on various substrates (RVC®, GC, Pt, Au, Fe, Pb, PbO2, graphite, ultramicroelectrodes)
- Research in the field of purification of waste electrolytes from metallic impurities
- Development of a technology for obtaining copper powders and nanopowders
- Development of a method for obtaining polymer composites with copper nanopowders for use in shielding electromagnetic radiation
