Bio- ja lääkintäoikeuden kehitysnäkymiä

Vuoden 2004 väittelijän palkinnon saajan puhe VII Oikeuskulttuurin päivässä 11.11.2005

Design of a Condition Monitoring System for a Glass Wool Production Line

Työn tarkoituksena oli suunnitella kunnonvalvontajärjestelmä kahdelle lasivillan tuotantolinjalle. Suunnitteluprosessin lisäksi työssä on esitelty erilaisia kunnonvalvontamenetelmiä. Työn alussa on kerrottu erilaisista kunnonvalvontamenetelmistä, joilla voidaan seurata erilaisten laitteiden ja koneiden toimintakuntoa.Erityisesti työssä on tarkasteltu teollisuudessa yleistyviä kunnonvalvonnan värähtelymittauksia. Työssä suunniteltu kunnonvalvontajärjestelmä perustuu viiteen eri menetelmään, jotka ovat värähtelymittaus, lämpötilanmittaus lämpökameralla, lämpötilanmittaus kannettavalla mittarilla, kuuntelu elektronisella stetoskoopilla ja pyörivien osien kunnontarkkailu stroboskoopilla. Kunnonvalvontajärjestelmän suunnittelu on tehty useassa eri vaiheessa. Ensin työssä on kartoitettu tuotannon kannalta tärkeimmät laitteet ja niiden mahdolliset vikaantumistavat. Seuraavaksi on valittu sopivat kunnonvalvontamenetelmät ja tehty mittaussuunnitelma, jossa on esitetty eri laitteille suoritettavat mittaukset ja mittausten aikavälit.Lopuksi työssä on esitelty muutama esimerkkitapaus kunnonvalvontamenetelmien käytöstä sekä kerrottu mahdollisista tulevaisuuden kehitysmahdollisuuksista.

Kuiva-, bio-, hyöty- ja ongelmajätteiden keskitetysti kilpailutettu kuljetusjärjestelmä Etelä-Karjalassa

Tutkimuksen tarkoituksena oli tuottaa tietoa kuiva-, bio-, hyöty- ja ongelmajätteiden keskitetysti kilpailutetun kuljetusjärjestelmän eduista ja haitoista Etelä-Karjalan Jätehuolto Oy:n alueella. Tutkimuksessa esitellään jätteenkuljetusjärjestelmien ominaisuudet ja niiden suunnittelu sekä jätehuoltoa ja jätteenkuljetuksia koskeva lainsäädäntö. Keskitetysti kilpailutettu jätteenkuljetusjärjestelmä mitoitettiin järjestelmän nykytilan kuvauksen sekä muualla Suomessa kilpailutuksesta saatujen kokemusten avulla. Järjestelmää arvioitiin vertaamalla kaluston tarvetta, kuormapainoja sekä kuljetuskustannuksia nykyiseen tilanteeseen. Lopuksi arvioitiin jatkokehitystarpeita ja tarvittavia toimenpiteitä, kun keskitettyyn kilpailuttamiseen siirrytään. Jätteenkuljetusten keskitetyllä kilpailuttamisella voidaan saavuttaa etuja nykyiseen kuntakohtaiseen jätteenkuljetukseen verrattuna. Edut syntyvät kun päällekkäiset ajot sekä siirtoajot vähenevät ja kuormakoot kasvavat. Kuljetukset voidaan hoitaa pienemmällä kalustomäärällä, jolloin myös kuljetuskustannukset laskevat.

Fiber-reinforced Composite as Oral Implant Material. Experimental studies of glass fiber and bioactive glass in vitro and in vivo

Fiber-reinforced composite as oral implant material: Experimental studies of glass fiber and bioactive glass in vitro and in vivo Department of Prosthetic Dentistry and Biomaterials Science, Institute of Dentistry, University of Turku, Turku, Finland 2008. Biocompatibility and mechanical properties are important variables that need to be determined when new materials are considered for medical implants. Special emphasis was placed on these characteristics in the present work, which aimed to investigate the potential of fiber-reinforced composite (FRC) material as an oral implant. Furthermore, the purpose of this study was to explore the effect of bioactive glass (BAG) on osseointegration of FRC implants. The biocompatibility and mechanical properties of FRC implants were studied both in vitro and in vivo. The mechanical properties of the bulk FRC implant were tested with a cantilever bending test, torsional test and push-out test. The biocompatibility was first evaluated with osteoblast cells cultured on FRC substrates. Bone bonding was determined with the mechanical push-out test and histological as well as histomorplanimetric evaluation. Implant surface was characterized with SEM and EDS analysis. The results of these studies showed that FRC implants can withstand the static load values comparably to titanium. Threaded FRC implants had significantly higher push-out strength than the threaded titanium implants. Cell culture study revealed no cytotoxic effect of FRC materials on the osteoblast-like-cells. Addition of BAG particles enhanced cell proliferation and mineralization of the FRC substrates The in vivo study showed that FRC implants can withstand static loading until failure without fracture. The results also suggest that the FRC implant is biocompatible in bone. The biological behavior of FRC was comparable to that of titanium after 4 and 12 weeks of implantation. Furthermore, addition of BAG to FRC implant increases peri-implant osteogenesis and bone maturation.

Non-resorbable glass fibre-reinforced composite with porous surface as bone substitute material: Experimental studies in vitro and in vivo focused on bone-implant interface

The development of load-bearing osseous implant with desired mechanical and surface properties in order to promote incorporation with bone and to eliminate risk of bone resorption and implant failure is a very challenging task. Bone formation and resoption processes depend on the mechanical environment. Certain stress/strain conditions are required to promote new bone growth and to prevent bone mass loss. Conventional metallic implants with high stiffness carry most of the load and the surrounding bone becomes virtually unloaded and inactive. Fibre-reinforced composites offer an interesting alternative to metallic implants, because their mechanical properties can be tailored to be equal to those of bone, by the careful selection of matrix polymer, type of fibres, fibre volume fraction, orientation and length. Successful load transfer at bone-implant interface requires proper fixation between the bone and implant. One promising method to promote fixation is to prepare implants with porous surface. Bone ingrowth into porous surface structure stabilises the system and improves clinical success of the implant. The experimental part of this work was focused on polymethyl methacrylate (PMMA) -based composites with dense load-bearing core and porous surface. Three-dimensionally randomly orientated chopped glass fibres were used to reinforce the composite. A method to fabricate those composites was developed by a solvent treatment technique and some characterisations concerning the functionality of the surface structure were made in vitro and in vivo. Scanning electron microscope observations revealed that the pore size and interconnective porous architecture of the surface layer of the fibre-reinforced composite (FRC) could be optimal for bone ingrowth. Microhardness measurements showed that the solvent treatment did not have an effect on the mechanical properties of the load-bearing core. A push-out test, using dental stone as a bone model material, revealed that short glass fibre-reinforced porous surface layer is strong enough to carry load. Unreacted monomers can cause the chemical necrosis of the tissue, but the levels of leachable resisidual monomers were considerably lower than those found in chemically cured fibre-reinforced dentures and in modified acrylic bone cements. Animal experiments proved that surface porous FRC implant can enhance fixation between bone and FRC. New bone ingrowth into the pores was detected and strong interlocking between bone and the implant was achieved.

Economics of combined power plant and pyrolysis bio-oil production

There are reasons of necessity in bio-fuel use and bio-energy fast development. It includes the material about bio-energy technologies, applications and methods. There are basic thermodynamics and economic theories. The economic calculation presents the comparison between two combinations. There are boiler plant below 20 MW in combination with ablative pyrolysis plant for bio-oil production and CHP plant below 100 MW in combination with the RTP pyrolysis bio-oil production technology. It provides a material about wood chips and bio-oil characteristics and explains it nature, presents the situation around the bio-fuel market or bio-fuel trade. There is a description of pyrolysis technologies such as ablative and RTP. The liquid product of the pyrolysis processes is bio-oil. The bio-oil could be different even of the same production process, because of the raw material nature and characteristics. The calculation shows advantages and weaknesses of combinations and obtained a proof of suppositions. The next thing, proven by this work is the fact that to get more efficiency from energy project it is good possibility to built plants in combinations.

Bioactive Glass in Lumbar Spondylodesis. A Pre-Clinical and Clinical Study

Bioactive glasses (BGs) form a group of synthetic, surface-active, composition-dependent, silica-based biomaterials with osteoconductive, osteopromotive, and even angiogenic, as well as antibacterial, properties. A national interdisciplinary research group, within the Combio Technology Program (2003–2007), developed a porous load-bearing composite for surgical applications made of BG 1–98 and polymer fibers. The pre-clinical part of this thesis focused on the in vitro and in vivo testing of the composite materials in a rabbit femur and spinal posterolateral fusion model. The femur model failed to demonstrate the previously seen positive effect of BG 1–98 on osteogenesis, probably due to the changed resorption properties of BG in the form of fibers. The spine study was terminated early due to adverse events. In vitro cultures showed the growth inhibition of human mesenchymal stems next to BG 1–98 fibers and radical pH changes. A prospective, long-term, follow-up study was conducted on BG–S53P4 and autogenous bone used as bone graft substitutes for instrumented posterolateral spondylodesis in the treatment of degenerative spondylolisthesis (n=17) and unstable burst fractures (n=10) during 1996–1998. The operative outcome was evaluated from X-rays and CT scans, and a clinical examination was also performed. On the BG side, a solid fusion was observed in the CT scans of 12 patients, and a partial fusion was found in 5 patients, the result being a total fusion rate in all fusion sites (n=41) 88% for levels L4/5 and L5/S1 in the spondylolisthesis group. In the spine fracture group, solid fusion was observed in five patients, and partial fusion was found in five resulting in a total fusion rate of 71% of all fusion sites (n=21). The pre-clinical results suggest that under certain conditions the physical form of BG can be more critical than its chemical composition when a clinical application is designed. The first long-term clinical results concerning the use of BG S53P4 as bone graft material in instrumented posterolateral spondylodesis seems to be a safe procedure, associated with a very low complication rate. BG S53P4 used as a stand-alone bone substitute cannot be regarded as being as efficient as AB in promoting solid fusion.

Gelatin as an additive in bio-based barrier films

The main objective of the present study was to verify the approach on starch-gelatin blending for the paperboard coating formulations with enhanced barrier and mechanical properties. Based on that, another objective was to find out, how the approach will function with wood-based polysaccharides (CMC, EHEC and HPC) by analyzing their barrier properties and convertibility. The last objective was to find out, if pigments can be used in the composition of polysaccharide-protein blends without causing any negative effect on stated properties. The whole process chain of the barrier coating development was studied in the research. The methodology applied included pilot-scale coating and converting trials for the evaluation of mechanical properties of obtained coatings, namely their exposure to cracking with the loss of barrier properties. The results obtained indicated that the combination of starch with gelatin, in fact, improves the grease barrier properties and flexibility of starch-based coatings, thereby confirming the offered approach. The similar results were obtained for CMC, exhibited elevated barrier properties and surface coverage, proving that the approach also functions with wood-based polysaccharides. The introduction of equal amounts of talc gave various effects at different gelatin dosages on barrier properties of wood-based polysaccharides. Mainly, the elevation of grease barrier properties was observed. The convertibility of talc-filled coatings was not sufficient.

Development of porous glass-fiber reinforced composite for bone implants. Evaluation of antimicrobial effect and implant fixation

Cranial bone reconstructions are necessary for correcting large skull bone defects due to trauma, tumors, infections and craniotomies. Traditional synthetic implant materials include solid or mesh titanium, various plastics and ceramics. Recently, biostable glass-fiber reinforced composites (FRC), which are based on bifunctional methacrylate resin, were introduced as novel implant solution. FRCs were originally developed and clinically used in dental applications. As a result of further in vitro and in vivo testing, these composites were also approved for clinical use in cranial surgery. To date, reconstructions of large bone defects were performed in 35 patients. This thesis is dedicated to the development of a novel FRC-based implant for cranial reconstructions. The proposed multi-component implant consists of three main parts: (i) porous FRC structure; (ii) bioactive glass granules embedded between FRC layers and (iii) a silver-polysaccharide nanocomposite coating. The porosity of the FRC structure should allow bone ingrowth. Bioactive glass as an osteopromotive material is expected to stimulate the formation of new bone. The polysaccharide coating is expected to prevent bacterial colonization of the implant. The FRC implants developed in this study are based on the porous network of randomly-oriented E-glass fibers bound together by non-resorbable photopolymerizable methacrylate resin. These structures had a total porosity of 10–70 volume %, of which > 70% were open pores. The pore sizes > 100 μm were in the biologically-relevant range (50-400 μm), which is essential for vascularization and bone ingrowth. Bone ingrowth into these structures was simulated by imbedding of porous FRC specimens in gypsum. Results of push-out tests indicated the increase in the shear strength and fracture toughness of the interface with the increase in the total porosity of FRC specimens. The osteopromotive effect of bioactive glass is based on its dissolution in the physiological environment. Here, calcium and phosphate ions, released from the glass, precipitated on the glass surface and its proximity (the FRC) and formed bone-like apatite. The biomineralization of the FRC structure, due to the bioactive glass reactions, was studied in Simulated Body Fluid (SBF) in static and dynamic conditions. An antimicrobial, non-cytotoxic polysaccharide coating, containing silver nanoparticles, was obtained through strong electrostatic interactions with the surface of FRC. In in vitro conditions the lactose-modified chitosan (chitlac) coating showed no signs of degradation within seven days of exposure to lysozyme or one day to hydrogen peroxide (H2O2). The antimicrobial efficacy of the coating was tested against Staphylococcus aureus and Pseudomonas aeruginosa. The contact-active coating had an excellent short time antimicrobial effect. The coating neither affected the initial adhesion of microorganisms to the implant surface nor the biofilm formation after 24 h and 72 h of incubation. Silver ions released to the aqueous environment led to a reduction of bacterial growth in the culture medium.

Unidirectional fiber-reinforced composite as an oral implant abutment material: Experimental studies of E-glass fiber/BisGMA-TEGDMA polymer in vitro

Fiber-reinforced composites (FRCs) are a new group of non-metallic biomaterials showing a growing popularity in many dental and medical applications. As an oral implant material, FRC is biocompatible in bone tissue environment. Soft tissue integration to FRC polymer material is unclear. This series of in vitro studies aimed at evaluating unidirectional E-glass FRC polymer in terms of mechanical, chemical, and biological properties in an attempt to develop a new non-metallic oral implant abutment alternative. Two different types of substrates were investigated: (a) Plain polymer (BisGMA 50%–TEGDMA 50%) and (b) Unidirectional FRC. The mechanical behavior of high fiber-density FRCs was assessed using a three-point bending test. Surface characterization was performed using scanning electron and spinning disk confocal microscopes. The surface wettability/energy was determined using sessile drop method. The blood response, including blood-clotting ability and platelet morphology was evaluated. Human gingival fibroblast cell responses - adhesion kinetics, adhesion strength, and proliferation activity - were studied in cell culture environment using routine test conditions. A novel tissue culture method was developed and used to evaluate porcine gingival tissue graft attachment and growth on the experimental composite implants. The analysis of the mechanical properties showed that there is a direct proportionality in the relationship between E-glass fiber volume fraction and toughness, modulus of elasticity, and load bearing capacity; however, flexural strength did not show significant improvement when high fiber-density FRC is used. FRCs showed moderate hydrophilic properties owing to the presence of exposed glass fibers on the polymer surface. Blood-clotting time was shorter on FRC substrates than on plain polymer. The FRC substrates also showed higher platelet activation state than plain polymer substrates. Fibroblast cell adhesion strength and proliferation rate were highly pronounced on FRCs. A tissue culture study revealed that gingival epithelium and connective tissue established an immediate close contact with both plain polymer and FRC implants. However, FRC seemed to guide epithelial migration outwards from the tissue/implant interface. Due to the anisotropic and hydrophilic nature of FRC, it can be concluded that this material enhances biological events related with soft tissue integration on oral implant surface.

Työvoiman ja koulutuksen tarvetutkimus 2009 : Yhteenveto bio- ja lääkealan työnantajahaastatteluista Asiantuntijaraadin SWOT-analyysi 2.3.2010

Varsinais-Suomen ELY-keskus teettää säännöllisesti maakunnan valikoiduille toimialoille työvoiman ja koulutuksen tarvetutkimuksia (TKTT). Tähän raporttiin on koottu bio- ja terveysalan TKTT-prosessin kaikki osiot: toimialan tilastotiedot, yrityshaastattelut syksyltä 2009, 2.3.2010 järjestetyn asiantuntijaraadin yhteenveto ja Delfoi-kierroksen tulokset. Varsinais-Suomi on kotimaassa lääketieteellisen bioalan kärkeä ja kansainvälistä huippua tietyillä tutkimusalueilla. Tässä työssä toimiala luokitellaan määritelmällä ”bioja terveysala”, johon kuuluvat lääkkeiden kehitys- ja valmistus, diagnostiikka, bioalan palvelut ja biomateriaalit. Toimialalla oli yrityksiä vuonna 2008 tehdyn kartoituksen perusteella noin 100, liikevaihdon ollessa yhteensä noin 522 miljoonaa €. Ala työllisti suoraan yli 2500 henkilöä, jonka lisäksi on huomioitava merkittävä alihankintaverkosto. Bio- ja terveysalan yrityskenttä jakautuu useisiin pienyrityksiin ja muutamiin suuryrityksiin, jotka työllistävät pääosan alan henkilöstöstä. Bioalan kehitystä koordinoi Turku Science Parkin BioTurku, joka on luonut vuonna 2009 uusimman strategian kasvuodotusten toteuttamiseksi. Viime vuosina Varsinais-Suomeen on syntynyt erityisesti biopalvelu- ja liiketoiminnankehitysyrityksiä. Alan koulutusta tarjotaan runsaasti, pääasiassa yliopistoissa ja ammattikorkeakoulussa. Aloituspaikkoja vuonna 2009 oli Turussa yhteensä 174. TKTT-haastattelut tehtiin yrityksissä loka-marraskuussa 2009: niissä haastateltiin 24 toimijaa, jotka työllistivät kaikkiaan 1849 henkilöä. Muutaman suuren yrityksen ansiosta määrä vastaa noin 70 % alan koko työvoimasta, mutta kattaa myös kaikki toimialamäärittelyssä esitetyt alaluokat Varsinais-Suomessa. Tutkimuskohteista pkyrityksiin lukeutui 80 %, mutta kokonaishenkilöstöstä 86 % työskenteli kolmen suurimman yrityksen palveluksessa. Yritysten näkymät vuonna 2009 olivat tilastollisesti optimistisia taloustilanteeseen nähden, ja lama on selvästikin taittumassa alalla. Vuoden kuluessa työllistävyyskehitys on kuitenkin vielä varovaista. Henkilöstön nettomäärä haastatelluissa yrityksissä lisääntyy syksyyn 2010 mennessä noin 11 henkilöllä. Suurin kasvu (20 %) on alle 10 henkeä työllistävissä mikroyrityksissä, ja työvoiman vähenemä koostuu pääasiassa suurempien yritysten eläkkeelle siirtyvistä työntekijöistä. Bio- ja terveysalalla on moninaisia tutkimukseen ja tuotantoon liittyviä toimenkuvia. Yleisimpiä ammattinimikkeitä haastatelluissa yrityksissä olivat kemisti, laborantti, insinööri ja tuotantotyöntekijä. Diagnostiikka-alan alihankintatöissä tarvitaan elektroniikka-asentajia. Henkilöstön ikärakenne painottuu 25-39-vuotiaisiin, joita on yli 40 % työvoimasta. Nuoria alle 24-vuotiaita työntekijöitä on erittäin vähän, mutta toisaalta vain 2 % työntekijöistä on eläköitymässä kahden vuoden kuluessa. Haastattelutulosten mukaan syksyllä 2009 noin puolessa yrityksistä elettiin nousukauden alkua, ja lamaan itsensä sijoitti viidennes. Syksyllä 2010 yrityksistä jo 95 % uskoo olevansa suhdannekäyrän positiivisella puolella, mutta kasvupotentiaalia on vielä huomattavasti. Haastatteluhetkellä työvoiman käyttöaste oli pääosin sopiva ja vain neljällä yrityksellä alhainen.

Bio-ethanol valorization towards C4s including 1-butanol over metal modified alumina and zeolite catalysts

Bio-ethanol has been used as a fuel additive in modern society aimed at reducing CO2-emissions and dependence on oil. However, ethanol is unsuitable as fuel supplement in higher proportions due to its physico-chemical properties. One option to counteract the negative effects is to upgrade ethanol in a continuous fixed bed reactor to more valuable C4 products such as 1-butanol providing chemical similarity with traditional gasoline components. Bio-ethanol based valorization products also have other end-uses than just fuel additives. E.g. 1-butanol and ethyl acetate are well characterised industrial solvents and platform chemicals providing greener alternatives. The modern approach is to apply heterogeneous catalysts in the investigated reactions. The research was concentrated on aluminium oxide (Al2O3) and zeolites that were used as catalysts and catalyst supports. The metals supported (Cu, Ni, Co) gave very different product profiles and, thus, a profound view of different catalyst preparation methods and characterisation techniques was necessary. Additionally, acidity and basicity of the catalyst surface have an important role in determining the product profile. It was observed that ordinary determination of acid strength was not enough to explain all the phenomena e.g. the reaction mechanism. One of the main findings of the thesis is based on the catalytically active site which originates from crystallite structure. As a consequence, the overall evaluation of different by-products and intermediates was carried out by combining the information. Further kinetic analysis was carried out on metal (Cu, Ni, Co) supported self-prepared alumina catalysts. The thesis gives information for further catalyst developments aimed to scale-up towards industrially feasible operations.