{"id":17898,"date":"2021-09-29T20:25:44","date_gmt":"2021-09-29T17:25:44","guid":{"rendered":"http:\/\/cit.itim-cj.ro\/?page_id=17898"},"modified":"2021-10-01T07:59:35","modified_gmt":"2021-10-01T04:59:35","slug":"poveste-de-succes-raport-final-contract-subsidiar-teracrystal","status":"publish","type":"page","link":"http:\/\/cit.itim-cj.ro\/en\/poveste-de-succes-raport-final-contract-subsidiar-teracrystal\/","title":{"rendered":"Poveste de succes &#8211; Raport final contract subsidiar TeraCrystal"},"content":{"rendered":"<div      class=\"vc_row wpb_row section vc_row-fluid\" style=' text-align:left;'><div class=\"full_section_inner clearfix\"><div class=\"wpb_column vc_column_container vc_col-sm-3\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div  class=\"wpb_widgetised_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t\n\t\t\t<div class=\"widget widget_nav_menu\"><h5>Poveste de succes<\/h5><div class=\"menu-lista_succes-container\"><ul id=\"menu-lista_succes\" class=\"menu\"><li id=\"menu-item-17921\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-17921\"><a href=\"http:\/\/cit.itim-cj.ro\/en\/poveste-de-succes-raport-final-contract-subsidiar-teracrystal\/\">Contract subsidiar TeraCrystal<\/a><\/li>\n<li id=\"menu-item-17687\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-17687\"><a href=\"http:\/\/cit.itim-cj.ro\/en\/poveste-de-succes-raport-final-contract-subsidiar-etera-prod\/\">Contract subsidiar Etera Prod<\/a><\/li>\n<li id=\"menu-item-17686\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-17686\"><a href=\"http:\/\/cit.itim-cj.ro\/en\/poveste-de-succes-raport-final-contract-subsidiar-parapharm\/\">Contract subsidiar Parapharm<\/a><\/li>\n<li id=\"menu-item-17819\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-17819\"><a href=\"http:\/\/cit.itim-cj.ro\/en\/poveste-de-succes-raport-final-contract-subsidiar-icpe-bistrita\/\">Contract subsidiar ICPE Bistri\u021ba<\/a><\/li>\n<li id=\"menu-item-17853\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-17853\"><a href=\"http:\/\/cit.itim-cj.ro\/en\/poveste-de-succes-raport-final-contract-subsidiar-agro-cosm-fan\/\">Contract subsidiar Agro Cosm Fan 1<\/a><\/li>\n<li id=\"menu-item-17880\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-17880\"><a href=\"http:\/\/cit.itim-cj.ro\/en\/poveste-de-succes-raport-final-contract-subsidiar-agro-cosm-fan-2\/\">Contract subsidiar Agro Cosm Fan 2<\/a><\/li>\n<\/ul><\/div><\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-9\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<h3>Servicii \u00een sectorul farmaceutic<\/h3>\n\n\t\t<\/div> \n\t<\/div> <div class=\"separator  transparent\" style=\"\"><\/div>\n\n\t<div class=\"wpb_single_image wpb_content_element vc_align_center  vc_custom_1632936274151\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t\n\t\t\t<div class=\"vc_single_image-wrapper vc_box_shadow  vc_box_border_grey\"><img width=\"1000\" height=\"523\" src=\"http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/poveste-de-succes-TeraCrystal.jpg\" class=\"vc_single_image-img attachment-full\" alt=\"\" loading=\"lazy\" srcset=\"http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/poveste-de-succes-TeraCrystal.jpg 1000w, http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/poveste-de-succes-TeraCrystal-300x157.jpg 300w, http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/poveste-de-succes-TeraCrystal-768x402.jpg 768w, http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/poveste-de-succes-TeraCrystal-18x9.jpg 18w, http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/poveste-de-succes-TeraCrystal-700x366.jpg 700w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div><\/div><div      class=\"vc_row wpb_row section vc_row-fluid\" style=' text-align:left;'><div class=\"full_section_inner clearfix\"><div class=\"wpb_column vc_column_container vc_col-sm-3\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-9\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<div align=\"justify\">Sub o presiune constant\u0103 de reducere a costurilor \u0219i de cre\u0219tere a eficien\u021bei, industria farmaceutic\u0103 \u0219i-a remodelat structurile tradi\u021bionale de Cercetare&amp;Dezvoltare (R&amp;D) \u0219i au crescut substan\u021bial externalizarea anumitor servicii (<em>outsourcingul<\/em>). Se estimeaz\u0103 c\u0103, \u00een prezent, procentul de outsourcing atinge aproape 67%, cu o valoare de pia\u021b\u0103 de peste 200 de miliarde de dolari.<br \/>\nTeraCrystal este o companie de Cercetare pe baz\u0103 de Contract (<em>CRO \u2013 Contract Research Organization<\/em>) care furnizeaz\u0103 servicii specializate de cristalizare, studiu al st\u0103rii solide \u0219i inginerie cristalin\u0103, axate pe dou\u0103 direc\u021bii:<\/div>\n<ol>\n<li>Servicii comerciale de cercetare-dezvoltare \u00een domeniul Cristaliz\u0103rii \u0219i Studiului St\u0103rii Solide pentru compu\u0219i biologic activi, care sus\u021bin opera\u021biile curente \u0219i finan\u021beaz\u0103 programele de cercetare interne.<\/li>\n<li>Cercetare proprie, care genereaz\u0103 extinderea portofoliului de servicii comerciale \u0219i de proprietate intelectual\u0103, conduc\u00e2nd la cre\u0219terea cifrei de afaceri \u0219i a valorii de pia\u021b\u0103 a companiei.<\/li>\n<\/ol>\n\n\t\t<\/div> \n\t<\/div> <\/div><\/div><\/div><\/div><\/div><div      class=\"vc_row wpb_row section vc_row-fluid  vc_custom_1632936895655\" style=' text-align:left;'><div class=\"full_section_inner clearfix\"><div class=\"wpb_column vc_column_container vc_col-sm-3\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-9\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<div align=\"justify\">\n<h4>STABILITATEA<\/h4>\n<\/div>\n<div align=\"justify\">\n<p>Stabilitatea medicamentelor afecteaz\u0103 siguran\u0163a, eficacitatea \u015fi calitatea unui medicament. Impurit\u0103\u0163ile ap\u0103rute \u00een urma degrad\u0103rii pot provoca pierderea eficacit\u0103\u0163ii \u015fi pot genera efecte adverse nedorite.<img loading=\"lazy\" class=\"alignright wp-image-17928 size-full\" src=\"http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/ritonavirus-1.png\" alt=\"\" width=\"410\" height=\"409\" srcset=\"http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/ritonavirus-1.png 410w, http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/ritonavirus-1-300x300.png 300w, http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/ritonavirus-1-150x150.png 150w, http:\/\/cit.itim-cj.ro\/wp-content\/uploads\/2021\/09\/ritonavirus-1-12x12.png 12w\" sizes=\"(max-width: 410px) 100vw, 410px\" \/> Structural, stabilitatea este str\u00e2ns legat\u0103 de posibilitatea existen\u021bei, pentru o aceea\u0219i molecul\u0103 activ\u0103, mai multor modalit\u0103\u021bi diferite de \u00eempachetare cristalin\u0103 \u2013 a\u0219a numi\u021bii polimorfi.<\/p>\n<p><strong>Exemplu:<\/strong> Ritonavirul, un medicament folosit \u00een tramentul SIDA, a fost descoperit \u00een 1992 sub o singur\u0103 form\u0103 cristalin\u0103, Forma I, iar \u00een 1996 a fost introdus pe pia\u0163\u0103 Norvir sub forma unor capsule. \u00cen 1998, \u00een urma faptului c\u0103 unele capsule nu au mai trecut testul solubilit\u0103\u0163ii, a fost descoperit un alt polimorf stabil al acestuia, Forma II, av\u00e2nd o energie liber\u0103 mai mic\u0103 \u015fi o solubilitate mult redus\u0103. Deoarece chiar \u015fi o urm\u0103 de Forma II determin\u0103 conversia Formei I, mai solubile, \u00een Forma II, \u015fi impurificarea cu Forma II se produsese la toate fabricile companiei, aceasta a fost nevoit\u0103 s\u0103 retrag\u0103 capsulele de pe pia\u0163\u0103. Compania a pierdut sute de milioane de dolari \u00een \u00eencercarea de a izola \u015fi produce Forma I.<\/p>\n<\/div>\n\n\t\t<\/div> \n\t<\/div> <\/div><\/div><\/div><\/div><\/div><div      class=\"vc_row wpb_row section vc_row-fluid\" style=' text-align:left;'><div class=\"full_section_inner clearfix\"><div class=\"wpb_column vc_column_container vc_col-sm-3\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-9\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element  vc_custom_1632936550462\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p align=\"justify\">\u00cen cazul dezvolt\u0103rii medicamentelor cu administrare oral\u0103, importan\u021ba stabilit\u0103\u021bii \u0219i solubilit\u0103\u021bii compu\u0219ilor farmaceutic activi se reflect\u0103 \u00een resursele financiare alocate pentru ob\u021binerea unor forme solide c\u00e2t mai stabile \u0219i cu solubilitate c\u00e2t mai ridicat\u0103. Ingestia oral\u0103 este modul cel mai convenabil de administrare a medicamentelor, datorit\u0103 usurin\u021bei de administrare \u0219i de respectare a schemei de tratament de c\u0103tre pacient, a flexibilit\u0103\u021bii doz\u0103rii compusului activ \u00een formularea medicamentului, precum \u0219i a costurilor mai mici comparativ cu alte moduri de administrare.<\/p>\n<p align=\"justify\">La dezvoltarea unui compus farmaceutic nou este deosebit de important\u0103 c\u0103utarea tuturor formelor polimorfe \u0219i identificarea \u2013 \u00eenc\u0103 din faza incipien\u021b\u0103 \u2013 a formelor cristaline celor mai stabile \u0219i evaluarea sistematic\u0103 a riscului de dezvoltare a formelor mai putin stabile, \u00eens\u0103 cu solubilitate mai ridicat\u0103.<\/p>\n<p align=\"justify\">Parteneriatul TeraCrystal \u2013 INCDTIM a reprezentat o oportunitate excelent\u0103 pentru cei doi parteneri de dezvoltare a unor metodologii avansate de abordare a st\u0103rii solide a compu\u0219ilor biologic activi, cu poten\u021bial important de comercializare sub form\u0103 de servicii pentru industria farmaceutic\u0103. Astfel, \u00een cadrul contractului \u201c<em>Servicii <\/em><em>inovative \u00een optimizarea formelor solide ale compu\u0219ilor biologic activi<\/em>\u201d, cei doi parteneri au urm\u0103rit elaborarea:<\/p>\n<ul>\n<li>unei <em>metodologii optime de studiu conforma\u021bional<\/em> care s\u0103 direc\u021bioneze proiectarea experimentelor de polimorfism specifice industriei farmaceutice \u0219i<\/li>\n<li>a unei <em>metodologii de diferen\u021biere a formelor farmaceutice de tip sare sau cocristal<\/em> prin utilizarea RMN-ss combinat\u0103 cu mod<\/li>\n<\/ul>\n\n\t\t<\/div> \n\t<\/div> <\/div><\/div><\/div><\/div><\/div><div      class=\"vc_row wpb_row section vc_row-fluid  vc_custom_1632936877030\" style=' text-align:left;'><div class=\"full_section_inner clearfix\"><div class=\"wpb_column vc_column_container vc_col-sm-3\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-9\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<div align=\"justify\">\n<h4>S\u0102RURI \u0218I COCRISTALE<\/h4>\n<p>\u00cen industria farmaceutic\u0103, deoarece moleculele active sunt tot mai mari \u0219i mai pu\u021bin solubile \u2013 \u020bn consecin\u021b\u0103, mai pu\u021bin biodisponibile pentru\u00a0 organism \u2013 se caut\u0103 combina\u021bii ale acestora cu alte molecule (coformer), acceptate din punct\u00a0 de vedere farmacologic, astfel \u00eenc\u0203t s\u0103 se ob\u1e6din\u0103 forme solide cu solubilitate \u0219i biodisponibilitate \u020bmbun\u0103t\u0103\u021bite. Aceste combina\u021bii implic\u0103 numero\u0219i compu\u0219i \u0219i experimente de cristalizare pentru a g\u0103si forma solid\u0103 optim\u0103.<\/p>\n<p>Interac\u021biunile dintre cele dou\u0103 tipuri de molecule implicate \u020bn formarea noii forme solide pot fi de diverse tipuri: leg\u0103turi de hidrogen, interac\u021biuni C\u2013H\u00b7\u00b7\u00b7\u03c0, \u03c0\u2013\u03c0 stacking, van der Waals.<\/p>\n<p>Dac\u0103 exist\u0103 un transfer de proton de la un acid la o baz\u0103 se formeaz\u0103 sare (apare o ionizare a moleculelor), iar dac\u0103 nu are loc transferul de proton \u0219i\u00a0 moleculele r\u0103m\u0203n \u020bn stare neutr\u0103 se formeaz\u0103 un cocristal.<\/p>\n<p>Aceste forme combinate au un comportament diferit \u020bn organism, iar c\u0203nd un dezvoltator de produse farmaceutice dore\u0219te s\u0103 introduc\u0103 pe pia\u1e6d\u0103 un astfel de produs trebuie s\u0103 specifice caracterul de sare sau cocristal al acestuia, iar metodele analitice utilizate sunt complexe.<\/p>\n<\/div>\n\n\t\t<\/div> \n\t<\/div> <\/div><\/div><\/div><\/div><\/div><div      class=\"vc_row wpb_row section vc_row-fluid  vc_custom_1632936877030\" style=' text-align:left;'><div class=\"full_section_inner clearfix\"><div class=\"wpb_column vc_column_container vc_col-sm-3\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-9\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<div align=\"justify\">Spectroscopia RMN pe solide este o tehnic\u0103 foarte sensibil\u0103 \u0219i cu rezolu\u021bie ridicat\u0103, capabil\u0103 s\u0103 identifice modific\u0103rile structurale locale. Exist\u0103 cazuri particulare \u00een care nici difrac\u021bia de raze X pe monocristal nu poate confirma natura formei solide (sare sau cocristal), tehnica RMN pe solide oferind \u00een acest caz informa\u021biile suplimentare necesare.<\/div>\n<p align=\"justify\">\u00cen cadrul proiectului de cercetare dezvoltat \u00een parteneriat cu SC TeraCrystal SRL, INCDTIM a dezvoltat o metodologie bazat\u0103 at\u00e2t pe tehnica RMN pe solide, c\u00e2t \u0219i pe modelarea molecular\u0103, metodologie care, \u00een func\u021bie de particularit\u0103\u021bile cazului abordat \u2013 dac\u0103 se cunoa\u0219te sau nu structura cristalin\u0103 a formei solide cercetate \u2013, are capacitatea de a furniza informa\u021bii privind caracterul de sare sau cocristal al compusului de interes pentru beneficiar. \u00cen acest scop, se face o analiz\u0103 a spectrelor 15N CP-MAS RMN \u2013 at\u00e2t ale noii forme solide, c\u00e2t \u0219i ale compusului activ de pornire \u2013 urm\u0103rindu-se identificarea pozi\u021biilor atomilor de azot care este posibil s\u0103-\u0219i fi schimbat starea de ionizare prin acceptarea unui proton. Dac\u0103 beneficiarul cunoa\u0219te\u00a0 structura cristalin\u0103 a compusului de interes, se poate investiga caracterul de sare sau cocristal \u0219i prin modelare molecular\u0103, prin optimizare de geometrie \u0219i calcul de deplasare chimic\u0103 RMN.<\/p>\n<div align=\"justify\">Dezvoltarea acestor metodologii \u00een parteneriat INCDTIM \u2013 SC TeraCrystal SRL s-a bazat pe solicitarile concrete venite din partea clien\u021bilor TeraCrystal. Astfel, acestea vor face parte din strategia TeraCrystal de extindere \u0219i continu\u0103 \u00eembun\u0103t\u0103\u021bire a serviciilor proprii, specializate, de cercetare pentru industria farmaceutic\u0103. \u00cen plus, proiectul a dus la consolidarea parteneriatul INCDTIM cu mediul economic.<\/div>\n\n\t\t<\/div> \n\t<\/div> <\/div><\/div><\/div><\/div><\/div><div      class=\"vc_row wpb_row section vc_row-fluid\" style=' text-align:left;'><div class=\"full_section_inner clearfix\"><div class=\"wpb_column vc_column_container vc_col-sm-3\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-9\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element  vc_custom_1633064370841\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<div align=\"justify\"><em><strong>Contractul subsidiar Nr. 264\/27.03.2019 \u00eencheiat \u00eentre INCDTIM Cluj-Napoca \u0219i SC TeraCrystal SRL a fost derulat pe parcursul a 30 de luni. Valoarea total\u0103 a contractului a fost de 1.219.250 de lei, din care 120.000 de lei reprezint\u0103 contribu\u021bia privat\u0103 a companiei, iar 1.080.000 de lei reprezint\u0103 valoarea total\u0103 eligibil\u0103 nerambursabil\u0103 acordat\u0103 prin intermediul proiectului \u201cCre\u0219terea capacit\u0103\u021bii de transfer tehnologic \u0219i de cuno\u0219tin\u021be a INCDTIM Cluj \u00een domeniul bioeconomiei TTC-ITIM\u201d (Cod SMIS 105533), derulat \u00een cadrul Programului Opera\u021b\u001cional Competitivitate 2014-2020.<\/strong><\/em><\/div>\n<p><a href=\"\/wp-content\/uploads\/2021\/10\/Poveste-de-succes-Teracrystal.pdf\" target=\"_blank\" rel=\"noopener\">Descarc\u0103 Povestea de succes TeraCrystal \u00een format pdf.<\/a><\/p>\n\n\t\t<\/div> \n\t<\/div> <\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"Poveste de succesContract subsidiar TeraCrystal Contract subsidiar Etera Prod Contract subsidiar Parapharm Contract subsidiar ICPE Bistri\u021ba Contract subsidiar Agro Cosm Fan 1 Contract subsidiar Agro Cosm Fan 2 Servicii \u00een sectorul farmaceutic Sub o presiune constant\u0103 de reducere a costurilor \u0219i de cre\u0219tere a eficien\u021bei,...","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"http:\/\/cit.itim-cj.ro\/en\/wp-json\/wp\/v2\/pages\/17898"}],"collection":[{"href":"http:\/\/cit.itim-cj.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/cit.itim-cj.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/cit.itim-cj.ro\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"http:\/\/cit.itim-cj.ro\/en\/wp-json\/wp\/v2\/comments?post=17898"}],"version-history":[{"count":29,"href":"http:\/\/cit.itim-cj.ro\/en\/wp-json\/wp\/v2\/pages\/17898\/revisions"}],"predecessor-version":[{"id":17947,"href":"http:\/\/cit.itim-cj.ro\/en\/wp-json\/wp\/v2\/pages\/17898\/revisions\/17947"}],"wp:attachment":[{"href":"http:\/\/cit.itim-cj.ro\/en\/wp-json\/wp\/v2\/media?parent=17898"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}