{"id":24446,"date":"2025-10-30T08:58:36","date_gmt":"2025-10-30T07:58:36","guid":{"rendered":"https:\/\/kymos.com\/?p=24446"},"modified":"2025-10-30T09:15:58","modified_gmt":"2025-10-30T08:15:58","slug":"oligoxplorer","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/oligoxplorer\/","title":{"rendered":"OligoXplorer: La nostra plataforma CMC per a oligonucle\u00f2tids terap\u00e8utics"},"content":{"rendered":"

Les ter\u00e0pies basades en oligonucle\u00f2tids<\/strong> s’han convertit en una de les classes de f\u00e0rmacs m\u00e9s prometedores de la medicina moderna. La seva capacitat per atacar malalties a nivell gen\u00e8tic no t\u00e9 parang\u00f3, per\u00f2 la seva qu\u00edmica planteja un nou conjunt de reptes anal\u00edtics<\/strong> . Cada modificaci\u00f3 en la seq\u00fc\u00e8ncia, la longitud o la cadena principal pot influir en l’activitat, la seguretat i l’estabilitat. Per tant, tant per als desenvolupadors com per als reguladors, els m\u00e8todes fiables per caracteritzar<\/strong> aquestes mol\u00e8cules s\u00f3n essencials per garantir la seva qualitat i consist\u00e8ncia<\/strong> al llarg del cicle de vida del producte.<\/span><\/p>\n

Per abordar aquesta necessitat, Kymos It\u00e0lia ha desenvolupat OligoXplorer<\/strong> , un projecte de recerca i desenvolupament dissenyat per crear una plataforma anal\u00edtica completa per a la caracteritzaci\u00f3 CMC de ter\u00e0pies basades en oligonucle\u00f2tids<\/strong> .<\/span><\/p>\n

El projecte s’ha dut a terme en col\u00b7laboraci\u00f3 amb la Universitat de Camerino (UNICAM)<\/strong> \u2013 Escola de Bioci\u00e8ncies i Medicina Veterin\u00e0ria i ha estat cofinan\u00e7at per la Regione Marche<\/strong> en el marc del seu programa d’innovaci\u00f3 (PR Marche FESR 2021\/2027).<\/span><\/p>\n

M\u00e9s enll\u00e0 del seu abast cient\u00edfic, OligoXplorer marca una fita important per a Kymos Group: consolida la nostra experi\u00e8ncia en TIDES i amplia la nostra cartera amb les proves CMC per a oligonucle\u00f2tids<\/strong> .<\/span><\/p>\n

Comprensi\u00f3 del repte anal\u00edtic<\/strong><\/span><\/h2>\n

Els oligonucle\u00f2tids se situen entre les mol\u00e8cules petites i els productes biol\u00f2gics<\/strong> , massa grans per als m\u00e8todes qu\u00edmics tradicionals, massa petits per a la majoria de bioassajos. La seva gran mida, alta polaritat i tend\u00e8ncia a formar estructures secund\u00e0ries fan que siguin dif\u00edcils de separar, quantificar i seq\u00fcenciar<\/strong> . Com s’ha dit abans, petits canvis en la longitud de la seq\u00fc\u00e8ncia o en la seva composici\u00f3 qu\u00edmica poden afectar la pot\u00e8ncia, l’especificitat i l’estabilitat<\/strong> .<\/span><\/p>\n

Per aquest motiu, les ag\u00e8ncies reguladores esperen paquets CMC complets<\/strong> basats en m\u00e8todes anal\u00edtics ortogonals que confirmin la identitat de la seq\u00fc\u00e8ncia, quantifiquin el contingut i caracteritzin les impureses<\/strong> ; tot aix\u00f2 en condicions validades i reprodu\u00efbles.<\/span><\/p>\n

OligoXplorer es va concebre precisament per abordar aquests reptes: explorar, desenvolupar i validar m\u00e8todes capa\u00e7os de donar suport a totes les etapes de la caracteritzaci\u00f3 d’oligonucle\u00f2tids<\/strong> , des del desenvolupament inicial fins a les proves d’alliberament de GMP.<\/span><\/p>\n

Tres \u00e0rees anal\u00edtiques principals<\/strong><\/span><\/h2>\n

El projecte es va centrar en tres \u00e0rees anal\u00edtiques principals: seq\u00fcenciaci\u00f3, assaig i subst\u00e0ncies relacionades<\/strong> . Cadascun cobreix un atribut cr\u00edtic de qualitat (CQA) en el control d’oligonucle\u00f2tids.<\/span><\/p>\n

Seq\u00fcenciaci\u00f3: Confirmaci\u00f3 de la identitat molecular<\/strong><\/span><\/h2>\n

Determinar que un oligonucle\u00f2tid porta la seq\u00fc\u00e8ncia correcta \u00e9s el primer pas per garantir la seguretat i l’efic\u00e0cia<\/strong> .<\/span>
\nEl nostre equip a It\u00e0lia ha establert i refinat fluxos de treball de LC-MS i HR-MS capa\u00e7os de confirmar la identitat de seq\u00fc\u00e8ncia<\/strong> i revelar variants subtils com ara shortmers, longmers o modificacions qu\u00edmiques.<\/span><\/p>\n

El fraccionament cromatogr\u00e0fic va ajudar a a\u00efllar aquestes variants abans de l’an\u00e0lisi per MS, millorant la resoluci\u00f3 i la fiabilitat. El resultat \u00e9s un conjunt de m\u00e8todes que proporcionen dades d’identitat clares i d’alta qualitat adequades per a l’\u00fas rutinari de proves CMC<\/strong> .<\/span><\/p>\n

Assaig: Mesura del contingut i la for\u00e7a<\/strong><\/span><\/h2>\n

Quantificar oligonucle\u00f2tids<\/strong> \u00e9s igualment dif\u00edcil, i fer-ho amb precisi\u00f3 \u00e9s vital per a la pot\u00e8ncia i la reproductibilitat de la dosi<\/strong> . Les seves propietats fisicoqu\u00edmiques poden afectar la recuperaci\u00f3 i la resposta, especialment durant les proves rutin\u00e0ries.<\/span>
\nPer superar aix\u00f2, Kymos It\u00e0lia ha desenvolupat i validat m\u00e8todes LC-UV i LC-MS<\/strong> per a una quantificaci\u00f3 precisa.<\/span><\/p>\n

La validaci\u00f3 del m\u00e8tode cobreix la linealitat, la precisi\u00f3 i la robustesa, mentre que l’optimitzaci\u00f3 cromatogr\u00e0fica ajuda a separar el pic principal dels senyals de degradaci\u00f3 o impuresa. El resultat \u00e9s un m\u00e8tode d’assaig validat i adequat per al seu \u00fas en programes d’alliberament de lots i estabilitat en entorns GMP<\/strong> .<\/span><\/p>\n

Subst\u00e0ncies relacionades: garantint la puresa i la integritat del producte<\/strong><\/span><\/h2>\n

Fins i tot petites impureses poden afectar el rendiment terap\u00e8utic<\/strong> . Durant la s\u00edntesi, els oligonucle\u00f2tids poden produir una gamma d’esp\u00e8cies truncades o allargades (n\u20131, n+1), o generar impureses qu\u00edmiques mitjan\u00e7ant l’oxidaci\u00f3 o la despurinaci\u00f3. Identificar-les i quantificar-les \u00e9s essencial per a la seguretat del producte i el compliment normatiu<\/strong> .<\/span><\/p>\n

A trav\u00e9s d’ OligoXplorer<\/em> , el nostre equip itali\u00e0 ha establert fluxos de treball de perfilaci\u00f3 d’impureses per LC-UV i LC-MS per detectar i quantificar aquestes esp\u00e8cies<\/strong> amb alta sensibilitat. Estudis comparatius entre lots van confirmar la seva idone\u00eftat per al control de processos i l’avaluaci\u00f3 de l’estabilitat.<\/span><\/p>\n

Junts, aquests desenvolupaments proporcionen una imatge completa de la puresa i la integritat del producte.<\/span><\/p>\n

Capacitats anal\u00edtiques complement\u00e0ries<\/strong><\/span><\/h2>\n

A m\u00e9s de les \u00e0rees anal\u00edtiques principals desenvolupades a trav\u00e9s d’ OligoXplorer<\/em> , Kymos Group pot cobrir altres proves que sovint es requereixen per a materials i formulacions d’oligonucle\u00f2tids<\/strong> . Alguns es duen a terme directament internament, mentre que d’altres es duen a terme a trav\u00e9s de socis de confian\u00e7a amb experi\u00e8ncia demostrada en el camp.<\/span><\/p>\n

Els nostres equips poden determinar el contingut de l\u00edpids en formulacions de LNP mitjan\u00e7ant HPLC-CAD<\/strong> , un par\u00e0metre clau per avaluar l’efici\u00e8ncia de l’encapsulaci\u00f3 i la consist\u00e8ncia de la formulaci\u00f3. Tamb\u00e9 oferim proves de dissolvents residuals, contingut d’acetat de sodi i impureses elementals<\/strong> , garantint el compliment total dels est\u00e0ndards de qualitat actuals de l’ICH i l’EMA.<\/span><\/p>\n

La caracteritzaci\u00f3 f\u00edsica \u00e9s igualment important. Mitjan\u00e7ant la dispersi\u00f3 din\u00e0mica de la llum (DLS), podem mesurar la distribuci\u00f3 de la mida de les part\u00edcules, l’estat d’agregaci\u00f3 i la polidispersi\u00f3<\/strong> , cosa que ajuda a avaluar l’estabilitat i l’homogene\u00eftat del producte.<\/span><\/p>\n

Combinant aquests estudis complementaris amb les nostres an\u00e0lisis de CMC, Kymos Group ofereix una imatge completa de la qualitat dels oligonucle\u00f2tids<\/strong> .<\/span><\/p>\n

De la recerca a la implementaci\u00f3<\/strong><\/span><\/h2>\n

Els m\u00e8todes desenvolupats sota OligoXplorer<\/strong> no s\u00f3n nom\u00e9s prototips; ja estan implementats a Kymos It\u00e0lia i disponibles com a serveis anal\u00edtics validats per a desenvolupadors d’oligonucle\u00f2tids<\/strong> com una plataforma anal\u00edtica coherent per a la CMC d’oligonucle\u00f2tids. Cada m\u00e8tode ha estat desenvolupat, optimitzat i validat utilitzant oligos sint\u00e8tics representatius i ara es pot adaptar a projectes espec\u00edfics de clients.<\/span><\/p>\n

Aix\u00f2 inclou la confirmaci\u00f3 de la identitat, la quantificaci\u00f3 de l’assaig i la creaci\u00f3 de perfils d’impureses, tot realitzat en condicions compatibles amb les GMP i amb el suport dels nostres equips anal\u00edtics experimentats<\/strong> .<\/span><\/p>\n

Amb aix\u00f2, Kymos Group es converteix en una de les poques CRO europees que ofereix suport integrat de CMC i bioanal\u00edtica per a ter\u00e0pies d’oligonucle\u00f2tids<\/strong> , combinant els punts forts de les nostres instal\u00b7lacions a It\u00e0lia i Alemanya.<\/span><\/p>\n

Mirant cap endavant<\/strong><\/span><\/h2>\n

Amb OligoXplorer, Kymos It\u00e0lia ara opera com a centre d’excel\u00b7l\u00e8ncia per a l’an\u00e0lisi de CMC d’oligonucle\u00f2tids dins del Grup<\/strong> . L’experi\u00e8ncia adquirida a trav\u00e9s d’aquest projecte ha perm\u00e8s als nostres equips consolidar els seus coneixements en espectrometria de masses, desenvolupament de m\u00e8todes cromatogr\u00e0fics i perfils d’impureses aplicats a oligonucle\u00f2tids, capacitats que ara estan totalment disponibles per donar suport als projectes dels clients.<\/strong><\/span><\/p>\n

Per als socis que desenvolupen f\u00e0rmacs basats en oligonucle\u00f2tids, aquestes capacitats signifiquen un suport CMC m\u00e9s r\u00e0pid i fiable, des del desenvolupament inicial del m\u00e8tode fins a la sol\u00b7licitud reglament\u00e0ria.<\/span><\/p>\n

En definitiva, aquesta iniciativa refor\u00e7a la missi\u00f3 de Kymos Group: combinar l’excel\u00b7l\u00e8ncia cient\u00edfica, el compliment normatiu i la innovaci\u00f3 en les proves anal\u00edtiques<\/strong> , ajudant els nostres socis a oferir als pacients medicaments basats en oligonucle\u00f2tids m\u00e9s segurs i efica\u00e7os.<\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":8,"featured_media":24452,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[67],"class_list":["post-24446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca","tag-carles"],"acf":[],"yoast_head":"\nOligoXplorer: La nostra plataforma CMC per a oligonucle\u00f2tids terap\u00e8utics<\/title>\n<meta name=\"description\" content=\"M\u00e9s informaci\u00f3 sobre 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