{"id":40129,"date":"2026-06-12T08:26:19","date_gmt":"2026-06-12T06:26:19","guid":{"rendered":"https:\/\/kymos.com\/?p=40129"},"modified":"2026-06-12T09:55:01","modified_gmt":"2026-06-12T07:55:01","slug":"ich-q1-un-marc-consolidat-per-a-les-proves-destabilitat-de-productes-biologics-2","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/ich-q1-un-marc-consolidat-per-a-les-proves-destabilitat-de-productes-biologics-2\/","title":{"rendered":"Transfer\u00e8ncia de m\u00e8todes de caracteritzaci\u00f3 de part\u00edcules: de Mastersizer 2000 a 3000 i de Zetasizer Nano a Ultra"},"content":{"rendered":"

La descatalogaci\u00f3 del Mastersizer 2000 i la transici\u00f3 gradual de la s\u00e8rie Zetasizer Nano estan impulsant molts laboratoris farmac\u00e8utics a revisar com mantenen els m\u00e8todes validats de caracteritzaci\u00f3 de part\u00edcules. Per a molts laboratoris, l’actualitzaci\u00f3 a una plataforma amb suport \u00e9s ara inevitable, per\u00f2 garantir la continu\u00eftat de les dades i el compliment de les GMP requereix m\u00e9s que el simple reempla\u00e7ament de l’instrument. <\/span><\/p>\n

Instal\u00b7lar un nou analitzador \u00e9s relativament senzill. El veritable repte \u00e9s demostrar que les dades hist\u00f2riques dels lots, les especificacions de producte establertes i els par\u00e0metres validats continuen sent comparables. <\/span><\/p>\n

Per qu\u00e8 \u00e9s important la transfer\u00e8ncia de m\u00e8todes<\/strong><\/h2>\n

En un entorn GMP, l’instrument anal\u00edtic est\u00e0 estretament lligat al m\u00e8tode. Quan un instrument com el Mastersizer 2000 arriba al final del seu cicle de vida amb suport \u2014cosa que significa que no hi ha recanvis, ni servei t\u00e8cnic, i que augmenten les vulnerabilitats del programari\u2014, s’introdueix un risc regulatori i de negoci inacceptable. <\/span><\/p>\n

Tanmateix, el canvi a una nova plataforma presenta els seus propis reptes. Sense una transfer\u00e8ncia de m\u00e8tode robusta, els laboratoris s’enfronten a: <\/span><\/p>\n

Discontinu\u00eftat de les dades:<\/strong> la comparabilitat hist\u00f2rica es perd si el nou instrument mesura la mateixa mostra de manera diferent.<\/span><\/p>\n

Incompliment d’especificacions:<\/strong> les especificacions de control de qualitat establertes poden generar sobtadament resultats fora d’especificaci\u00f3 (OOS) a la nova plataforma.<\/span><\/p>\n

Redesenvolupament cost\u00f3s:<\/strong> si no es transfereix el m\u00e8tode correctament, es poden produir mesos de redesenvolupament i revalidaci\u00f3 de m\u00e8todes innecessaris.<\/span><\/p>\n

L’objectiu d’una transfer\u00e8ncia reeixida \u00e9s la continu\u00eftat: mantenir els m\u00e8todes validats, preservar les dades hist\u00f2riques i conservar la confian\u00e7a regulat\u00f2ria sense haver de comen\u00e7ar de zero.<\/span><\/p>\n

Per qu\u00e8 instruments equivalents no sempre generen resultats equivalents<\/strong><\/h2>\n

Una idea err\u00f2nia comuna \u00e9s que executar un m\u00e8tode validat en un instrument m\u00e9s nou i t\u00e8cnicament superior donar\u00e0 resultats id\u00e8ntics de distribuci\u00f3 de la mida de part\u00edcula (PSD) o de dispersi\u00f3 de llum din\u00e0mica (DLS). En realitat, dos instruments equivalents sovint produiran dades diferents per a la mateixa mostra exacta. <\/span><\/p>\n

Les plataformes d’instruments modernes difereixen no nom\u00e9s en el maquinari, sin\u00f3 tamb\u00e9 en la manera com s’adquireixen, es processen i s’interpreten les dades de mesura.<\/span><\/p>\n

Disseny \u00f2ptic i geometria del detector:<\/strong> les plataformes m\u00e9s noves solen disposar de matrius de detectors millorades i rangs de mesura ampliats. Per exemple, el Mastersizer 3000 utilitza un disseny \u00f2ptic plegat i un sistema de doble longitud d’ona (l\u00e0ser vermell i LED blau) que capta la dispersi\u00f3 submicrom\u00e8trica de manera diferent al disseny de l’antic Mastersizer 2000. <\/span><\/p>\n

Presentaci\u00f3 de la mostra:<\/strong> les difer\u00e8ncies en els mecanismes de dispersi\u00f3 per via humida, les velocitats d’agitaci\u00f3, l’aplicaci\u00f3 d’ultrasons i la din\u00e0mica del flux de pols seca fan que l’estat f\u00edsic de les part\u00edcules durant la mesura pugui variar entre els models antics i els nous.<\/span><\/p>\n

Algoritmes de programari:<\/strong> la manera com les dades brutes de dispersi\u00f3 de llum es tradueixen en una distribuci\u00f3 de mida de part\u00edcula dep\u00e8n de models matem\u00e0tics complexos. Les versions actualitzades del programari i els algoritmes de processament m\u00e9s r\u00e0pids poden gestionar aquests c\u00e0lculs de manera diferent, influint en els resultats finals. <\/span><\/p>\n

Sensibilitat de mesura:<\/strong> les plataformes DLS actualitzades, com el Zetasizer Ultra, introdueixen la dispersi\u00f3 de llum din\u00e0mica multiangle (MADLS), capturant les dades de manera diferent a la tecnologia de dispersi\u00f3 posterior no invasiva (NIBS) utilitzada en l’antic Nano ZS.<\/span><\/p>\n

A causa d’aquestes variables, \u00e9s necessari un proc\u00e9s de transfer\u00e8ncia dirigit per experts per alinear els resultats anal\u00edtics, en lloc de simplement copiar els par\u00e0metres d’un instrument a un altre.<\/span><\/p>\n

Bones pr\u00e0ctiques per a una transfer\u00e8ncia de m\u00e8todes reeixida<\/strong><\/h2>\n

Una transfer\u00e8ncia de m\u00e8tode robusta hauria de seguir els principis de gesti\u00f3 del cicle de vida descrits a la guia ICH Q14, anant m\u00e9s enll\u00e0 de la simple introducci\u00f3 de par\u00e0metres cap a un proc\u00e9s de pont cient\u00edficament justificat.<\/span><\/p>\n

Avaluaci\u00f3 de riscos:<\/strong> identificar quines especificacions de producte s\u00f3n m\u00e9s sensibles als canvis d’instrument abans que comenci la transfer\u00e8ncia.<\/span><\/p>\n

Revisi\u00f3 del m\u00e8tode i optimitzaci\u00f3 de par\u00e0metres:<\/strong> traduir acuradament par\u00e0metres com els l\u00edmits d’obscuriment, les velocitats d’agitaci\u00f3 i les durades de mesura per adaptar-los a les caracter\u00edstiques f\u00edsiques del nou sistema i les seves unitats de dispersi\u00f3.<\/span><\/p>\n

Verificaci\u00f3:<\/strong> realitzar proves comparatives utilitzant mostres id\u00e8ntiques per avaluar la precisi\u00f3, la repetibilitat i la robustesa del m\u00e8tode transferit.<\/span><\/p>\n

Comparaci\u00f3 estad\u00edstica:<\/strong> utilitzar enfocaments estad\u00edstics adequats per demostrar l’equival\u00e8ncia entre les dades hist\u00f2riques generades en l’instrument antic i les dades produ\u00efdes per la nova plataforma.<\/span><\/p>\n

Documentaci\u00f3:<\/strong> proporcionar la documentaci\u00f3 rigorosa de GMP necess\u00e0ria per donar suport a les inspeccions i auditories regulat\u00f2ries.<\/span><\/p>\n

Dos escenaris del m\u00f3n real en la caracteritzaci\u00f3 de part\u00edcules<\/strong><\/h2>\n

Tot i que aquests principis s’apliquen \u00e0mpliament a totes les t\u00e8cniques de caracteritzaci\u00f3 de part\u00edcules, actualment hi ha dues transicions d’especial rellev\u00e0ncia per als laboratoris farmac\u00e8utics.<\/span><\/p>\n

    \n
  1. \n

    La necessitat immediata: de Mastersizer 2000 a Mastersizer 3000<\/strong><\/h2>\n<\/li>\n<\/ol>\n

    A partir del 2025, les an\u00e0lisis de difracci\u00f3 l\u00e0ser realitzades amb el Malvern Mastersizer 2000 ja no tindran suport sota GMP. Aix\u00f2 representa un risc cr\u00edtic i immediat per als laboratoris de control de qualitat farmac\u00e8utic. Les organitzacions que depenen de l’MS 2000 han de transferir els seus m\u00e8todes validats de dispersi\u00f3 per via humida i seca al Mastersizer 3000 per mantenir el compliment operatiu i evitar interrupcions en les proves rutin\u00e0ries. <\/p>\n

      \n
    1. \n

      Preparaci\u00f3 proactiva per al futur: de Zetasizer Nano a Ultra<\/strong><\/h2>\n<\/li>\n<\/ol>\n

      Les mateixes consideracions s’apliquen als laboratoris que planegen la transici\u00f3 de la s\u00e8rie Zetasizer Nano al Zetasizer Ultra. Tot i que encara existeix suport per al Nano ZS, la plataforma s’apropa al final del seu cicle de vida. Planificar aquesta transici\u00f3 amb antelaci\u00f3 permet als laboratoris preservar la continu\u00eftat de les dades a llarg termini i beneficiar-se de capacitats anal\u00edtiques millorades, sense la pressi\u00f3 d’una migraci\u00f3 urgent. <\/p>\n

      Com Kymos Group dona suport al proc\u00e9s<\/strong><\/h2>\n

      Gestionar l’actualitzaci\u00f3 d’un instrument sense comprometre les dades hist\u00f2riques requereix una experi\u00e8ncia especialitzada. Amb una \u00e0mplia experi\u00e8ncia en an\u00e0lisi de dispersi\u00f3 per via humida i seca, aix\u00ed com en mesures de DLS i potencial zeta, els nostres laboratoris han donat suport amb \u00e8xit a la transfer\u00e8ncia de centenars de m\u00e8todes anal\u00edtics per a clients farmac\u00e8utics. <\/p>\n

      Oferim un suport integral durant tot el proc\u00e9s: des de l’avaluaci\u00f3 inicial de riscos i l’optimitzaci\u00f3 de par\u00e0metres fins a la verificaci\u00f3 del m\u00e8tode i la documentaci\u00f3 de validaci\u00f3 GMP alineada amb els principis de la guia ICH Q14.<\/p>\n

      Planificar la transici\u00f3 abans que finalitzi el suport de l’instrument ofereix als laboratoris l’oportunitat de transferir els m\u00e8todes de manera controlada i cient\u00edficament s\u00f2lida, mantenint la continu\u00eftat de les dades i el compliment de les GMP.<\/p>\n

      Poseu-vos en contacte amb l’equip de Kymos Group per parlar de com podem donar suport a la vostra propera transfer\u00e8ncia de m\u00e8todes de caracteritzaci\u00f3 de part\u00edcules: https:\/\/kymos.com\/contact\/<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":8,"featured_media":40151,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[],"class_list":["post-40129","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca"],"acf":[],"yoast_head":"\nTransfer\u00e8ncia de m\u00e8todes Mastersizer 2000 a 3000 i Zetasizer<\/title>\n<meta name=\"description\" content=\"Esteu actualitzant des d'un Mastersizer 2000 o un Zetasizer Nano? 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