{"id":47968,"date":"2026-08-17T09:00:48","date_gmt":"2026-08-17T07:00:48","guid":{"rendered":"https:\/\/kymos.com\/?p=47968"},"modified":"2026-08-17T09:00:48","modified_gmt":"2026-08-17T07:00:48","slug":"control-microbiologic-de-productes-biologics-estrategies-dassaig","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/control-microbiologic-de-productes-biologics-estrategies-dassaig\/","title":{"rendered":"Control microbiol\u00f2gic de productes biol\u00f2gics: estrat\u00e8gies d’assaig"},"content":{"rendered":"

La seguretat microbiol\u00f2gica dels productes biol\u00f2gics \u00e9s un pas cr\u00edtic al llarg del desenvolupament, la fabricaci\u00f3 i l’alliberament de lots. Els productes biol\u00f2gics requereixen una estrat\u00e8gia d’assaig integral que verifiqui l’abs\u00e8ncia de contaminaci\u00f3 microbiana alhora que demostri el compliment dels requisits farmacopeics i reguladors internacionals. <\/span><\/p>\n

Una estrat\u00e8gia integral de control microbiol\u00f2gic \u00e9s essencial per avaluar els riscos potencials de contaminaci\u00f3 en les diferents etapes del desenvolupament i la fabricaci\u00f3 del producte. A Kymos Group, el nostre laboratori de microbiologia amb certificaci\u00f3 GMP dona suport a aquesta estrat\u00e8gia amb serveis de control de qualitat microbiol\u00f2gic per a productes biol\u00f2gics, ter\u00e0pies cel\u00b7lulars i g\u00e8niques, vacunes i altres productes farmac\u00e8utics est\u00e8rils i no est\u00e8rils. <\/span><\/p>\n

Un enfocament complet <\/strong><\/span><\/h2>\n

La seguretat del producte dep\u00e8n d’una combinaci\u00f3 d’assaigs que avaluen els riscos de contaminaci\u00f3 en les diferents etapes de fabricaci\u00f3 i control de qualitat.<\/span><\/p>\n

Aquestes avaluacions microbiol\u00f2giques sovint es realitzen juntament amb les an\u00e0lisis de control de qualitat fisicoqu\u00edmics i anal\u00edtics, proporcionant un enfocament integrat per a la caracteritzaci\u00f3 del producte i l’alliberament de lots.<\/span><\/p>\n

C\u00e0rrega microbiana (Bioburden) <\/strong><\/span><\/h2>\n

(D’acord amb Ph. Eur. 2.6.12; USP <1119>) <\/em><\/span><\/p>\n

L’assaig de c\u00e0rrega microbiana (bioburden) determina la poblaci\u00f3 total de microorganismes viables presents en mat\u00e8ries primeres, API o productes acabats abans de l’esterilitzaci\u00f3 o el processament as\u00e8ptic. \u00c9s una mesura de control de qualitat cr\u00edtica utilitzada per avaluar l’estat microbiol\u00f2gic dels processos de fabricaci\u00f3. El monitoratge rutinari dels nivells de bioburden garanteix que els processos es mantinguin sota control i dona suport a la validaci\u00f3 i l’efic\u00e0cia continuada dels procediments d’esterilitzaci\u00f3. <\/span><\/p>\n

Assaig de l\u00edmits microbiol\u00f2gics: TAMC, TYMC i microorganismes espec\u00edfics <\/strong><\/span><\/h2>\n

(D’acord amb Ph. Eur. 2.6.12\/Ph. Eur. 2.6.13; USP <61>\/ USP <62>) <\/em><\/span><\/p>\n

A difer\u00e8ncia de l’assaig de bioburden, l’assaig de l\u00edmits microbiol\u00f2gics s’utilitza per a productes farmac\u00e8utics no est\u00e8rils per avaluar la qualitat microbiol\u00f2gica del producte i verificar que la poblaci\u00f3 microbiana es mant\u00e9 dins dels l\u00edmits acceptables definits per les farmacopees pertinents.<\/span><\/p>\n

L’assaig inclou:<\/span><\/p>\n

    \n
  • Recompte total de microorganismes aer\u00f2bics (TAMC): enumeraci\u00f3 de bacteris aer\u00f2bics.<\/span><\/li>\n
  • Recompte total de llevats i motlles (TYMC): enumeraci\u00f3 de llevats i fongs filamentosos.<\/span><\/li>\n
  • Detecci\u00f3 de microorganismes espec\u00edfics, com ara Escherichia coli<\/em>, Pseudomonas aeruginosa<\/em>, Staphylococcus aureus<\/em>, Salmonella<\/em> spp., Candida albicans<\/em> o bacteris gramnegatius tolerants a la bilis, segons la categoria del producte i la via d’administraci\u00f3.<\/span><\/li>\n<\/ul>\n

    Assaig d’esterilitat <\/strong><\/span><\/h2>\n

    (D’acord amb Ph. Eur. 2.6.1, USP <71>) <\/em><\/span><\/p>\n

    L’assaig d’esterilitat confirma l’abs\u00e8ncia de microorganismes viables en productes destinats a ser est\u00e8rils. Realitzat en condicions as\u00e8ptiques estrictament controlades, \u00e9s un assaig de control de qualitat cr\u00edtic i un requisit clau per a l’alliberament de lots de productes biol\u00f2gics est\u00e8rils i productes injectables. <\/span><\/p>\n

    Per a l’assaig de productes est\u00e8rils, el nostre laboratori de microbiologia inclou una sala blanca dedicada equipada amb dos a\u00eflladors de 4 guants, una bomba Steritest\u00ae Symbio\u00ae i un sistema de biodecontaminaci\u00f3 per H\u2082O\u2082. Aquesta tecnologia avan\u00e7ada d’a\u00eflladors minimitza el risc de contaminaci\u00f3 externa alhora que garanteix un assaig d’esterilitat fiable d’acord amb els requisits farmacopeics. <\/span><\/p>\n

    Assaig d’endotoxines bacterianes <\/strong><\/span><\/h2>\n

    (D’acord amb Ph. Eur. 2.6.14; USP <85> i <86>) <\/em><\/span><\/p>\n

    Les endotoxines bacterianes, originades a la membrana externa dels bacteris gramnegatius, poden romandre presents fins i tot despr\u00e9s d’haver eliminat els microorganismes. Si s’administren als pacients, les endotoxines poden induir reaccions pirog\u00e8niques greus, fet que fa que la seva detecci\u00f3 sigui essencial per als productes m\u00e8dics, especialment els productes biol\u00f2gics parenterals. <\/span><\/p>\n

    La selecci\u00f3 d’un m\u00e8tode de detecci\u00f3 d’endotoxines adequat dep\u00e8n de les caracter\u00edstiques del producte i dels requisits aplicables. Hi ha m\u00faltiples metodologies validades disponibles, incloent-hi: <\/span><\/p>\n

      \n
    • LAL cromog\u00e8nic cin\u00e8tic<\/span><\/li>\n
    • LAL turbidim\u00e8tric cin\u00e8tic<\/span><\/li>\n
    • Assaig de gelificaci\u00f3 (Gel-clot)<\/span><\/li>\n
    • Reactiu de cascada recombinant (rCR)<\/span><\/li>\n<\/ul>\n

      Detecci\u00f3 r\u00e0pida de micoplasmes mitjan\u00e7ant qPCR: detecci\u00f3 preco\u00e7 per a millors decisions<\/strong><\/p>\n

      A m\u00e9s dels m\u00e8todes microbiol\u00f2gics convencionals, els enfocaments moleculars poden proporcionar una detecci\u00f3 m\u00e9s r\u00e0pida de contaminants espec\u00edfics. La detecci\u00f3 r\u00e0pida de micoplasmes mitjan\u00e7ant qPCR \u00e9s especialment valuosa per al monitoratge de cultius cel\u00b7lulars, bancs de c\u00e8l\u00b7lules, vectors virals i altres productes biol\u00f2gics, permetent la detecci\u00f3 preco\u00e7 de la contaminaci\u00f3. <\/span><\/p>\n

      A Kymos, disposem de detecci\u00f3 de micoplasmes basada en qPCR que compleix les GLP per donar suport a les activitats de desenvolupament.<\/span><\/p>\n

      En comparaci\u00f3 amb els m\u00e8todes tradicionals basats en cultius, la qPCR ofereix:<\/span><\/p>\n

        \n
      • Resultats en hores en lloc de diverses setmanes<\/span><\/li>\n
      • Alta sensibilitat i especificitat anal\u00edtica<\/span><\/li>\n
      • Detecci\u00f3 preco\u00e7 de la contaminaci\u00f3<\/span><\/li>\n<\/ul>\n

        L’adopci\u00f3 creixent de les t\u00e8cniques d’amplificaci\u00f3 d’\u00e0cids nucleics (NAT), inclosa la qPCR, es reflecteix en les guies farmacopeiques actuals. El cap\u00edtol revisat de la Farmacopea Europea \u201c2.6.7 Micoplasmes\u201d<\/em> reconeix els m\u00e8todes validats basats en NAT com a part del marc regulador per a la detecci\u00f3 de micoplasmes, mentre que el nou \u201dUSP <77> Proves d’amplificaci\u00f3 d’\u00e0cids nucleics per a micoplasmes\u201d <\/em>proporciona orientaci\u00f3 per a la validaci\u00f3 i aplicaci\u00f3 de m\u00e8todes NAT qualitatius. Aquestes revisions destaquen l’acceptaci\u00f3 creixent de les tecnologies basades en PCR per a la detecci\u00f3 de micoplasmes quan es validen adequadament per al seu \u00fas previst. <\/span><\/p>\n

        Serveis integrats de microbiologia GMP per a productes biol\u00f2gics<\/strong><\/span><\/h2>\n

        Garantir la seguretat microbiol\u00f2gica dels productes biol\u00f2gics requereix m\u00e9s d’un \u00fanic assaig. La combinaci\u00f3 adequada de m\u00e8todes microbiol\u00f2gics i moleculars dep\u00e8n del producte, el proc\u00e9s de fabricaci\u00f3, l’etapa de desenvolupament i els requisits reguladors aplicables. <\/span><\/p>\n

        El nostre laboratori de microbiologia combina instal\u00b7lacions d’\u00faltima generaci\u00f3, personal altament especialitzat i una \u00e0mplia experi\u00e8ncia reguladora per donar suport als fabricants al llarg del cicle de vida del producte, des del desenvolupament del proc\u00e9s i la transfer\u00e8ncia de tecnologia fins a la validaci\u00f3 de m\u00e8todes, els estudis d’estabilitat i l’alliberament de lots comercials.<\/span><\/p>\n

        Aquest enfocament integrat ajuda a garantir que els riscos microbiol\u00f2gics s’avaluen, es monitoren i es controlen efica\u00e7ment, alhora que es dona suport al compliment dels requisits internacionals de GMP, l’alliberament fiable de productes i, en \u00faltima inst\u00e0ncia, la seguretat del pacient.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

        La seguretat microbiol\u00f2gica dels productes biol\u00f2gics \u00e9s un pas cr\u00edtic […]<\/p>\n","protected":false},"author":8,"featured_media":47903,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[],"class_list":["post-47968","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca"],"acf":[],"yoast_head":"\nControl microbiol\u00f2gic de productes biol\u00f2gics: estrat\u00e8gies d'assaig | Kymos<\/title>\n<meta name=\"description\" content=\"Obtingueu informaci\u00f3 sobre les an\u00e0lisis microbiol\u00f2giques per a productes biol\u00f2gics, incloent-hi la c\u00e0rrega microbiana (bioburden), els l\u00edmits microbiol\u00f2gics, l'esterilitat, les endotoxines i la detecci\u00f3 r\u00e0pida de micoplasmes mitjan\u00e7ant qPCR.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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