{"id":58051,"date":"2023-04-06T14:17:29","date_gmt":"2023-04-06T12:17:29","guid":{"rendered":"https:\/\/www.oncomed.cz\/?post_type=studies&p=58051"},"modified":"2023-04-06T14:17:32","modified_gmt":"2023-04-06T12:17:32","slug":"jake-jsou-vyhody-vyuziti-smluvni-spolecnosti-pro-vyrobu-leciv","status":"publish","type":"studies","link":"https:\/\/www.oncomed.cz\/cs\/blog\/jake-jsou-vyhody-vyuziti-smluvni-spolecnosti-pro-vyrobu-leciv\/","title":{"rendered":"Jak\u00e9 jsou v\u00fdhody vyu\u017eit\u00ed smluvn\u00ed spole\u010dnosti pro v\u00fdrobu l\u00e9\u010div?"},"content":{"rendered":"
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Contract manufacturing je obchodn\u00ed model, kter\u00fd v posledn\u00edch letech z\u00edsk\u00e1v\u00e1 na popularit\u011b. Spole\u010dnosti specializuj\u00edc\u00ed se na smluvn\u00ed v\u00fdrobu jsou st\u00e1le v\u00edce vyhled\u00e1v\u00e1ny farmaceutick\u00fdmi a biotechnologick\u00fdmi spole\u010dnostmi, kter\u00e9 hledaj\u00ed efektivn\u00ed a cenov\u011b dostupn\u00e9 zp\u016fsoby, jak uv\u00e9st sv\u00e9 produkty na trh.<\/p>\n

Zde jsou n\u011bkter\u00e9 v\u00fdhody pou\u017eit\u00ed CDMO pro v\u00fdvoj a v\u00fdrobu l\u00e9\u010div:<\/p>\n

    \n
  1. P\u0159\u00edstup k odborn\u00e9mu know-how<\/li>\n<\/ol>\n

    CDMO maj\u00ed vysoce kvalifikovan\u00fd person\u00e1l s odborn\u00fdmi znalostmi v \u0161irok\u00e9 \u0161k\u00e1le oblast\u00ed, v\u010detn\u011b chemie, biologie, v\u00fdvoje formulac\u00ed a v\u00fdroby. Tyto specializovan\u00e9 znalosti a zku\u0161enosti jsou neoceniteln\u00e9 p\u0159i p\u0159ekon\u00e1v\u00e1n\u00ed technick\u00fdch v\u00fdzev a urychlov\u00e1n\u00ed procesu v\u00fdvoje l\u00e9\u010div.<\/p>\n

      \n
    1. \u00daspory n\u00e1klad\u016f<\/li>\n<\/ol>\n

      Outsourcing v\u00fdvoje l\u00e9\u010div a jejich v\u00fdroby CDMO je cenov\u011b efektivn\u00ed, proto\u017ee eliminuje pot\u0159ebu investovat spole\u010dnost\u00ed do drah\u00e9ho vybaven\u00ed, za\u0159\u00edzen\u00ed a person\u00e1lu.<\/p>\n

        \n
      1. Flexibilita<\/li>\n<\/ol>\n

        Od v\u00fdvoje ve f\u00e1zi ran\u00e9ho v\u00fdvoje a\u017e po komer\u010dn\u00ed v\u00fdrobu \u2013 d\u00edky tomu si mohou spole\u010dnosti vybrat slu\u017eby, kter\u00e9 nejl\u00e9pe vyhovuj\u00ed jejich pot\u0159eb\u00e1m, a m\u011bnit rozsah v\u00fdroby podle pot\u0159eby.<\/p>\n

          \n
        1. Dodr\u017eov\u00e1n\u00ed kvality<\/li>\n<\/ol>\n

          CDMO jsou podrobeny p\u0159\u00edsn\u00fdm standard\u016fm kvality a regulace, co\u017e pom\u00e1h\u00e1 zajistit, \u017ee produkty jsou vyr\u00e1b\u011bny za nejvy\u0161\u0161\u00edch standard\u016f bezpe\u010dnosti a \u00fa\u010dinnosti.<\/p>\n

          V oblasti cytotoxick\u00fdch onkologick\u00fdch produkt\u016f m\u016f\u017ee b\u00fdt vyu\u017eit\u00ed smluvn\u00ed spole\u010dnosti zvl\u00e1\u0161t\u011b v\u00fdhodn\u00e9. Cytotoxick\u00e9 onkologick\u00e9 produkty se pou\u017e\u00edvaj\u00ed k l\u00e9\u010db\u011b rakoviny a jsou navr\u017eeny k zab\u00edjen\u00ed rakovinn\u00fdch bun\u011bk. Nicm\u00e9n\u011b mohou b\u00fdt tak\u00e9 \u0161kodliv\u00e9 pro zdrav\u00e9 bu\u0148ky v t\u011ble. V\u00fdroba cytotoxick\u00fdch onkologick\u00fdch produkt\u016f vy\u017eaduje specializovan\u00e1 za\u0159\u00edzen\u00ed a vybaven\u00ed, stejn\u011b jako kvalifikovan\u00fd person\u00e1l, kter\u00fd um\u00ed s\u00a0takov\u00fdmi l\u00e1tkami bezpe\u010dn\u011b pracovat.<\/p>\n

          Jako specializovan\u00e1 smluvn\u00ed v\u00fdvojov\u00e1 a v\u00fdrobn\u00ed organizace p\u0159in\u00e1\u0161\u00edme na\u0161i odbornost v oblasti steriln\u00edho zpracov\u00e1n\u00ed a aseptick\u00e9ho pln\u011bn\u00ed komplexn\u00edch formulac\u00ed. D\u00edky na\u0161emu modern\u00edmu v\u00fdrobn\u00ed za\u0159\u00edzen\u00ed a zku\u0161en\u00e9mu person\u00e1lu je zaji\u0161t\u011bno, \u017ee v\u00fdrobky jsou vyr\u00e1b\u011bny podle nejvy\u0161\u0161\u00edch standard\u016f kvality a bezpe\u010dnosti.<\/p>\n

          Na\u0161e nejmodern\u011bj\u0161\u00ed technologie p\u0159edstavuj\u00ed dv\u011b v\u00fdrobn\u00ed linky zam\u011b\u0159en\u00e9 na v\u00fdrobu cytostatick\u00fdch injekc\u00ed pro l\u00e9\u010dbu onkologick\u00fdch onemocn\u011bn\u00ed.\u00a0Biomolekuly\u00a0jsou zpracov\u00e1v\u00e1ny pomoc\u00ed jednor\u00e1zov\u00fdch syst\u00e9m\u016f v kombinaci s izol\u00e1torem na v\u00fdrobn\u00ed lince 2.<\/p>\n

          Krom\u011b slu\u017eby Fill & Finish, kterou uplat\u0148ujeme p\u0159i v\u00fdrob\u011b velk\u00fdch molekul, nab\u00edz\u00edme tak\u00e9 tzv. end-to-end \u0159e\u0161en\u00ed, kter\u00e1 zahrnuj\u00ed v\u00fdvoj formulace, optimalizaci proces\u016f, v\u00fdvoj analytick\u00fdch metod a testov\u00e1n\u00ed stability. Poskytov\u00e1n\u00edm komplexn\u00edho spektra slu\u017eeb zaji\u0161\u0165ujeme, \u017ee na\u0161i z\u00e1kazn\u00edci mohou sv\u00e9 v\u00fdrobky uv\u00e9st na trh v\u00a0co nejkrat\u0161\u00edm \u010dase.<\/p>\n

          Z\u00e1v\u011brem lze \u0159\u00edci, \u017ee vyu\u017eit\u00ed CDMO pro cytotoxick\u00e9 onkologick\u00e9 v\u00fdrobky m\u016f\u017ee b\u00fdt pro farmaceutick\u00e9 a biotechnologick\u00e9 spole\u010dnosti velmi prosp\u011b\u0161n\u00e9. Outsourcov\u00e1n\u00edm v\u00fdrobn\u00edho procesu specializovan\u00e9 firm\u011b se mohou spole\u010dnosti zam\u011b\u0159it na sv\u00e9 kl\u00ed\u010dov\u00e9 kompetence. Vzhledem k tomu, \u017ee se farmaceutick\u00fd pr\u016fmysl neust\u00e1le vyv\u00edj\u00ed, je pravd\u011bpodobn\u00e9, \u017ee role smluvn\u00edch v\u00fdrobn\u00edch organizac\u00ed bude je\u0161t\u011b d\u016fle\u017eit\u011bj\u0161\u00ed, proto\u017ee umo\u017en\u00ed spole\u010dnostem efektivn\u011b uv\u00e1d\u011bt na trh nov\u00e9 l\u00e9ky a terapie.<\/p>\n<\/div>\n<\/div>\n\n","protected":false},"author":3,"featured_media":0,"template":"","meta":{"_acf_changed":false,"advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories_studies":[13],"class_list":["post-58051","studies","type-studies","status-publish","hentry"],"acf":[],"aioseo_notices":[],"featured_img":false,"coauthors":[],"author_meta":{"author_link":"https:\/\/www.oncomed.cz\/cs\/author\/jorova\/","display_name":"Zuzana Jorov\u00e1"},"relative_dates":{"created":"Posted 3 roky ago","modified":"Updated 3 roky ago"},"absolute_dates":{"created":"Posted on 6. 4. 2023","modified":"Updated on 6. 4. 2023"},"absolute_dates_time":{"created":"Posted on 6. 4. 2023 14:17","modified":"Updated on 6. 4. 2023 14:17"},"featured_img_caption":"","tax_additional":{"categories_studies":{"linked":["\u010cl\u00e1nky<\/a>"],"unlinked":["\u010cl\u00e1nky<\/span>"],"slug":"categories_studies","name":"Kategorie blogu"},"translation_priority":{"linked":[],"unlinked":[],"slug":"translation_priority","name":"Translation Priorities"}},"series_order":"","_links":{"self":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/58051","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies"}],"about":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/types\/studies"}],"version-history":[{"count":2,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/58051\/revisions"}],"predecessor-version":[{"id":58053,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/58051\/revisions\/58053"}],"wp:attachment":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/media?parent=58051"}],"wp:term":[{"taxonomy":"categories_studies","embeddable":true,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/categories_studies?post=58051"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}