{"id":2480,"date":"2023-11-09T17:23:33","date_gmt":"2023-11-09T15:23:33","guid":{"rendered":"https:\/\/jjpbiologics.com\/?p=2480"},"modified":"2024-02-21T14:33:31","modified_gmt":"2024-02-21T12:33:31","slug":"zapytanie-z-dnia-09-11-2023","status":"publish","type":"post","link":"https:\/\/jjpbiologics.com\/pl\/zapytanie-z-dnia-09-11-2023\/","title":{"rendered":"Zapytanie z dnia 09\/11\/2023"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2480\" class=\"elementor elementor-2480\" data-elementor-settings=\"[]\">\n\t\t\t\t\t\t<div class=\"elementor-inner\">\n\t\t\t\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a6c4773 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a6c4773\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4540d693 sc_inner_width_none sc_layouts_column_icons_position_left\" data-id=\"4540d693\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-546d1720 elementor-widget elementor-widget-text-editor\" data-id=\"546d1720\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\"><p><span dir=\"ltr\" style=\"font-size: 16px;\"> 2311_T01_DLY_01 Batch R<\/span><\/p><ul><li><span style=\"font-size: 16px;\">W zwi\u0105zku z realizacj\u0105 projektu rozwoju kandydata na lek o tytule \u201eDevelopment of first-in-class antibody therapy for treatment of the ultra-rare LABD indication as well as for pulmonary and autoimmune diseases with IgA mediated pathology, using Companion Diagnostics (CDx) patient stratification for treatment with the JJP-1212&#8243; w ramach konkursu Rozw\u00f3j medycyny celowanej lub personalizowanej na bazie terapii kom\u00f3rkowych lub produkt\u00f3w bia\u0142kowych, organizowanego przez Agencj\u0119 Bada\u0144 Medycznych, og\u0142aszamy zapytanie ofertowe na realizacj\u0119 <\/span><b style=\"font-size: 16px;\">us\u0142ugi <\/b><span style=\"color: #121619;\"><span style=\"font-size: 16px;\"><b>zwolnienia partii IMP w celu wsparcia procesu opracowywania lek\u00f3w w programie terapeutycznego przeciwcia\u0142a monoklonalnego JJP-1212\u00a0<\/b><\/span><\/span><b>(ang.\u00a0<\/b><span style=\"color: #121619;\"><b>the batch release of IMP to support the drug development process in JJP-1212 therapeutic monoclonal antibody program<\/b><\/span><b>).<\/b><\/li><li style=\"font-size: 16px;\">Szczeg\u00f3\u0142y zapytania zostan\u0105 przekazane ka\u017cdorazowo po podpisaniu umowy o zachowaniu poufno\u015bci, w terminie 2 dni, lub po zg\u0142oszeniu si\u0119 podmiotu z\u00a0aktywn\u0105 umow\u0105 o zachowaniu poufno\u015bci. Wz\u00f3r umowy do pobrania\u00a0<a style=\"font-size: 16px; background-color: #ffffff;\" href=\"http:\/\/jjpbiologics.com\/wp-content\/uploads\/2023\/10\/2023.10.30_NDA_JJPBio_ENG_POL.docx\">LINK<\/a><span style=\"font-size: 16px;\">.<\/span><\/li><li style=\"font-size: 16px;\"><del><span style=\"font-size: 16px;\">Termin sk\u0142adania ofert:\u00a0<\/span>20.11.2023<\/del><\/li><li style=\"font-size: 16px;\"><del><span style=\"font-size: 16px;\">Termin sk\u0142adania ofert zosta\u0142 wyd\u0142u\u017cony do:\u00a0<\/span><span style=\"color: #121619;\">21.11.2023<\/span><\/del><\/li><li><span style=\"font-size: 16px;\">Pytania i kontakt tw zwi\u0105zku z zapytaniem prosz\u0119 kierowa\u0107 na adres:\u00a0<\/span><img decoding=\"async\" style=\"font-family: inherit; font-style: inherit; font-weight: inherit;\" 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alt=\"\" \/><\/li><li><strong>Post\u0119powanie zosta\u0142o anulowane<\/strong><\/li><\/ul><p><span style=\"font-family: Hind, sans-serif; font-size: 15px; font-style: normal; font-weight: 400;\">Otrzymane pytania dotycz\u0105ce specyfikacji zam\u00f3wienia:<\/span><\/p><ol><li style=\"font-size: 15px; margin-top: 0px;\">Certification of finished Investigational Medicinal Product and <b>release of investigational medicinal bulk product<\/b>. Do I understand correctly that this is the release of bare vials for repackaging, based on the CoC from the manufacturer?<br \/><b style=\"margin-bottom: 0px;\">Odpowied\u017a:<\/b>\u00a0This RFP refers to release of finished IMP for clinical trial use (after IMPD approval). Bulk refers to single release of single batch of finished IMP (all vials of IMP will be released at once).<\/li><\/ol><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>2311_T01_DLY_01 Batch R W zwi\u0105zku z realizacj\u0105 projektu rozwoju kandydata na lek o tytule \u201eDevelopment of first-in-class antibody therapy for&hellip;<\/p>","protected":false},"author":990005,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"elementor_theme","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[64],"tags":[62],"class_list":["post-2480","post","type-post","status-publish","format-standard","hentry","category-zapytania","tag-jjp1212"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - 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Wz\u00f3r umowy do pobrania\u00a0<a style=\"font-size: 16px;background-color: #ffffff\" href=\"http:\/\/jjpbiologics.com\/wp-content\/uploads\/2023\/10\/2023.10.30_NDA_JJPBio_ENG_POL.docx\">LINK<\/a>.<\/li>\n<li style=\"font-size: 16px\"><del>Termin sk\u0142adania ofert:\u00a020.11.2023<\/del><\/li>\n<li style=\"font-size: 16px\"><del>Termin sk\u0142adania ofert zosta\u0142 wyd\u0142u\u017cony do:\u00a021.11.2023<\/del><\/li>\n<li>Pytania i kontakt tw zwi\u0105zku z zapytaniem prosz\u0119 kierowa\u0107 na adres:\u00a0<img style=\"font-family: inherit;font-style: inherit;font-weight: inherit\" 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alt=\"\" \/><\/li>\n<li><strong>Post\u0119powanie zosta\u0142o anulowane<\/strong><\/li>\n<\/ul>\n<p>Otrzymane pytania dotycz\u0105ce specyfikacji zam\u00f3wienia:<\/p>\n<ol>\n<li style=\"font-size: 15px;margin-top: 0px\">Certification of finished Investigational Medicinal Product and <b>release of investigational medicinal bulk product<\/b>. Do I understand correctly that this is the release of bare vials for repackaging, based on the CoC from the manufacturer?<br \/><b style=\"margin-bottom: 0px\">Odpowied\u017a:<\/b>\u00a0This RFP refers to release of finished IMP for clinical trial use (after IMPD approval). Bulk refers to single release of single batch of finished IMP (all vials of IMP will be released at once).<\/li>\n<\/ol>\n","comment_info":"No Comments","_links":{"self":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts\/2480","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/users\/990005"}],"replies":[{"embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/comments?post=2480"}],"version-history":[{"count":0,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts\/2480\/revisions"}],"wp:attachment":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/media?parent=2480"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/categories?post=2480"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/tags?post=2480"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}