{"id":4956,"date":"2024-05-23T05:31:56","date_gmt":"2024-05-23T05:31:56","guid":{"rendered":"https:\/\/pfanstiehl.com\/?post_type=solutions&#038;p=4956"},"modified":"2024-08-07T16:03:14","modified_gmt":"2024-08-07T16:03:14","slug":"fabrication-dapi-personnalisees","status":"publish","type":"solutions","link":"https:\/\/pfanstiehl.com\/fr\/solutions\/fabrication-dapi-personnalisees\/","title":{"rendered":"Fabrication d\u2019API personnalis\u00e9es"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4956\" class=\"elementor elementor-4956 elementor-648\" data-elementor-post-type=\"solutions\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3852b7a8 e-flex e-con-boxed e-con e-parent\" data-id=\"3852b7a8\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-17da37a0 e-flex e-con-boxed e-con e-child\" data-id=\"17da37a0\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-53d348fe elementor-widget elementor-widget-heading\" data-id=\"53d348fe\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Services de fabrication d\u2019ingr\u00e9dients pharmaceutiques actifs personnalis\u00e9s de Pfanstiehl<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4d91ec89 elementor-widget elementor-widget-text-editor\" data-id=\"4d91ec89\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>Avec une longue exp\u00e9rience r\u00e9ussie dans la fabrication d\u2019ingr\u00e9dients pharmaceutiques actifs (API) personnalis\u00e9s, Pfanstiehl s\u2019est impos\u00e9 comme un partenaire de confiance engag\u00e9 \u00e0 fournir des solutions adapt\u00e9es aux besoins uniques de nos clients. Notre histoire est riche en innovation et en excellence, couvrant des d\u00e9cennies d\u2019exp\u00e9rience dans le soutien \u00e0 l\u2019industrie pharmaceutique. Chez Pfanstiehl, nous comprenons l\u2019importance cruciale de favoriser des partenariats solides et d\u2019assurer la satisfaction du client \u00e0 chaque \u00e9tape du processus de fabrication. De la conception du produit \u00e0 la fourniture sur le march\u00e9, nous nous engageons \u00e0 fournir un support complet qui d\u00e9passe les attentes.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-829744a e-flex e-con-boxed e-con e-child\" data-id=\"829744a\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-36919c26 elementor-widget elementor-widget-image\" data-id=\"36919c26\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"http:\/\/localhost\/pfanstiehl\/wp-content\/uploads\/2024\/05\/Custom-API.png\" title=\"\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-908b976 e-flex e-con-boxed e-con e-parent\" data-id=\"908b976\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-effa298 elementor-widget elementor-widget-text-editor\" data-id=\"effa298\" 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\t\t<p>Lorsque vous vous associez \u00e0 Pfanstiehl pour la fabrication d\u2019API personnalis\u00e9s, vous travaillez c\u00f4te \u00e0 c\u00f4te avec nos scientifiques chevronn\u00e9s poss\u00e9dant une vaste expertise en chimie et ayant fait leurs preuves dans le soutien de diverses \u00e9tapes des programmes de d\u00e9veloppement clinique et de la fabrication \u00e0 l\u2019\u00e9chelle commerciale.  <\/p>\n<\/p>\n<p>Les services de d\u00e9veloppement et de fabrication d\u2019API personnalis\u00e9es de Pfanstiehl englobent un large \u00e9ventail de capacit\u00e9s adapt\u00e9es \u00e0 vos besoins sp\u00e9cifiques :<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-314b99ad solutions_content_box e-flex e-con-boxed e-con e-parent\" data-id=\"314b99ad\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-3ee1a41f e-flex e-con-boxed e-con e-child\" data-id=\"3ee1a41f\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-657bdcf3 elementor-widget elementor-widget-text-editor\" data-id=\"657bdcf3\" 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\t\t<h4>Soutien clinique en phase pr\u00e9coce et tardive :<\/h4>\n<p>Nos scientifiques fournissent un soutien complet tout au long des programmes de d\u00e9veloppement clinique de phase pr\u00e9coce et avanc\u00e9e, assurant une progression transparente des \u00e9tudes pr\u00e9cliniques aux essais cliniques.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-17b461a3 e-flex e-con-boxed e-con e-child\" data-id=\"17b461a3\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-226c80f3 elementor-widget elementor-widget-text-editor\" data-id=\"226c80f3\" 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\t\t<h4>Synth\u00e8se chimique en plusieurs \u00e9tapes :<\/h4>\n<p>Nous excellons dans la fabrication d\u2019API traditionnels et complexes, en utilisant des capacit\u00e9s de pointe pour ex\u00e9cuter des processus de synth\u00e8se chimique en plusieurs \u00e9tapes.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6ea1160c e-flex e-con-boxed e-con e-child\" data-id=\"6ea1160c\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-290f452 elementor-widget elementor-widget-text-editor\" data-id=\"290f452\" 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\t\t<h4>Flexibilit\u00e9 d\u2019\u00e9chelle :<\/h4>\n<p>De la fabrication \u00e0 l\u2019\u00e9chelle du laboratoire \u00e0 l\u2019\u00e9chelle du kilom\u00e8tre et \u00e0 l\u2019\u00e9chelle pilote, nous affinons et optimisons continuellement nos processus tout en fournissant une large gamme de quantit\u00e9s \u00e0 travers toutes les phases de d\u00e9veloppement.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6811337c e-flex e-con-boxed e-con e-child\" data-id=\"6811337c\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3e717095 elementor-widget elementor-widget-text-editor\" data-id=\"3e717095\" 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\t\t<h4>Soutien \u00e0 la fabrication commerciale :<\/h4>\nDu lancement du produit \u00e0 la fourniture sur le march\u00e9, Pfanstiehl s\u2019engage \u00e0 r\u00e9pondre aux besoins de fabrication commerciale. Avec les capacit\u00e9s actuelles, nous pouvons produire des quantit\u00e9s allant jusqu\u2019\u00e0 70 kg. Pfanstiehl assurera un approvisionnement constant et fiable pour r\u00e9pondre \u00e0 la demande du march\u00e9.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6a09f1f5 e-flex e-con-boxed e-con e-child\" data-id=\"6a09f1f5\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3ea35bd9 elementor-widget elementor-widget-text-editor\" data-id=\"3ea35bd9\" 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\t\t<h4>Conformit\u00e9 cGMP :<\/h4>\n<p>Les op\u00e9rations de Pfanstiehl respectent strictement les normes cGMP, refl\u00e9tant un engagement in\u00e9branlable envers la qualit\u00e9 et la conformit\u00e9 r\u00e9glementaire. Notre exp\u00e9rience \u00e9prouv\u00e9e d\u00e9montre notre engagement \u00e0 maintenir les normes les plus \u00e9lev\u00e9es d\u2019excellence en mati\u00e8re de fabrication.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7d4b112 e-flex e-con-boxed e-con e-child\" data-id=\"7d4b112\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67cdf096 elementor-widget elementor-widget-text-editor\" data-id=\"67cdf096\" 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\t\t<h4>Expertise de mise \u00e0 l\u2019\u00e9chelle :<\/h4>\n<p>Notre \u00e9quipe offre des capacit\u00e9s de mise \u00e0 l\u2019\u00e9chelle compl\u00e8tes, soutenues par une gamme compl\u00e8te de services analytiques. Nous privil\u00e9gions la flexibilit\u00e9, en garantissant une ex\u00e9cution rapide avec des rendements exceptionnels et une qualit\u00e9 sup\u00e9rieure \u00e0 chaque \u00e9tape du processus de mise \u00e0 l\u2019\u00e9chelle.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-69277092 e-flex e-con-boxed e-con e-child\" data-id=\"69277092\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-451af417 elementor-widget elementor-widget-text-editor\" data-id=\"451af417\" 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\t\t<h4>Du d\u00e9veloppement \u00e0 la commercialisation :<\/h4>\n<p>En tirant parti de nos vastes capacit\u00e9s de fabrication commerciale d\u2019API, nous guidons votre projet de mani\u00e8re transparente, du d\u00e9veloppement \u00e0 la mise \u00e0 l\u2019\u00e9chelle et \u00e0 la production commerciale. Notre approche int\u00e9gr\u00e9e rationalise la transition, minimise les risques et acc\u00e9l\u00e8re la mise sur le march\u00e9.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-62ad5d19 e-flex e-con-boxed e-con e-parent\" data-id=\"62ad5d19\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6a78aa11 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"6a78aa11\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 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var(--divider-color)}.elementor-widget-divider--separator-type-pattern{--divider-border-style:none}.elementor-widget-divider--separator-type-pattern.elementor-widget-divider--view-line .elementor-divider-separator,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:after,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:before,.elementor-widget-divider--separator-type-pattern:not([class*=elementor-widget-divider--view]) .elementor-divider-separator{width:100%;min-height:var(--divider-pattern-height);-webkit-mask-size:var(--divider-pattern-size) 100%;mask-size:var(--divider-pattern-size) 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class=\"elementor-element elementor-element-73437258 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"73437258\" 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\t\t<h3>Pr\u00e9sentation des capacit\u00e9s de fabrication de l\u2019API personnalis\u00e9e Pfanstiehl<\/h3>\n<ul>\n<li>\u00c9chelle de l\u2019installation de fabrication de m\u00e9dicaments API puissants : 1 \u00e0 70 kg<\/li>\n<li>Fabrication pilote : jusqu\u2019\u00e0 300 gallons de r\u00e9acteurs<\/li>\n<li>Installation antid\u00e9flagrante \u00e0 grande \u00e9chelle (2 000 gallons) pour le traitement avec des solvants inflammables<\/li>\n<li>Installation de r\u00e9cup\u00e9ration de solvants<\/li>\n<li>Processus de d\u00e9veloppement d\u2019API \u00e9prouv\u00e9 :<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>D\u00e9veloppement, mise \u00e0 l\u2019\u00e9chelle, optimisation et validation des proc\u00e9d\u00e9s<\/li>\n<li>Documentation cGMP<\/li>\n<li>M\u00e9thode d\u2019essai analytique et validation<\/li>\n<li>Tests de stabilit\u00e9 conformes \u00e0 l\u2019ICH<\/li>\n<li>D\u00e9veloppement et validation des fiches ma\u00eetresses de m\u00e9dicaments (FMM)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe56ea9 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"fe56ea9\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-01307ef elementor-widget elementor-widget-heading\" data-id=\"01307ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Domaines d\u2019expertise particuliers<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5057c214 solutions_content_box e-flex e-con-boxed e-con e-child\" data-id=\"5057c214\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-13194068 e-flex e-con-boxed e-con e-child\" data-id=\"13194068\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2f0f46eb padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"2f0f46eb\" 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\t\t<strong style=\"display: block; margin-bottom: 10px;\">Pharmaceutique:<\/strong>\n<ul>\n \t<li>D\u00e9veloppement et fabrication d\u2019API et HPAPI<\/li>\n \t<li>Interm\u00e9diaires avanc\u00e9s<\/li>\n \t<li>Compos\u00e9s puissants \/ cytotoxiques<\/li>\n \t<li>Des toxines de liaison pour soutenir la fabrication d\u2019ADC<\/li>\n \t<li>Chimie des nucl\u00e9osides \u2013 API g\u00e9n\u00e9riques<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-54823cdf e-flex e-con-boxed e-con e-child\" data-id=\"54823cdf\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e85b73a padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"7e85b73a\" 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\t\t<strong style=\"display:block; margin-bottom: 10px;\">Biopharmaceutique :<\/strong>\n<ul>\n \t<li>Chimie des glucides \/ Sucres rares et bloqu\u00e9s<\/li>\n \t<li>Stabilisateurs de prot\u00e9ines \/ Excipients de qualit\u00e9 parent\u00e9rale<\/li>\n \t<li>Composants de bioproc\u00e9d\u00e9s<\/li>\n \t<li>Administration de m\u00e9dicaments \/ Solubilisants<\/li>\n \t<li>Stabilisateurs de vaccins<\/li>\n \t<li>Lyoprotecteurs<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5430070 e-flex e-con-boxed e-con e-parent\" data-id=\"5430070\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-55244a8 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"55244a8\" 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\t\t<strong style=\"display: block; margin-bottom: 10px;\">Points forts du d\u00e9veloppement de processus :<\/strong>\n<ul>\n \t<li>D\u00e9veloppement rapide des proc\u00e9d\u00e9s chimiques et optimisation des itin\u00e9raires, en mettant l\u2019accent sur la s\u00e9curit\u00e9 des processus SafeBridge<\/li>\n \t<li>Exp\u00e9rience et expertise pour surmonter les goulots d\u2019\u00e9tranglement des processus et faciliter l\u2019am\u00e9lioration des processus<\/li>\n \t<li>Le d\u00e9veloppement des proc\u00e9d\u00e9s se concentre sur les rendements, l\u2019\u00e9volutivit\u00e9, la s\u00e9curit\u00e9, l\u2019impact environnemental limit\u00e9 et l\u2019\u00e9conomie<\/li>\n \t<li>Soutien \u00e0 la mise \u00e0 l\u2019\u00e9chelle et \u00e0 la validation des processus<\/li>\n \t<li>D\u00e9veloppement de PME \u00e0 petite \u00e9chelle<\/li>\n \t<li>Synth\u00e8se personnalis\u00e9e non cGMP \u00e0 l\u2019\u00e9chelle du laboratoire<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4381ab5 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"4381ab5\" 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\t\t<strong style=\"display: block; margin-bottom: 10px;\">Les services analytiques comprennent :<\/strong>\n<ul>\n \t<li>D\u00e9veloppement et validation de m\u00e9thodes analytiques :\n<ul style=\"margin: 14px 0;\">\n \t<li style=\"list-style-type: none;\">\n<ul>\n \t<li>D\u00e9veloppement de sp\u00e9cifications de dosage\/lib\u00e9ration pour une lib\u00e9ration multi-officinale rationalis\u00e9e<\/li>\n \t<li>Profilage des impuret\u00e9s<\/li>\n \t<li>Analyse structurelle<\/li>\n \t<li>D\u00e9veloppement et validation de m\u00e9thodes de d\u00e9tection des endotoxines et des glucanes<\/li>\n \t<li>Quantification des impuret\u00e9s \u00e9l\u00e9mentaires \u00e0 de faibles niveaux de ppb<\/li>\n \t<li>Concentration de nitrosamines et impuret\u00e9s N-nitroso-structurales, concentration en nitrite<\/li>\n \t<li>D\u00e9tection et validation de l\u2019ADN\/ARN\/DNase\/RNase<\/li>\n \t<li>Qualification standard de r\u00e9f\u00e9rence<\/li>\n \t<li>D\u00e9veloppement et validation de m\u00e9thodes de nettoyage<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n \t<li>Tests de stabilit\u00e9 ICH et d\u00e9veloppement de protocoles<\/li>\n \t<li>Caract\u00e9risation des marqueurs d\u2019impuret\u00e9s<\/li>\n \t<li>Programme KYPP pour suivre et \u00e9tablir des tendances en mati\u00e8re d\u2019attributs de qualit\u00e9 analytique<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c02fa5 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2c02fa5\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ebbd092 elementor-widget elementor-widget-heading\" data-id=\"ebbd092\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Installations et \u00e9quipements<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f221538 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"f221538\" 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\t\t<p><strong style=\"display: block; margin-bottom: 5px;\">FABRICATION DE KILO LAB<\/strong><\/p>\n<p>Pfanstiehl dispose d\u2019une installation de confinement polyvalente d\u2019un kilo de laboratoire sur place, notamment :<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul style=\"margin-top: 10px;\">\n<li>Isolateur de synth\u00e8se de bo\u00eete \u00e0 gants Carlisle \u2013 Filtre Hastelloy C et s\u00e9chage en plateau confin\u00e9<\/li>\n<li>R\u00e9acteur en verre de 100 litres dans la cabine de fum\u00e9e \u00e0 confinement complet de Howorth<\/li>\n<li>R\u00e9acteur d\u2019hydrog\u00e9nation Hastelloy C de 100 litres (50 psi)<\/li>\n<li>Large plage de temp\u00e9ratures de traitement \u2013 (-)80\u00baC \u00e0 (+)200\u00baC<\/li>\n<li>Certifi\u00e9 pour traiter des compos\u00e9s jusqu\u2019\u00e0 0,10 ug\/m\u00b3 &#8211; Compatible SafeBridge Cat\u00e9gorie 4<\/li>\n<li>Synth\u00e8se personnalis\u00e9e non cGMP \u00e0 l\u2019\u00e9chelle du kilom\u00e8tre<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-995bd08 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"995bd08\" 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\t\t<p><strong style=\"display: block; margin-bottom: 5px;\">FABRICATION \u00c0 L\u2019\u00c9CHELLE PILOTE ET COMMERCIALE<\/strong><\/p>\n<p>Pfanstiehl est \u00e9quip\u00e9 de :<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Fabrication \u00e0 grande \u00e9chelle et \u00e0 haute puissance \u2013 Classe 100 000 \/ SafeBridge Cat\u00e9gorie 1-3<\/li>\n<li>Plusieurs trains de r\u00e9acteurs \u00e9maill\u00e9s de 300 gallons, d\u2019une capacit\u00e9 totale de r\u00e9acteur primaire de 1 500 gallons<\/li>\n<li>L\u2019usine flexible cGMP peut produire jusqu\u2019\u00e0 ~100 kg de lots de m\u00e9dicaments puissants \/ cytotoxiques<\/li>\n<li>Nouveau filtre s\u00e9cheur Hastelloy C Nutsche de 0,4 m\u00b2 avec isolateur de bo\u00eete \u00e0 gants de confinement, ainsi qu\u2019une multitude de filtres Aurora portables (Hastelloy C et Stainless Steel)<\/li>\n<li>Broyage de compos\u00e9s puissants contenus<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1b4d97e8 e-flex e-con-boxed e-con e-parent\" data-id=\"1b4d97e8\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5d407bf8 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"5d407bf8\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5d68019d e-flex e-con-boxed e-con e-parent\" data-id=\"5d68019d\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-727c6535 elementor-widget elementor-widget-text-editor\" data-id=\"727c6535\" 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\t\t<p>En vous associant \u00e0 Pfanstiehl, vous avez acc\u00e8s \u00e0 un partenaire fiable et exp\u00e9riment\u00e9 qui se consacre \u00e0 fournir des solutions de fabrication d\u2019API personnalis\u00e9es de haute qualit\u00e9 dans les d\u00e9lais et le budget impartis.<\/p>\n<\/p>\n<p>Questionne? Cliquez sur le bouton Contactez-nous ci-dessous et l\u2019un de nos scientifiques du support technique se fera un plaisir de vous aider.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57bc7f5 elementor-widget elementor-widget-button\" data-id=\"57bc7f5\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contactez-nous<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1151a65f e-con-full right_fixed_btn e-flex e-con e-parent\" data-id=\"1151a65f\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-62638fb6 fixed_desktop_btn elementor-widget elementor-widget-button\" data-id=\"62638fb6\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contactez-nous<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b6b0841 fixed_mobile_btn elementor-widget elementor-widget-button\" data-id=\"5b6b0841\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":0,"menu_order":0,"template":"elementor_header_footer","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false},"class_list":["post-4956","solutions","type-solutions","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Fabrication d\u2019API personnalis\u00e9es - Pfanstiehl<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pfanstiehl.com\/fr\/solutions\/fabrication-dapi-personnalisees\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fabrication d\u2019API personnalis\u00e9es - Pfanstiehl\" \/>\n<meta property=\"og:description\" content=\"Services de fabrication d\u2019ingr\u00e9dients pharmaceutiques actifs personnalis\u00e9s de Pfanstiehl Avec une longue exp\u00e9rience r\u00e9ussie dans la fabrication d\u2019ingr\u00e9dients pharmaceutiques actifs (API) personnalis\u00e9s, Pfanstiehl s\u2019est impos\u00e9 comme un partenaire de confiance engag\u00e9 \u00e0 fournir des solutions adapt\u00e9es aux besoins uniques de nos clients. 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