{"id":424,"date":"2018-03-03T18:35:47","date_gmt":"2018-03-03T18:35:47","guid":{"rendered":"https:\/\/purna.be\/development\/"},"modified":"2021-11-18T12:47:55","modified_gmt":"2021-11-18T11:47:55","slug":"development","status":"publish","type":"page","link":"https:\/\/www.purna.be\/nl\/development\/","title":{"rendered":"Development"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; background_color=&#8221;rgba(0,0,0,0)&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_start=&#8221;rgba(184,215,220,0)&#8221; background_color_gradient_end=&#8221;#b8d7dc&#8221; background_color_gradient_overlays_image=&#8221;on&#8221; background_image=&#8221;https:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/purna-2-3.jpg&#8221; background_position=&#8221;top_center&#8221; custom_padding=&#8221;54px|0px|30px|0px&#8221;][et_pb_row _builder_version=&#8221;3.25&#8243; background_color=&#8221;#ffffff&#8221; max_width=&#8221;800px&#8221; custom_padding=&#8221;0px|0px|0px|0px&#8221; use_custom_width=&#8221;on&#8221; custom_width_px=&#8221;800px&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;SCOPE&#8221; module_id=&#8221;scope&#8221; _builder_version=&#8221;3.27.4&#8243; custom_margin=&#8221;25px|25px|25px|25px&#8221;]<\/p>\n<h2>DOMEIN<\/h2>\n<p>Een totaaloplossing van API tot afgewerkt product. Met onze zeer specifieke expertise kunnen we uw product begeleiden van vroege ontwikkeling tot en met commerci\u00eble productie. We bieden deze service aan voor zowel kleine veelbelovende start-ups of spin-off&#8217;s, als voor grote multinationale klanten. In een aangepaste omgeving en met kennis van GMP &amp; FDA (QbD \/ DoE) worden projecten afgehandeld en waar nodig wordt de volledige ondersteuning bij registratie geboden.<br \/>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_divider show_divider=&#8221;off&#8221; _builder_version=&#8221;3.2&#8243; background_color=&#8221;rgba(0,0,0,0)&#8221;]&nbsp;<br \/>\n[\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; background_color=&#8221;#ffffff&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;0px|0px|0px|0px&#8221; column_structure=&#8221;2_3,1_3&#8243;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;SERVICES&#8221; module_id=&#8221;services&#8221; _builder_version=&#8221;3.27.4&#8243; custom_margin=&#8221;25px|||25px&#8221;]<\/p>\n<h2>DIENSTEN<\/h2>\n<p>Onze diensten richten zich op farmaceutische producten (humaan en veterinair), medische hulpmiddelen en cosmetica. Tijdens het ontwikkelingsproces is een toegewezen projectmanager uw enige aanspreekpunt. Hij\/zij zorgt dat uw project binnen de geplande tijd en budget wordt gerealiseerd. Met ontwikkeling en productie onder hetzelfde dak, is er geen technische of analytische transfer nodig om te komen tot commerci\u00eble productie.<br \/>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/Development_Services.png&#8221; show_bottom_space=&#8221;off&#8221; _builder_version=&#8221;3.23&#8243; max_width_last_edited=&#8221;off|desktop&#8221; always_center_on_mobile=&#8221;off&#8221;]&nbsp;<br \/>\n[\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_divider show_divider=&#8221;off&#8221; _builder_version=&#8221;3.2&#8243; background_color=&#8221;rgba(0,0,0,0)&#8221;]&nbsp;<br \/>\n[\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; background_color=&#8221;#ffffff&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;0px|0px|0px|0px&#8221; column_structure=&#8221;2_3,1_3&#8243;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;ANALYTICAL DEVELOPMENT&#8221; module_id=&#8221;analyticaldevelopment&#8221; _builder_version=&#8221;3.27.4&#8243; custom_margin=&#8221;25px|25px|25px|25px&#8221;]<\/p>\n<h2>ANALYTISCHE ONTWIKKELING<\/h2>\n<p>Purna heeft een volledig GLP-conform analytisch laboratorium met een toegewijd, ervaren R&amp;D-team dat volgende diensten biedt:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>API-kwalificatie (compendiale testen, sproeidrogen, viscometrie, residuele oplosmiddelen, densitometrie, polymorfisme)<\/li>\n<li>Methodeontwikkeling (UHPLC, HPLC, GC) voor gehaltebepalingen en stabiliteits-indicatievemethoden<\/li>\n<li>Methode-optimalisatie, validatie en transfer<\/li>\n<li>Degradatie- en stabiliteitsstudies<\/li>\n<li>Microbiologische evaluatie<\/li>\n<li>Dissolutietesten<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/i_purna-cd1.jpg&#8221; align_tablet=&#8221;center&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;3.23&#8243;]&nbsp;<br \/>\n[\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; background_color=&#8221;rgba(0,0,0,0)&#8221; custom_padding=&#8221;0px|0px|54px|0px&#8221;][et_pb_row _builder_version=&#8221;3.25&#8243; background_color=&#8221;rgba(255,255,255,0)&#8221; max_width=&#8221;800px&#8221; custom_margin=&#8221;|||&#8221; use_custom_width=&#8221;on&#8221; custom_width_px=&#8221;800px&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||18px&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;FORMULATION DEVELOPMENT&#8221; module_id=&#8221;formulationdevelopment&#8221; _builder_version=&#8221;3.27.4&#8243;]<\/p>\n<h1>FORMULERING ONTWIKKELING<\/h1>\n<p class=\"lead\">Wij bieden meer dan 30 jaar ervaring in de formulatie van oplossingen, suspensies, emulsies, lotions, cr\u00e8mes, gels, zalven, pasta&#8217;s, poeders en licht ontvlambare producten. Wij kunnen u helpen met:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Herformulatie of creatie van innovatieve lijnextensies<\/li>\n<li>De-novo formulatie<\/li>\n<li>Generische ontwikkeling<\/li>\n<li>Formulatie van API&#8217;s met complexe fysieke of chemische kenmerken<\/li>\n<li>Ontwikkeling van reinigingsmethodes<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"lead\">Purna onderscheidt zich als een flexibele, betrouwbare en transparante partner die u helpt bij het vinden van op maat gemaakte oplossingen.<\/p>\n<p>Tijdens de ontwikkeling houden we altijd het grotere plaatje in het achterhoofd en beperken we het risico op falen in een later stadium.<\/p>\n<p>Door producten voor de VS te ontwikkelen, kunnen we de QbD (Quality by Design) \/ DoE (Design of Experiments) -benadering volgen bij de ontwikkeling en productie van formulaties.<br \/>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/Development_Banner.png&#8221; align_tablet=&#8221;center&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;3.23&#8243;]&nbsp;<br \/>\n[\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; background_color=&#8221;rgba(255,255,255,0)&#8221; max_width=&#8221;800px&#8221; custom_margin=&#8221;|||&#8221; use_custom_width=&#8221;on&#8221; custom_width_px=&#8221;800px&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||18px&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;IMP CLINICAL PHASE&#8221; module_id=&#8221;impclinicalphase&#8221; _builder_version=&#8221;3.27.4&#8243;]<\/p>\n<h2>IMP KLINISCHE FASE<\/h2>\n<p>Purna heeft een IMP-licentie voor de productie, verpakking, etikettering,\u00a0<a name=\"upscaling\"><\/a>analyse en vrijgave van klinisch onderzoeksmateriaal en biedt hieronder kleinschalige producties aan voor preklinische studies en cGMP-klinisch materiaal (Fasen I-III)<br \/>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; background_color=&#8221;#ffffff&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;0px|0px|0px|0px&#8221; column_structure=&#8221;2_3,1_3&#8243;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;UPSCALING&#8221; module_id=&#8221;upscaling&#8221; _builder_version=&#8221;3.27.4&#8243; custom_margin=&#8221;25px|25px|25px|25px&#8221;]<\/p>\n<h2>UPSCALING<\/h2>\n<p>Met een team van hoog opgeleide en ervaren ingenieurs, operatoren en technici bieden we een productieprogramma aan dat een naadloze overgang van laboschaal naar productie op industri\u00eble schaal mogelijk maakt, inclusief ontwikkeling van verpakkingsprocessen (primair en secundair), ordervoorbereiding, de volledige proces-, holding -, verpakkings- en reinigingsvalidatie.<\/p>\n<p>Halfvaste bereidingen (cr\u00e8mes, zalven, pasta&#8217;s en gels) kunnen opgeschaald worden van labo naar industri\u00eble omgeving, gaande van 2L, 20L tot 700L en 2000L. De verschillende productietanken zijn uitgerust met dezelfde technologie wat het up-scalen vergemakkelijkt.<\/p>\n<p>Vloeistoffen kunnen opgeschaald worden van labo tot industri\u00eble omgeving, gaande van 150L tot 1000L, 5000L en 10.000L.<br \/>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/i_tank.jpg&#8221; align_tablet=&#8221;center&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;3.23&#8243;]&nbsp;<br \/>\n[\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; background_color=&#8221;#ffffff&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;27px|0px|0px|0px&#8221; column_structure=&#8221;2_3,1_3&#8243;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;ICH STABILITY STUDIES&#8221; module_id=&#8221;ichstabilitystudies&#8221; _builder_version=&#8221;3.27.4&#8243; custom_margin=&#8221;25px|25px|25px|25px&#8221;]<\/p>\n<h2>ICH STABILITEITSSTUDIES<\/h2>\n<p>Purna biedt stabiliteitsopslag aan onder alle ICH-klimaatzones ter ondersteuning van langetermijn, tussentijdse, versnelde, fotosensibiliteit, transport, in-use en continu\u00eb (FUST) stabiliteitsstudies.<\/p>\n<h2>API&#8217;S<\/h2>\n<p>Algemene API&#8217;s, evenals corticostero\u00efden, zeer krachtige, cytotoxische en gecontroleerde geneesmiddelen worden binnen Purna behandeld.<br \/>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/i_stability.jpg&#8221; align_tablet=&#8221;center&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;3.23&#8243;]&nbsp;<br \/>\n[\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; background_color=&#8221;rgba(0,0,0,0)&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_start=&#8221;rgba(184,215,220,0)&#8221; background_color_gradient_end=&#8221;#b8d7dc&#8221; background_color_gradient_overlays_image=&#8221;on&#8221; background_image=&#8221;https:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/purna-2-3.jpg&#8221; background_position=&#8221;top_center&#8221; custom_padding=&#8221;54px|0px|30px|0px&#8221;][et_pb_row _builder_version=&#8221;3.25&#8243; background_color=&#8221;#ffffff&#8221; max_width=&#8221;800px&#8221; custom_padding=&#8221;0px|0px|0px|0px&#8221; use_custom_width=&#8221;on&#8221; custom_width_px=&#8221;800px&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;SCOPE&#8221; module_id=&#8221;scope&#8221; _builder_version=&#8221;3.27.4&#8243; custom_margin=&#8221;25px|25px|25px|25px&#8221;] DOMEIN Een totaaloplossing van API tot afgewerkt product. Met onze zeer specifieke expertise kunnen we uw product begeleiden van vroege ontwikkeling tot en met commerci\u00eble productie. We bieden deze service [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-424","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.9 - aioseo.com -->\n\t<meta name=\"description\" content=\"[et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d3.22\u2033 background_color=\u201drgba(0,0,0,0)\u201d use_background_color_gradient=\u201don\u201d background_color_gradient_start=\u201drgba(184,215,220,0)\u201d background_color_gradient_end=\u201d#b8d7dc\u201d background_color_gradient_overlays_image=\u201don\u201d background_image=\u201dhttps:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/purna-2-3.jpg\u201d background_position=\u201dtop_center\u201d custom_padding=\u201d54px|0px|30px|0px\u201d][et_pb_row _builder_version=\u201d3.25\u2033 background_color=\u201d#ffffff\u201d max_width=\u201d800px\u201d custom_padding=\u201d0px|0px|0px|0px\u201d use_custom_width=\u201don\u201d custom_width_px=\u201d800px\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d3.25\u2033 custom_padding=\u201d|||\u201d custom_padding__hover=\u201d|||\u201d][et_pb_text admin_label=\u201dSCOPE\u201d module_id=\u201dscope\u201d _builder_version=\u201d3.27.4\u2033 custom_margin=\u201d25px|25px|25px|25px\u201d]DOMEIN Een totaaloplossing van API tot afgewerkt product. Met onze zeer specifieke expertise kunnen we uw product begeleiden van vroege ontwikkeling tot en met commerci\u00eble productie. We bieden deze service aan\" \/>\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<link rel=\"canonical\" href=\"https:\/\/www.purna.be\/nl\/development\/\" \/>\n\t<meta name=\"generator\" content=\"All in One SEO (AIOSEO) 4.9.9\" \/>\n\t\t<meta property=\"og:locale\" content=\"nl_NL\" \/>\n\t\t<meta property=\"og:site_name\" content=\"Purna Pharmaceuticals - Quality is never an accident\" \/>\n\t\t<meta property=\"og:type\" content=\"article\" \/>\n\t\t<meta property=\"og:title\" content=\"Development - Purna Pharmaceuticals Development\" \/>\n\t\t<meta property=\"og:description\" content=\"[et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d3.22\u2033 background_color=\u201drgba(0,0,0,0)\u201d use_background_color_gradient=\u201don\u201d background_color_gradient_start=\u201drgba(184,215,220,0)\u201d background_color_gradient_end=\u201d#b8d7dc\u201d background_color_gradient_overlays_image=\u201don\u201d background_image=\u201dhttps:\/\/www.purna.be\/wp-content\/uploads\/2018\/02\/purna-2-3.jpg\u201d background_position=\u201dtop_center\u201d custom_padding=\u201d54px|0px|30px|0px\u201d][et_pb_row _builder_version=\u201d3.25\u2033 background_color=\u201d#ffffff\u201d max_width=\u201d800px\u201d custom_padding=\u201d0px|0px|0px|0px\u201d use_custom_width=\u201don\u201d custom_width_px=\u201d800px\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d3.25\u2033 custom_padding=\u201d|||\u201d custom_padding__hover=\u201d|||\u201d][et_pb_text admin_label=\u201dSCOPE\u201d module_id=\u201dscope\u201d _builder_version=\u201d3.27.4\u2033 custom_margin=\u201d25px|25px|25px|25px\u201d]DOMEIN Een totaaloplossing van API tot afgewerkt product. 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