{"id":5169,"date":"2023-06-04T15:53:11","date_gmt":"2023-06-04T13:53:11","guid":{"rendered":"https:\/\/www.abiogen.it\/manufacturing\/"},"modified":"2025-07-28T11:50:30","modified_gmt":"2025-07-28T09:50:30","slug":"manufacturing","status":"publish","type":"page","link":"https:\/\/www.abiogen.it\/en\/manufacturing\/","title":{"rendered":"Manufacturing"},"content":{"rendered":"<p><section data-bb-version=\"4.5.6\" id=\"bt_bb_section69da1176c0bfd\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row bt_bb_row_push_left bt_bb_content_wide bt_bb_row_width_boxed_1200 bt_bb_row_width_boxed  bt_bb_animation_fade_in move_right animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div data-bb-version=\"4.6.1\"  class=\"bt_bb_column col-xxl-6 col-xl-6 col-with-bkg bt_bb_vertical_align_top bt_bb_align_left bt_bb_column_background_image bt_bb_padding_normal bt_bb_details_right-inner bt_bb_details-color_white\" style=\"position: relative;background-image:url(&#039;https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/07\/manufacturing-min-1.jpg&#039;);; --column-width:6;\" data-width=\"6\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><\/div><\/div><\/div><div  class=\"bt_bb_column col-xxl-6 col-xl-6 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:6;\" data-width=\"6\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" ><\/p>\n<p>Since the creation of Abiogen Pharma, the strategic choice has been to enhance and develop the know how gained through years of manufacturing and the skills acquired in pharmaceutical development.<br \/>\nThe Abiogen Manufacturing aim is to manage both the manufacturing and development of the projects and products of Abiogen Pharma, and the development of manufacturing for external clients.<\/p>\n<p>In fact, Abiogen Pharma performs CMO and CDMO activities, supporting pharmaceutical companies as a strategic partner throughout the entire lifecycle of a drug, offering services such as: development of a drug&#8217;s formulation and technical Dossier, analytical testing, scale-up, and commercial production.<\/p>\n<p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section data-bb-version=\"4.5.6\" id=\"bt_bb_section69da1176c199d\" class=\"bt_bb_section bt_bb_layout_boxed_1200 bt_bb_vertical_align_top bt_bb_top_spacing_large bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_large&quot;,&quot;def&quot;:&quot;large&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div data-bb-version=\"4.5.6\"  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_top bt_bb_align_left bt_bb_padding_normal\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><header data-bb-version=\"4.6.1\" class=\"bt_bb_headline bt_bb_subheadline_text_transform_default bt_bb_dash_none bt_bb_size_normal bt_bb_align_inherit\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><h2 class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Quality assurance<\/span><\/span><\/h2><\/header><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_normal\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><\/div><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" ><\/p>\n<p>Compliance to the GCP for clinical studies and the GMP for production, is constantly monitored by periodic internal inspections to the studies and the production processes. Maintenance, upgrading and continuous growth of know how is made possible by regular customer audits, representing a rare opportunity for analysis and comparison with the greatest representatives of the quality and manufacturing sector. The results of these audits through the respective services of Quality Assurance are further evidence that Abiogen Pharma\u2019s Pharmaceutical Factory offers an adequate and consistent sphere of quality assurance.<\/p>\n<p>\n<\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_medium\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;}}\"><\/div><header data-bb-version=\"4.6.1\" class=\"bt_bb_headline bt_bb_subheadline_text_transform_default bt_bb_dash_none bt_bb_size_normal bt_bb_align_inherit\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><h3 class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Main chemical analysis and physical-chemical techniques<\/span><\/span><\/h3><\/header><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_normal\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_accordion bt_bb_color_scheme_4 bt_bb_style_outline bt_bb_shape_square\" style=\"; --accordion-primary-color:#d71920; --accordion-secondary-color:#ffffff;\" data-closed=closed><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Chemical and physical chemical analysis<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Tin Layer Chromatography<\/li>\n<li>High Performance Liquid Chromatography (HPLC)<\/li>\n<li>Ionic Chromatography<\/li>\n<li>Gas-Chromatography<\/li>\n<li>Gas-Chromatography Head Space Tecnic<\/li>\n<li>UV-VIS Spectroscopy<\/li>\n<li>Infrared Spectroscopy (FTIR)<\/li>\n<li>Atomic Absorpion Spectrometry<\/li>\n<li>NIR Spectroscopy<\/li>\n<li>TOC Determination<\/li>\n<li>Visible and Subvisible Particolate Contamination<\/li>\n<li>Acid-base titrations<\/li>\n<li>Complexometric titrations<\/li>\n<li>Redox titrations<\/li>\n<li>Potentiometry<\/li>\n<li>Conductometry<\/li>\n<li>Polarimetry &amp; Optical Rotation<\/li>\n<li>Microwave Mineralization<\/li>\n<li>Steam Distillation<\/li>\n<li>Physical Characterization (melting point, refractive index, density, viscosity)<\/li>\n<li>Detector Massa<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Biologic and microbiologic controls<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Sterility test<\/li>\n<li>Bioburden<\/li>\n<li>LAL test<\/li>\n<li>Like Heparin activity determination<\/li>\n<li>Biological assay of actives<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Technical-pharmaceutical controls<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Loss on drying<\/li>\n<li>Disaggregation<\/li>\n<li>Dissolution<\/li>\n<li>Friability<\/li>\n<li>Tablets Hardness, Thickness, Diameter<\/li>\n<li>Disaggregation time of suppository<\/li>\n<li>Hardness of Ampoules<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Process Validation<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Process Validation<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Technology transfer and validation<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Technology Transfer from Development to Pilot Production<\/li>\n<li>Technology Transfer of commercial products Demonstration lots<\/li>\n<li>Analytical Transfers<\/li>\n<li>Process Validation<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_medium\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;}}\"><\/div><header data-bb-version=\"4.6.1\" class=\"bt_bb_headline bt_bb_subheadline_text_transform_default bt_bb_dash_none bt_bb_size_normal bt_bb_align_inherit\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><h3 class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Quality assurance<\/span><\/span><\/h3><\/header><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_normal\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_accordion bt_bb_color_scheme_4 bt_bb_style_outline bt_bb_shape_square\" style=\"; --accordion-primary-color:#d71920; --accordion-secondary-color:#ffffff;\" data-closed=closed><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Main activities<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Product release<\/li>\n<li>Process validation<\/li>\n<li>Cleaning validation<\/li>\n<li>Deviations &amp; CAPA<\/li>\n<li>Compliants &amp; Recall<\/li>\n<li>Environmental &amp; utilities monitoring<\/li>\n<li>Supplier audits<\/li>\n<li>Self Inspection<\/li>\n<li>Documentation control<\/li>\n<li>Analytical tranfer<\/li>\n<li>On-going stability studies<\/li>\n<li>Chemical analysis<\/li>\n<li>Microbiology analysis<\/li>\n<li>Sterility testing<\/li>\n<li>Computer systems validation<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section data-bb-version=\"4.6.1\" id=\"bt_bb_section69da1176c2b22\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_row bt_bb_row_push_right bt_bb_content_wide bt_bb_row_width_boxed_1200 bt_bb_row_width_boxed  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div data-bb-version=\"4.5.6\"  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_20&quot;,&quot;def&quot;:&quot;20&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><header data-bb-version=\"4.6.1\" class=\"bt_bb_headline bt_bb_subheadline_text_transform_default bt_bb_dash_none bt_bb_size_normal bt_bb_align_inherit\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><h2 class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Integrated pharmaceutical development services<\/span><\/span><\/h2><\/header><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_normal\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><\/div><\/div><\/div><\/div><\/div><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_row bt_bb_row_push_right bt_bb_content_wide bt_bb_row_width_boxed_1200 bt_bb_row_width_boxed  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xxl-6 col-xl-6 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:6;\" data-width=\"6\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" ><\/p>\n<p>The knowledge and expertise acquired over many years of activity supporting research in the development of products from Abiogen\u2019s product list, makes Pharmaceutical Development one of the strengths of the Business Manufacturing area.<br \/>\nThe department consists of an area equipped for production and a quality control unit for Investigation Medicinal Products (IMPs) which operate according to the EU-GMP Good Manufacturing Practices Annex 13.<br \/>\nThe production unit has an area for the production of IMPs for clinical phases III-IV (pilot scale).<\/p>\n<p>\n<\/div><\/div><\/div><\/div><div data-bb-version=\"4.6.1\"  class=\"bt_bb_column col-xxl-6 col-xl-6 bt_bb_vertical_align_top bt_bb_align_left bt_bb_column_background_image bt_bb_padding_normal bt_bb_details_left-inner bt_bb_details-color_white\" style=\"position: relative;background-image:url(&#039;https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/09\/servizi-integrati-min.jpg&#039;);; --column-width:6;\" data-width=\"6\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section data-bb-version=\"4.5.6\" id=\"bt_bb_section69da1176c3aaa\" class=\"bt_bb_section bt_bb_layout_boxed_1200 bt_bb_vertical_align_top bt_bb_top_spacing_large bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_large&quot;,&quot;def&quot;:&quot;large&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div data-bb-version=\"4.5.6\"  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_top bt_bb_align_left bt_bb_padding_normal\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_accordion bt_bb_color_scheme_4 bt_bb_style_outline bt_bb_shape_square\" style=\"; --accordion-primary-color:#d71920; --accordion-secondary-color:#ffffff;\" data-closed=closed><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">The GMP-approved facilities cover an area of 1500 m2 divided into:<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<p>Analytical laboratories, well equipped with the latest state-of-art machinery, assure the timely release of IMPs. The areas have been GMP accredited for Good Manufacturing Practices EU-GMP annex 13 since 2005.<\/p>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Management of preformulation activities<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Drug substance characterisation<\/li>\n<li>Investigation on solid state properties of API<\/li>\n<li>pH \/ solubility profiles<\/li>\n<li>Forced degradation studies<\/li>\n<li>Excipient compatibility studies<\/li>\n<li>Compatibility Studies between API and container<\/li>\n<li>Blend characterization<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Management of formulation development activities<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Formulation Development for early studies<\/li>\n<li>Prototype formulations for clinical trials<\/li>\n<li>Product Reformulation for Innovation &amp; Product Life Cycle management<\/li>\n<li>Preliminary process identification<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Process optimization &amp; scale-up<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Manufacture of pivotal stability batches<\/li>\n<li>Process scale-up (from lab. to pilot scale and from pilot to industrial scale)<\/li>\n<li>Process optimization for commercial scale manufacture<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Clinical manufacturing<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Manufacturing and release testing of phase III and IV drug product<\/li>\n<li>Dedicated secondary packaging operations areas<\/li>\n<li>Dedicated storage area for raw materials and finished IMPs<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Technology transfer &amp; validation<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Tech Transfer from development R&amp;D to pilot plant<\/li>\n<li>Tech Site Transfer of commercial products<\/li>\n<li>Demonstration batches<\/li>\n<li>Analytical Transfer<\/li>\n<li>Process Validation<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Analytical support, development &amp; validation<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Development and Validation of analytical methods<\/li>\n<li>Dissolution and drug-release profiling<\/li>\n<li>Specifications development<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Stability studies<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Stress testing<\/li>\n<li>Photostability testing (according to ICH)<\/li>\n<li>Formal stability (all storage condition according to ICH)<\/li>\n<li>On-going stability<\/li>\n<li>In-use stability<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Regulatory support<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>MPD (Investigational Medicinal Product Dossier)<\/li>\n<li>PSF (Product Specification File, GMP Annex 13)<\/li>\n<li>CTD Quality (Common Technical Document module 3.2 \/ module 3) for Product Registration<\/li>\n<li>Type IA, Type IB and Type II Variations (CE 1234\/2008 regulation)<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Formulation &amp; process technology<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Small volume parenterals (ampoules, aseptic and terminally sterilized process)<\/li>\n<li>Blending and Granulation (High shear granulator \/ drier, Top spray fluid bed granulation, Fluid bed driers)<\/li>\n<li>Compression (single punch and high-speed rotary tablet presses)<\/li>\n<li>Tablet-coating (film and sugar coats)<\/li>\n<li>Capsule filling (Coni-snap\u00ae Vcaps\u2122, DBcaps\u00ae)<\/li>\n<li>Liquid and Semi-solid (solution, suspensions, emulsion, creams, gels, lotions and ointments)<\/li>\n<li>Comparator-blinding services, including encapsulation and coating<\/li>\n<li>Placebo development for use in blinded studies<\/li>\n<li>Primary packaging in blisters, bottles and tubes<\/li>\n<li>Secondary packaging for open-label or double-blind studies<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Analytical technology<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<ul>\n<li>Liquid Chromatography: HPLC system (UV, diode array, refractive index and MS detectors), HPLC-IC system, UPLC system (UV, diode array)<\/li>\n<li>Gas-Chromatography (GC &amp; HS-GC)<\/li>\n<li>Thin-layer Chromatography (TLC)<\/li>\n<li>Absorption spectrophotometry, infrared (FT-IR)<\/li>\n<li>Absorption spectrophotometry, ultraviolet and visible (UV-VIS)<\/li>\n<li>Dissolution (automatic system)<\/li>\n<li>Disintegration test (with automatic systems)<\/li>\n<li>Potentiometric titration<\/li>\n<li>Osmolality<\/li>\n<li>Optical rotation<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section data-bb-version=\"4.5.6\" id=\"bt_bb_section69da1176c4ec2\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_large bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_large&quot;,&quot;def&quot;:&quot;large&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_row bt_bb_row_push_right bt_bb_content_wide bt_bb_row_width_boxed_1200 bt_bb_row_width_boxed  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div data-bb-version=\"4.5.6\"  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_20&quot;,&quot;def&quot;:&quot;20&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><header data-bb-version=\"4.6.1\" class=\"bt_bb_headline bt_bb_subheadline_text_transform_default bt_bb_dash_none bt_bb_size_normal bt_bb_align_inherit\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><h2 class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Contract development and manufacturing <\/span><\/span><\/h2><\/header><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_normal\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><\/div><\/div><\/div><\/div><\/div><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_row bt_bb_row_push_right bt_bb_content_wide bt_bb_row_width_boxed_1200 bt_bb_row_width_boxed  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xxl-6 col-xl-6 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:6;\" data-width=\"6\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" ><\/p>\n<p>The activities developed and the successes obtained in the last decade confirm the vision of Abiogen Pharma towards a range of services aimed at creating a real value to the projects undertaken and building a synergistic partnership with its customers.<br \/>\nThe offer is developed through the provision of high-quality standards, significant and certified technical-scientific competence and the technological capacity available in the various strategic areas of Manufacturing, Pharmaceutical Development, Purchasing, Quality Unit, Legal Affairs, Logistic and Customer Care and a network of suppliers specialized in quality.<br \/>\nThe projects are evaluated in their complexity and carefully analyzed according to the state of the art regulatory requirements and the value is sought for each project phase by ensuring competitive prices aligned to the European market.<br \/>\nContract Manufacturing, Pharmaceutical Development services and Clinical Supply are the sectors of excellence of Abiogen Pharma\u2019s service contracts.<\/p>\n<p>\n<\/div><\/div><\/div><\/div><div data-bb-version=\"4.6.1\"  class=\"bt_bb_column col-xxl-6 col-xl-6 col-with-bkg bt_bb_vertical_align_top bt_bb_align_left bt_bb_column_background_image bt_bb_padding_normal bt_bb_details_left-inner bt_bb_details-color_white\" style=\"position: relative;background-image:url(&#039;https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/07\/contract-development.jpg&#039;);; --column-width:6;\" data-width=\"6\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section data-bb-version=\"4.5.6\" id=\"bt_bb_section69da1176c5bdd\" class=\"bt_bb_section bt_bb_layout_boxed_1100 bt_bb_vertical_align_top bt_bb_top_spacing_large bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_large&quot;,&quot;def&quot;:&quot;large&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_row  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div data-bb-version=\"4.5.6\"  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_20&quot;,&quot;def&quot;:&quot;20&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><header data-bb-version=\"4.6.1\" class=\"bt_bb_headline bt_bb_subheadline_text_transform_default bt_bb_dash_none bt_bb_size_normal bt_bb_align_inherit\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><h2 class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Plant<\/span><\/span><\/h2><\/header><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_normal\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><\/div><\/div><\/div><\/div><\/div><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_row  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.7.6\" class=\"bt_bb_image bt_bb_shape_square bt_bb_target_self bt_bb_align_inherit bt_bb_hover_style_simple bt_bb_content_display_always bt_bb_content_align_middle\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><span><img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"800\" src=\"https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/11\/plant.jpg\" class=\"attachment-full size-full\" alt=\"https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/11\/plant.jpg\" data-full_image_src=\"https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/11\/plant.jpg\" title=\"plant\" srcset=\"https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/11\/plant.jpg 1200w, https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/11\/plant-640x427.jpg 640w, https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/11\/plant-768x512.jpg 768w, https:\/\/www.abiogen.it\/wp-content\/uploads\/2023\/11\/plant-320x213.jpg 320w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_row  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.6.1\"  class=\"bt_bb_text\" ><\/p>\n<p>The site located on the outskirts of Pisa in Ospedaletto is spread along an area of 120.000 m2 and a covered area of 26.000 m2.<br \/>\nThe premises were designed to align Abiogen Pharma Manufacturing to the state of the art in European pharmaceutical production and pharmaceutical development.<br \/>\nThe flows of materials and personnel meet the strict requirements of the G.M.P (Good Manufacturing Practices) in Europe.<br \/>\nThe layout of the site is considered to be at today\u2019s cutting edge of new pharmaceutical plant construction. It was designed according to the concept of dedicated units per single formulation, each equipped with one or more independent HVAC systems and dedicated entrances for the personnel and materials, respecting the most stringent requirements set by the European GMP (Good Manufacturing Practice).<br \/>\nTwo artificial lakes, built to avoid the use of tap water, secure the cooling of the industrial plants and irrigation of the green areas. Extreme attention was paid to structure rationalization with particular care of the production flows.<br \/>\nThe entire production activity is continuously monitored through an Emerson computerized system that can detect, and, if necessary, restore in real-time all key parameters of the production equipment through digital sensors and optic transmissions.<\/p>\n<p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_row  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.6.1\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;}}\"><\/div><header data-bb-version=\"4.6.1\" class=\"bt_bb_headline bt_bb_subheadline_text_transform_default bt_bb_dash_none bt_bb_size_normal bt_bb_align_inherit\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><h3 class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Industrial areas of the manufacturing division<\/span><\/span><\/h3><\/header><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_normal\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><\/div><div class=\"bt_bb_raw_content\"><table class=\"uk-table uk-table-striped\">\n    <tbody>\n        <tr>\n            <td><strong><strong>Total plant surface<\/strong><\/strong><\/td>\n            <td>120.000 mq.<\/td>\n        <\/tr>\n        <tr>\n            <td><strong><strong>Roofed surface<\/strong><\/strong><\/td>\n            <td>26.000 mq.<\/td>\n        <\/tr>\n        <tr>\n            <td><strong><strong>Raw materials warehouse<\/strong><\/strong><\/td>\n            <td>3.400 mq.<\/td>\n        <\/tr>\n        <tr>\n            <td><strong><strong>Finished product warehouse<\/strong><\/strong><\/td>\n            <td>3.000 mq.<\/td>\n        <\/tr>\n        <tr>\n            <td><strong><strong>Pharmaceutical manufacturing<\/strong><\/strong><\/td>\n            <td>10.000 mq.<\/td>\n        <\/tr>\n        <tr>\n            <td><strong><strong>Pharmaceutical development<\/strong><\/strong><\/td>\n            <td>1.080 mq.<\/td>\n        <\/tr>\n        <tr>\n            <td><strong><strong>Quality control laboratories<\/strong><\/strong><\/td>\n            <td>1.080 mq.<\/td>\n        <\/tr>\n        <tr>\n            <td><strong><strong>Services and Utilities<\/strong><\/strong><\/td>\n            <td>2.000 mq.<\/td>\n        <\/tr>\n        <tr>\n            <td><strong><strong>Offices<\/strong><\/strong><\/td>\n            <td>5.400 mq.<\/td>\n        <\/tr>\n    <\/tbody>\n<\/table><\/div><\/div><\/div><\/div><\/div><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_row  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_accordion bt_bb_color_scheme_4 bt_bb_style_outline bt_bb_shape_square\" style=\"; --accordion-primary-color:#d71920; --accordion-secondary-color:#ffffff;\" data-closed=closed><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Orals Solids<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<p>This production area covers a surface of about 1.800 mq.<\/p>\n<p><strong><span class=\"red-txt\">Production capacities:<\/span><\/strong><br \/>\n350\/400 tons\/ year.<\/p>\n<p><strong><span class=\"red-txt\">Orals solids process:<\/span><\/strong><\/p>\n<ul>\n<li>High shear granulation followed by: static drying or fluid bed drying<\/li>\n<li>Fluid bed granulation<\/li>\n<li>Traditional mixing<\/li>\n<li>Direct mixing<\/li>\n<li>Tableting<\/li>\n<li>Film coating<\/li>\n<li>Hard capsules filling<\/li>\n<\/ul>\n<p><strong><span class=\"red-txt\">Manufacturing equipment:<\/span><\/strong><\/p>\n<ul>\n<li>Fluid-bed processor: Glatt WSG 300 1100 lt<\/li>\n<li>High shear mixer granulator: Gral 300 GEA 300 lt<\/li>\n<li>2 IMA Cyclope Tumbler<\/li>\n<li>High Shear Mixer PMA 1200 GEA Niro Pharma System<\/li>\n<li>Tabletting: Korsch XL 400, Kikosui, Ronchi SA, Ronchi GA<\/li>\n<li>Coating: Film coating machines IMA\/GS ( 2 da 300 lt e 1 da 150 lt)<\/li>\n<li>Hard capsule filling machine: Zanasi 40<\/li>\n<li>IMA Venus Component whashig machine<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Packaging Equipment<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<p><strong class=\"red-txt\">Packaging equipment oral solid<\/strong><\/p>\n<p><strong class=\"red-txt\">Production capacities:<\/strong><br \/>\n30 million\/year pieces<\/p>\n<p><strong class=\"red-txt\">Type of products:<\/strong><\/p>\n<ul>\n<li>Tablets<\/li>\n<li>Hard Capsules<\/li>\n<li>Softgel capsules<\/li>\n<\/ul>\n<p><strong class=\"red-txt\">Packaging equipment:<\/strong><\/p>\n<ul>\n<li>Line Blister 1: Marchesini Integra equipped for serialization\/aggregation and tamper evidence<\/li>\n<li>Line Blister 2: Marchesini Integra equipped for serialization and tamper evidence<\/li>\n<li>Line Blister 3: IMA C90 equipped for serialization and tamper evidence<\/li>\n<li>Line Blister 4: Marchesini Integra equipped for serialization\/aggregation and tamper evidence<\/li>\n<\/ul>\n<p><strong class=\"red-txt\"><br \/>\ntype of blisters:<\/strong><\/p>\n<ul>\n<li>Alu\/alu<\/li>\n<li>PVC\/alu<\/li>\n<li>PVC\/PVDC\/alu<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Injectables<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<p>This production area covers a surface of about 1105 mq.<\/p>\n<p><strong class=\"red-txt\">Production capacities:<\/strong><\/p>\n<ul>\n<li>35 million\/year ampoules (from 1ml to 10ml)<\/li>\n<li>The filling area is run in a class \u201cA\u201d environment.<\/li>\n<\/ul>\n<p><strong class=\"red-txt\">Equipment:<\/strong><\/p>\n<ul>\n<li>BOSCH filling line<\/li>\n<li>FEDEGARI autoclaves<\/li>\n<li>CEA particles inspection machines mod. A35 e mod. A35LD<\/li>\n<li>CMP LT01 Leak Test<\/li>\n<\/ul>\n<p><strong class=\"red-txt\">Packaging:<\/strong><\/p>\n<ul>\n<li>PARTENA NMX and HV CAM\u00a0equipped for serialization\/aggregation and tamper evidence<\/li>\n<\/ul>\n<p><strong class=\"red-txt\">Type of packaging:<\/strong><\/p>\n<ul>\n<li>PVC containers with ALU cover possibility<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Semisolids<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<p>This production area covers a surface of about 200 mq.<\/p>\n<p><strong class=\"red-txt\">Production capacities:<\/strong><\/p>\n<ul>\n<li>8 million\/year semi solid forms: cream, Gel, Ointment, Paste<\/li>\n<\/ul>\n<p><strong class=\"red-txt\"><br \/>\nEquipment:<\/strong><\/p>\n<ul>\n<li>Turbomixer OLSA MACEF PH1000<\/li>\n<\/ul>\n<p><strong class=\"red-txt\">Packaging:<\/strong><\/p>\n<ul>\n<li>aluminium and plastic TUBE FILLING UNIPACK 100 and PMX<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Oral Liquids<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<p>This production area covers a surface of about 800 mq.<\/p>\n<p><strong class=\"red-txt\">Production capacities:<\/strong><br \/>\n45 million\/year oral liquid forms: syrups, drops, lotions<\/p>\n<p><strong class=\"red-txt\">Equipment:<\/strong><\/p>\n<ul>\n<li>2000 and 5000 and 1000 litres stainless steel vessels<\/li>\n<li>N \u00b0 4 Marchesini high-speed influxing lines, 3 of which are suitable for multipacks and all equipped for serialization\/aggregation and tamper evidence<\/li>\n<li>N\u00b01 Comas containers packaging line\u00a0equipped for serialization and tamper evidence<\/li>\n<\/ul>\n<p><strong class=\"red-txt\">Type of containers:<\/strong><\/p>\n<ul>\n<li>Packaging Glass &amp; plastic containers<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Liquid filled capsules<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<p>This production area covers a surface of about 800 mq.<br \/>\n<strong class=\"red-txt\"><br \/>\nProduction capacities:<\/strong><\/p>\n<ul>\n<li>15 million\/year pieces<\/li>\n<\/ul>\n<p><strong class=\"red-txt\">Equipment:<\/strong><\/p>\n<ul>\n<li>Num.2 Filling machine IMA Adapta<\/li>\n<li>Num.2 Sealing machine IMA Hermetica<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Sticks<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text\" >\n<p><strong class=\"red-txt\">Production capacities:<\/strong><br \/>\n800.000\/year pieces<\/p>\n<p><strong class=\"red-txt\">Equipment:<\/strong><\/p>\n<ul>\n<li>4 tracks stick pack machine Omag.<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section data-bb-version=\"4.5.6\" id=\"bt_bb_section69da1176c817e\" class=\"bt_bb_section bt_bb_layout_boxed_1200 bt_bb_vertical_align_top bt_bb_top_spacing_large bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_large&quot;,&quot;def&quot;:&quot;large&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_row bt_bb_row_width_boxed_1200 bt_bb_row_width_boxed  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div data-bb-version=\"4.5.6\"  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_20&quot;,&quot;def&quot;:&quot;20&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><header data-bb-version=\"4.7.6\" class=\"bt_bb_headline bt_bb_subheadline_text_transform_default bt_bb_dash_none bt_bb_size_normal bt_bb_align_inherit\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_normal&quot;,&quot;def&quot;:&quot;normal&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;}}\"><h2 class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Production equipment for clinical studies<\/span><\/span><\/h2><\/header><div data-bb-version=\"4.5.6\" class=\"bt_bb_separator bt_bb_border_style_none bt_bb_border_color_none bt_bb_top_spacing_ bt_bb_bottom_spacing_normal\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_&quot;,&quot;def&quot;:&quot;&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;}}\"><\/div><\/div><\/div><\/div><\/div><\/div><div data-bb-version=\"4.5.6\" class=\"bt_bb_row  bt_bb_animation_fade_in move_left animate\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xxl-12 col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_vertical_align_middle bt_bb_align_left bt_bb_padding_20 bt_bb_animation_fade_in animate bt_bb_details-color_white\" style=\"; --column-width:12;\" data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_column_content_inner\"><div data-bb-version=\"4.5.6\" class=\"bt_bb_accordion bt_bb_color_scheme_4 bt_bb_style_outline bt_bb_shape_square\" style=\"; --accordion-primary-color:#d71920; --accordion-secondary-color:#ffffff;\" data-closed=closed><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Production equipment for clinical studies<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>Twin-Pack Blistering machine O.M.A.R.<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nPVC\/ALU \u2013 PVC-PVDC\/ALU<\/p>\n<p><span class=\"title-grey\">Capability \/ Typical range<\/span><br \/>\n7 cycles\/minute<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>aminar Air Flow (dedicated for API of clinical phase III-IV)<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nSampling and Dispensing<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>Multi Processor MP1 (laboratory fluid bed dryer) GEA Niro Pharma System<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nMixing, Drying, agglomeration, top spray coating<\/p>\n<p><span class=\"title-grey\">Capability \/ Typical range<\/span><br \/>\n6 Kg \u2013 8 Kg (16 litres capacity)<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>PharmaConnect\u00ae (Through-the-Wall) GEA Niro Pharma System<\/strong><\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>Lab Mini Blender Module<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nMixing<\/p>\n<p><span class=\"title-grey\">Capability \/ Typical range<\/span><br \/>\nBin 3 litres 450 g -1,2 Kg &#8211; Bin 5 litres 750 g -2,0 Kg &#8211; Bin 15 litres 2,25 Kg -6 Kg<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>High Shear Mixer<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nGranulation<\/p>\n<p><span class=\"title-grey\">Capability \/ Typical range<\/span><br \/>\nDevelop. scale (3 litres Bowl size) 720 g -1.35 Kg &#8211; Pilot scale (30 litres Bowl size) 7.2 Kg \u2013 13.5 Kg<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>Thermotron T 7510 (Static Essiccator)<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nDrying<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>IMILL-F 5\u2019\u2019 Calibrating mill IMA<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nCalibration of wet or dry products<\/p>\n<p><span class=\"title-grey\">Capability \/ Typical range<\/span><br \/>\nSquare holes (6-8-10 mm) Mainly used for wet granulation Round holes (0.35-6 mm) Mainly used for dry granulation<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>Ronchi EA8 (High-speed rotary tablet presses)<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nTabletting<\/p>\n<p><span class=\"title-grey\">Capability \/ Typical range<\/span><br \/>\n4,800-24,000 tablets\/hour<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>Kramer E80 (De-duster)<\/strong><\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>GS HTM\/25 Tablet-coating equipment<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nTablet coating<\/p>\n<p><span class=\"title-grey\">Capability \/ Typical range<\/span><br \/>\n25 litres<\/p>\n<\/div>\n<div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>Peristaltic pump Watson&amp;Marlow, mod. 520Di<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nLiquid and Semi-solid (creams, gels, lotions and ointments)<\/p>\n<\/div>\n<\/div><\/div><div class=\"bt_bb_accordion_item\"><div class=\"bt_bb_accordion_item_title\"><div class=\"bt_bb_accordion_item_title_content\">Main analytical equipment for clinical studies<\/div><\/div><div class=\"bt_bb_accordion_item_content\"><div data-bb-version=\"4.5.6\"  class=\"bt_bb_text production-equipment-row\" >\n<p><span class=\"title-grey\">Equipment<\/span><br \/>\n<strong>Sotax automatic tester AT 7 smart<\/strong><\/p>\n<p><span class=\"title-grey\">Technology<\/span><br \/>\nDissolution<\/p>\n<p><span class=\"title-grey\">Capability<\/span><br \/>\n2 systems<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-5169","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Manufacturing - Abiogen<\/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:\/\/www.abiogen.it\/en\/manufacturing\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" 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