{"id":1679,"date":"2024-06-03T05:53:18","date_gmt":"2024-06-03T05:53:18","guid":{"rendered":"https:\/\/pfanstiehl.com\/?post_type=solutions&#038;p=1679"},"modified":"2025-10-26T00:14:42","modified_gmt":"2025-10-26T00:14:42","slug":"polysorbate-degradation-mitigation","status":"publish","type":"solutions","link":"https:\/\/pfanstiehl.com\/en\/solutions\/polysorbate-degradation-mitigation\/","title":{"rendered":"Polysorbate Degradation Mitigation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1679\" class=\"elementor elementor-1679\" data-elementor-post-type=\"solutions\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3c4dd17b e-flex e-con-boxed e-con e-parent\" data-id=\"3c4dd17b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2a73dd8c e-flex e-con-boxed e-con e-child\" data-id=\"2a73dd8c\" 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-4152c960 elementor-widget elementor-widget-heading\" data-id=\"4152c960\" 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\">Trace Metals in Excipients Can Degrade Polysorbates <br><br>Pfanstiehl Actively Reduces Trace Metals to Single Digit PPB which can Protect Polysorbates.<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-424f17af elementor-widget elementor-widget-text-editor\" data-id=\"424f17af\" 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<h4><strong>A 2024 study published (doi: 10.1016\/j.ejpb.2024.114521.)\u00a0that even trace amounts of iron (Fe) in a histidine\/polysorbate buffer can significantly accelerate polysorbate degradation.<\/strong><\/h4><p>\u00a0<\/p><p>Surfactants are critical components in pharmaceutical formulations.\u00a0 They reduce surface tension between different phases, aiding in the solubilization, stabilization, and dispersion of active pharmaceutical ingredients (APIs). However, the presence of trace metals can significantly impact the stability and degradation of surfactants, thereby affecting the overall stability and efficacy of the pharmaceutical product.<\/p>\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-145f063d e-flex e-con-boxed e-con e-child\" data-id=\"145f063d\" 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-12208a2c elementor-widget elementor-widget-image\" data-id=\"12208a2c\" 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 fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/sol-1024x576.jpeg\" class=\"attachment-large size-large wp-image-3481\" alt=\"Monoclonal Antibody in final formulation buffer with polysorbate 80\" srcset=\"https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/sol-1024x576.jpeg 1024w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/sol-300x169.jpeg 300w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/sol-768x432.jpeg 768w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/sol-1536x864.jpeg 1536w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/sol-2048x1152.jpeg 2048w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/sol-600x338.jpeg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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-7df42d2 e-flex e-con-boxed e-con e-parent\" data-id=\"7df42d2\" 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-56ee037 elementor-widget elementor-widget-heading\" data-id=\"56ee037\" 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\">Mechanisms of Surfactant Degradation Induced by Trace Metals<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-76b9351 e-con-full e-flex e-con e-child\" data-id=\"76b9351\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ee9d5cf e-flex e-con-boxed e-con e-child\" data-id=\"ee9d5cf\" 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-ebf8ad7 elementor-widget elementor-widget-text-editor\" data-id=\"ebf8ad7\" 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>Catalytic Degradation by Reactive Oxygen Species:<\/h4><p>Trace metals such as iron (Fe), copper (Cu), and manganese (Mn) can catalyze the formation of reactive oxygen species (ROS), including hydroxyl radicals (\u2022OH) and superoxide anions (O2\u2022\u2212). These ROS are highly reactive and can initiate oxidative degradation of surfactants. For example, iron ions can participate in Fenton-like reactions to generate hydroxyl radicals:<\/p><p>\u00a0<\/p><p>Fe2++H2O2\u2192Fe3++\u22c5OH+OH\u2212Fe2++H2\u200bO2\u200b\u2192Fe3++\u22c5OH+OH\u2212<\/p><p>\u00a0<\/p><p>Reactive hydroxyl radicals lead to oxidation-induced degradation of surfactants like polysorbate 80 (PS80), compromising their functionality and stability.<\/p>\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-6566ab8 e-flex e-con-boxed e-con e-child\" data-id=\"6566ab8\" 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-a47c391 elementor-widget elementor-widget-text-editor\" data-id=\"a47c391\" 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>Metal-Surfactant Complex Formation:<\/h4><p>Trace metals can bind directly to surfactant molecules, forming complexes that alter their physical and chemical properties, such as solubility and surface activity. This binding can reduce the surfactant&#8217;s efficiency in lowering surface tension and stabilizing emulsions or suspensions.<\/p>\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<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ac6a38b elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ac6a38b\" 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 *\/\n.elementor-widget-divider{--divider-border-style:none;--divider-border-width:1px;--divider-color:#0c0d0e;--divider-icon-size:20px;--divider-element-spacing:10px;--divider-pattern-height:24px;--divider-pattern-size:20px;--divider-pattern-url:none;--divider-pattern-repeat:repeat-x}.elementor-widget-divider .elementor-divider{display:flex}.elementor-widget-divider .elementor-divider__text{font-size:15px;line-height:1;max-width:95%}.elementor-widget-divider .elementor-divider__element{margin:0 var(--divider-element-spacing);flex-shrink:0}.elementor-widget-divider .elementor-icon{font-size:var(--divider-icon-size)}.elementor-widget-divider .elementor-divider-separator{display:flex;margin:0;direction:ltr}.elementor-widget-divider--view-line_icon .elementor-divider-separator,.elementor-widget-divider--view-line_text .elementor-divider-separator{align-items:center}.elementor-widget-divider--view-line_icon .elementor-divider-separator:after,.elementor-widget-divider--view-line_icon .elementor-divider-separator:before,.elementor-widget-divider--view-line_text .elementor-divider-separator:after,.elementor-widget-divider--view-line_text .elementor-divider-separator:before{display:block;content:\"\";border-block-end:0;flex-grow:1;border-block-start:var(--divider-border-width) var(--divider-border-style) var(--divider-color)}.elementor-widget-divider--element-align-left .elementor-divider .elementor-divider-separator>.elementor-divider__svg:first-of-type{flex-grow:0;flex-shrink:100}.elementor-widget-divider--element-align-left .elementor-divider-separator:before{content:none}.elementor-widget-divider--element-align-left .elementor-divider__element{margin-left:0}.elementor-widget-divider--element-align-right .elementor-divider .elementor-divider-separator>.elementor-divider__svg:last-of-type{flex-grow:0;flex-shrink:100}.elementor-widget-divider--element-align-right .elementor-divider-separator:after{content:none}.elementor-widget-divider--element-align-right .elementor-divider__element{margin-right:0}.elementor-widget-divider--element-align-start .elementor-divider .elementor-divider-separator>.elementor-divider__svg:first-of-type{flex-grow:0;flex-shrink:100}.elementor-widget-divider--element-align-start .elementor-divider-separator:before{content:none}.elementor-widget-divider--element-align-start .elementor-divider__element{margin-inline-start:0}.elementor-widget-divider--element-align-end .elementor-divider .elementor-divider-separator>.elementor-divider__svg:last-of-type{flex-grow:0;flex-shrink:100}.elementor-widget-divider--element-align-end .elementor-divider-separator:after{content:none}.elementor-widget-divider--element-align-end .elementor-divider__element{margin-inline-end:0}.elementor-widget-divider:not(.elementor-widget-divider--view-line_text):not(.elementor-widget-divider--view-line_icon) .elementor-divider-separator{border-block-start:var(--divider-border-width) var(--divider-border-style) 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) 100%;-webkit-mask-repeat:var(--divider-pattern-repeat);mask-repeat:var(--divider-pattern-repeat);background-color:var(--divider-color);-webkit-mask-image:var(--divider-pattern-url);mask-image:var(--divider-pattern-url)}.elementor-widget-divider--no-spacing{--divider-pattern-size:auto}.elementor-widget-divider--bg-round{--divider-pattern-repeat:round}.rtl .elementor-widget-divider .elementor-divider__text{direction:rtl}.e-con-inner>.elementor-widget-divider,.e-con>.elementor-widget-divider{width:var(--container-widget-width,100%);--flex-grow:var(--container-widget-flex-grow)}<\/style>\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-09889a0 e-flex e-con-boxed e-con e-parent\" data-id=\"09889a0\" 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-7b2c112 elementor-widget elementor-widget-text-editor\" data-id=\"7b2c112\" 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>Impact of Trace Metals on Protein Stability and Therapeutic Efficacy<\/h3><p>The presence of trace metals not only affects surfactants but also has significant implications for protein stability and therapeutic efficacy in drug substances (DS) and drug products (DP):<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-63f5208 e-con-full e-flex e-con e-child\" data-id=\"63f5208\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-2a309ac e-flex e-con-boxed e-con e-child\" data-id=\"2a309ac\" 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-a53b53d elementor-widget elementor-widget-text-editor\" data-id=\"a53b53d\" 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>Protein Fragmentation:<\/h4><p>Iron (Fe), in particular, can induce protein fragmentation through oxidative mechanisms. The generated ROS can attack protein molecules, leading to fragmentation and degradation. This can dramatically affect the stability and therapeutic efficacy of protein-based drugs.<\/p>\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-5b5b09a e-flex e-con-boxed e-con e-child\" data-id=\"5b5b09a\" 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-089a5be elementor-widget elementor-widget-text-editor\" data-id=\"089a5be\" 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>Reduced Therapeutic Efficacy:<\/h4><p>The degradation of surfactants and fragmentation of proteins compromise the stability and integrity of pharmaceutical formulations. This can lead to reduced therapeutic efficacy and potential safety concerns, as the degraded components may exhibit altered or diminished biological activity.<\/p>\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<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15dd608 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"15dd608\" 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-3aee7d4 e-flex e-con-boxed e-con e-parent\" data-id=\"3aee7d4\" 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-21dbc9f elementor-widget elementor-widget-text-editor\" data-id=\"21dbc9f\" 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>Importance of Using the Purest Excipients<\/h3><p>Given the potential adverse effects of trace metals on surfactants and proteins, it is crucial to use excipients (inactive ingredients) of the highest purity in biologics formulations:<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-af39dd6 e-con-full e-flex e-con e-child\" data-id=\"af39dd6\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-0f13c90 e-flex e-con-boxed e-con e-child\" data-id=\"0f13c90\" 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-ec0d5c9 elementor-widget elementor-widget-text-editor\" data-id=\"ec0d5c9\" 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>Stability of Formulation:<\/h4><p>Pure excipients minimize the risk of trace metal-induced degradation, ensuring the long-term stability of the formulation. This is particularly important for products with extended shelf lives or those exposed to varying environmental conditions<\/p>\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-d56f866 e-flex e-con-boxed e-con e-child\" data-id=\"d56f866\" 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-2655903 elementor-widget elementor-widget-text-editor\" data-id=\"2655903\" 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>Efficacy and Safety:<\/h4><p>Impurities in excipients, including trace metals, can interact with APIs, affecting the therapeutic efficacy and safety of the product. High-purity excipients help maintain the intended performance and safety profile of the drug.<\/p>\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<\/div>\n\t\t<div class=\"elementor-element elementor-element-15cb6d3 e-con-full e-flex e-con e-child\" data-id=\"15cb6d3\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-8e78762 e-flex e-con-boxed e-con e-child\" data-id=\"8e78762\" 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-0280a53 elementor-widget elementor-widget-text-editor\" data-id=\"0280a53\" 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>Regulatory Compliance:<\/h4><p>Pharmaceutical products must meet stringent regulatory standards for quality and purity. Using high-purity excipients helps in meeting these standards and avoiding costly recalls or rejections due to stability issues or contamination.<\/p>\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-ad20904 e-flex e-con-boxed e-con e-child\" data-id=\"ad20904\" 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-c41324d elementor-widget elementor-widget-text-editor\" data-id=\"c41324d\" 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>Consistent Performance:<\/h4><p>Ensuring the purity of excipients leads to more consistent manufacturing outcomes and product performance. Variations in trace metal levels can result in batch-to-batch variability, affecting the reliability of the pharmaceutical product.<\/p>\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<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d0f4184 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"d0f4184\" 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-780fdda e-flex e-con-boxed e-con e-parent\" data-id=\"780fdda\" 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-8fe922e elementor-widget elementor-widget-text-editor\" data-id=\"8fe922e\" 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 style=\"text-align: center;\"><strong>Pfanstiehl\u2019s Proprietary Process for Reducing Trace Metal Impurities:\u00a0<\/strong><\/h3><h3 style=\"text-align: center;\"><strong> Single-Digit ppb<\/strong><\/h3><p>Pfanstiehl\u2019s industry-leading, proprietary processes allow us to produce cell culture ingredients and cGMP parenteral excipients with exceptionally low levels of Trace Metal impurities. By reducing impurities to single-digit ppb level &#8211; 100 to 1000 times lower than traditional industry standards \u2013 Pfanstiehl\u2019s products provide a new benchmark for purity in therapeutic biologic production.<\/p><p>\u00a0<\/p><p>These <strong>ultralow levels of impurities<\/strong> bring a host of critical advantages:<\/p><p>\u00a0<\/p><p><strong>Higher Protein Yields:<\/strong> Lower impurities in cell culture ingredients lead to healthier cells, reduced oxidative stress, and higher yields of biologically active proteins.<\/p><p>\u00a0<\/p><p><strong>Improved Consistency and Quality:<\/strong> The reduction of elemental impurities ensures more consistent product quality, reducing batch-to-batch variability and ensuring higher levels of regulatory compliance.<\/p><p>\u00a0<\/p><p><strong>Minimized Risks in Final Formulation:<\/strong> By using excipients with minimal impurities, manufacturers reduce the likelihood of protein degradation, aggregation, or immunogenicity in the final drug product, improving overall therapeutic efficacy and safety.<\/p><p>\u00a0<\/p>\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-03e24c2 e-flex e-con-boxed e-con e-parent\" data-id=\"03e24c2\" 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-7cacc5a elementor-widget elementor-widget-text-editor\" data-id=\"7cacc5a\" 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>Pfanstiehl High Purity, Low Endotoxin, Low Metals Excipients Can Help<\/h4><p>Pfanstiehl\u2019s Technical Sales Scientists can discuss with you to understand your challenges and provide guidance based on experience and literature reviews to reduce surfactant degradation and stabilize the structure and biologic activity of your protein therapeutic.<\/p><p>Let us help put together some ideas for:<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7b380ed solutions_content_box e-flex e-con-boxed e-con e-child\" data-id=\"7b380ed\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7875f01 e-flex e-con-boxed e-con e-child\" data-id=\"7875f01\" 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-bb0e317 elementor-widget elementor-widget-text-editor\" data-id=\"bb0e317\" 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>Utilizing Metal Chelators:<\/h4><p>in combination with other high purity excipients, Pfanstiehl high purity low metal amino acids like Pfanstiehl\u00a0 L-Methionine, in low concentrations, can act as chelators and sequester trace metals and thereby reducing risk for surfactant degradation.<\/p><p><a href=\"https:\/\/pfanstiehl.com\/high-purity-ingredients\/l-methionine\/\">Pfanstiehl HPLE-LM<sup>TM<\/sup>\u00a0L-Methionine<\/a><\/p>\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-078d9f8 e-flex e-con-boxed e-con e-child\" data-id=\"078d9f8\" 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-8dba9c6 elementor-widget elementor-widget-text-editor\" data-id=\"8dba9c6\" 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>Optimizing Buffer Systems:<\/h4><p>Adjusting the buffer system&#8217;s pH and composition can enhance solubility and stability, crucial for high concentration formulations.<\/p><p><a href=\"https:\/\/pfanstiehl.com\/high-purity-ingredients\/tris-base\/\">Pfanstiehl HPLE-LM<sup>TM<\/sup> TRIS Base<\/a><br \/><a href=\"https:\/\/pfanstiehl.com\/high-purity-ingredients\/tris-hcl\/\">Pfanstiehl HPLE-LM<sup>TM<\/sup> Tris HCL<\/a><br \/><a href=\"https:\/\/pfanstiehl.com\/en\/high-purity-ingredients\/sodium-succinate-hexahydrate\/\">Pfanstiehl HPLE-LM\u2122 Sodium Succinate Hexahydrate<\/a><\/p><p><a href=\"https:\/\/pfanstiehl.com\/en\/high-purity-ingredients\/succinic-acid\/\">Pfanstiehl HPLE-LM\u2122 Succinic Acid<\/a><\/p>\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-9be0b22 e-flex e-con-boxed e-con e-child\" data-id=\"9be0b22\" 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-c27379a elementor-widget elementor-widget-text-editor\" data-id=\"c27379a\" 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>Utilizing Highest Purity Excipients and Stabilizing Agents:<\/h4><p>Incorporating the combination of the highest purity &amp; lowest metals excipients such as Pfanstiehl Sucrose and Pfanstiehl L-Histidine, can greatly reduce the risk of surfactant degradation.<\/p><p><a href=\"https:\/\/pfanstiehl.com\/high-purity-ingredients\/sucrose\/\">Pfanstiehl HPLE-LM<sup>TM<\/sup> Sucrose<\/a><br \/><a href=\"https:\/\/pfanstiehl.com\/high-purity-ingredients\/histidine\/\">Pfanstiehl HPLE-LM<sup>TM<\/sup>\u00a0L-Histidine<\/a><br \/><a href=\"https:\/\/pfanstiehl.com\/high-purity-ingredients\/histidine-hcl\/\">Pfanstiehl HPLE-LM<sup>TM<\/sup>\u00a0L-Histidine HCL<\/a><\/p>\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<div class=\"elementor-element elementor-element-d5ca35c elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"d5ca35c\" 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-1cff2a1d e-flex e-con-boxed e-con e-parent\" data-id=\"1cff2a1d\" 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-3b2b6005 elementor-widget elementor-widget-text-editor\" data-id=\"3b2b6005\" 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>For over 100 years, Pfanstiehl has made cGMP Injectable grade excipients, stabilizers, and buffer components that are guaranteed high purity, low endotoxin, and low in transition metals.<\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27a084d elementor-widget elementor-widget-text-editor\" data-id=\"27a084d\" 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>Pfanstiehl components are used in the majority of the world\u2019s top selling biopharmaceuticals and we continue to grow every year.<\/p><p>\u00a0<\/p><p>Our customers know that the combination of Pfanstiehl\u2019s award winning technical support and high purity low endotoxin low metals cGMP excipients, amino acids, and buffer salts, will help ensure better consistency from batch to batch and reduce the risk of manufacturing batch failure for your therapeutic.<\/p><p>\u00a0<\/p><p>If you have a protein biologic or vaccine that requires a surfactant in the final formulation, please contact us and we will be happy to discuss how we can work together to 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