{"id":1835,"date":"2024-06-04T10:45:38","date_gmt":"2024-06-04T10:45:38","guid":{"rendered":"https:\/\/pfanstiehl.com\/?post_type=services&#038;p=1835"},"modified":"2024-06-19T04:33:18","modified_gmt":"2024-06-19T04:33:18","slug":"custom-api-manufacture","status":"publish","type":"services","link":"https:\/\/pfanstiehl.com\/en\/services\/custom-api-manufacture\/","title":{"rendered":"Custom API Manufacturing"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1835\" class=\"elementor elementor-1835\" data-elementor-post-type=\"services\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5b559dae e-flex e-con-boxed e-con e-parent\" data-id=\"5b559dae\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-3dc305b7 e-flex e-con-boxed e-con e-child\" data-id=\"3dc305b7\" 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-46c884d0 elementor-widget elementor-widget-heading\" data-id=\"46c884d0\" 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\">Pfanstiehl Custom Active Pharmaceutical Ingredient Manufacturing Services<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-603b027b elementor-widget elementor-widget-text-editor\" data-id=\"603b027b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>With a long successful track record in custom Active Pharmaceutical Ingredient (API) manufacturing, Pfanstiehl has established itself as a trusted partner committed to delivering solutions tailored to the unique needs of our clients. Our history is rich with innovation and excellence, spanning decades of experience in supporting the pharmaceutical industry. At Pfanstiehl, we understand the critical importance of fostering strong partnerships and ensuring customer satisfaction at every stage of the manufacturing process. From product inception to on-market supply, we are dedicated to providing comprehensive support that exceeds expectations.<\/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-792518e3 e-flex e-con-boxed e-con e-child\" data-id=\"792518e3\" 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-5da69788 elementor-widget elementor-widget-image\" data-id=\"5da69788\" 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=\"491\" src=\"https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/custom-api-1024x629.png\" class=\"attachment-large size-large wp-image-2207\" alt=\"\" srcset=\"https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/custom-api-1024x629.png 1024w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/custom-api-300x184.png 300w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/custom-api-768x472.png 768w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/custom-api-600x368.png 600w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/custom-api.png 1140w\" 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-10089930 e-flex e-con-boxed e-con e-parent\" data-id=\"10089930\" 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-661635a9 elementor-widget elementor-widget-text-editor\" data-id=\"661635a9\" 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>When you partner with Pfanstiehl for custom API manufacturing, you work side-by-side with our seasoned scientists with extensive expertise in chemistry and a track record of success in supporting various stages of clinical development programs and commercial-scale manufacturing.\u00a0<\/p><p>\u00a0<\/p><p>Pfanstiehl\u2019s Custom API Development and Manufacturing services encompass a wide range of capabilities tailored to meet your specific needs:<\/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-4517cf7b solutions_content_box e-flex e-con-boxed e-con e-parent\" data-id=\"4517cf7b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-1dfd1950 e-flex e-con-boxed e-con e-child\" data-id=\"1dfd1950\" 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-3414faf5 elementor-widget elementor-widget-text-editor\" data-id=\"3414faf5\" 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>Early- and Late-phase Clinical Support:<\/h4><p>Our scientists provide comprehensive support throughout early- and late-phase clinical development programs, ensuring seamless progression from preclinical studies to clinical trials.<\/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-5528f4fd e-flex e-con-boxed e-con e-child\" data-id=\"5528f4fd\" 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-41fb90fe elementor-widget elementor-widget-text-editor\" data-id=\"41fb90fe\" 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>Multistep Chemical Synthesis:<\/h4><p>We excel in both traditional and complex API manufacturing, utilizing cutting-edge capabilities to execute multistep chemical synthesis processes.<\/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-63cafff1 e-flex e-con-boxed e-con e-child\" data-id=\"63cafff1\" 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-4a4e4f74 elementor-widget elementor-widget-text-editor\" data-id=\"4a4e4f74\" 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>Scale Flexibility:<\/h4><p>From lab-scale to kilo-scale and pilot-scale manufacturing, we continuously refine &amp; optimize our processes while supplying a wide range of quantities through all phases of development.<\/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-27ba29cf e-flex e-con-boxed e-con e-child\" data-id=\"27ba29cf\" 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-451c9ac8 elementor-widget elementor-widget-text-editor\" data-id=\"451c9ac8\" 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>Commercial Manufacturing Support:<\/h4>\nFrom product launch to on-market supply, Pfanstiehl is committed to supporting commercial manufacturing needs. With current capacities, we can produce quantities up to 70KG.\u00a0 Pfanstiehl will ensure consistent and reliable supply to meet market demand.\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-6ffbb502 e-flex e-con-boxed e-con e-child\" data-id=\"6ffbb502\" 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-6c8a5ce1 elementor-widget elementor-widget-text-editor\" data-id=\"6c8a5ce1\" 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>cGMP Compliance:<\/h4><p>Pfanstiehl\u2019s operations adhere strictly to cGMP standards, reflecting an unwavering commitment to quality and regulatory compliance. Our proven track record demonstrates our dedication to maintaining the highest standards of manufacturing excellence.<\/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-76e2818 e-flex e-con-boxed e-con e-child\" data-id=\"76e2818\" 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-45911db6 elementor-widget elementor-widget-text-editor\" data-id=\"45911db6\" 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>Scale-up Expertise:<\/h4><p>Our team offers comprehensive scale-up capabilities, supported by a full range of analytical services. We prioritize flexibility, ensuring timely execution with exceptional yields and superior quality at every stage of the scale-up process.<\/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-7853e2b2 e-flex e-con-boxed e-con e-child\" data-id=\"7853e2b2\" 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-32cdb9c0 elementor-widget elementor-widget-text-editor\" data-id=\"32cdb9c0\" 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>Development to Commercialization:<\/h4><p>Leveraging our extensive commercial API manufacturing capabilities, we guide your project seamlessly from development to scale-up and commercial production. Our integrated approach streamlines the transition, minimizing risk and accelerating time to market.<\/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<div class=\"elementor-element elementor-element-11f73f14 e-flex e-con-boxed e-con e-parent\" data-id=\"11f73f14\" 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-29cf2468 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"29cf2468\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 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var(--divider-color)}.elementor-widget-divider--separator-type-pattern{--divider-border-style:none}.elementor-widget-divider--separator-type-pattern.elementor-widget-divider--view-line .elementor-divider-separator,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:after,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:before,.elementor-widget-divider--separator-type-pattern:not([class*=elementor-widget-divider--view]) .elementor-divider-separator{width:100%;min-height:var(--divider-pattern-height);-webkit-mask-size:var(--divider-pattern-size) 100%;mask-size:var(--divider-pattern-size) 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-137f91ab e-flex e-con-boxed e-con e-parent\" data-id=\"137f91ab\" 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-61efb101 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"61efb101\" 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>Pfanstiehl Custom API Manufacturing Capabilities Overview<\/h3><ul><li>Potent API drug manufacturing facility scale:\u00a0 1 to 70kg<\/li><li>Pilot manufacturing: up to 300 gallon reactors<\/li><li>Full scale (2,000 gallon), explosion-proof facility for processing with flammable solvents<\/li><li>Solvent recovery facility<\/li><li>Time-tested API development process:<\/li><\/ul><p>\u00a0<\/p><ul><li style=\"list-style-type: none;\"><ul><li style=\"list-style-type: none;\"><ul><li>Process Development, Scale-up, Optimization, &amp; Validation<\/li><li>cGMP Documentation<\/li><li>Analytical Test Method &amp; Validation<\/li><li>ICH Compliant Stability Testing<\/li><li>Drug Master File (DMF) Development &amp; Validation<\/li><\/ul><\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6676d54e elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"6676d54e\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37aade6e elementor-widget elementor-widget-heading\" data-id=\"37aade6e\" 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\">Areas of Special Expertise<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-680a247e solutions_content_box e-flex e-con-boxed e-con e-child\" data-id=\"680a247e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-482f26f5 e-flex e-con-boxed e-con e-child\" data-id=\"482f26f5\" 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-3b2ddeea padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"3b2ddeea\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<strong style=\"display: block; margin-bottom: 10px;\">Pharmaceutical:<\/strong>\n<ul>\n \t<li>Development and manufacturing of API and HPAPI<\/li>\n \t<li>Advanced intermediates<\/li>\n \t<li>Potent \/ Cytotoxic compounds<\/li>\n \t<li>Linker-Toxins to support ADC manufacture<\/li>\n \t<li>Nucleoside chemistry \u2013 Generic APIs<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1db5bf50 e-flex e-con-boxed e-con e-child\" data-id=\"1db5bf50\" 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-66216c74 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"66216c74\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<strong style=\"display:block; margin-bottom: 10px;\">Biopharmaceutical:<\/strong>\n<ul>\n \t<li>Carbohydrate Chemistry \/ Rare and Blocked Sugars<\/li>\n \t<li>Protein Stabilizers \/ Parenteral Grade Excipients<\/li>\n \t<li>Bioprocessing Components<\/li>\n \t<li>Drug Delivery \/ Solubilizers<\/li>\n \t<li>Vaccine Stabilizers<\/li>\n \t<li>Lyoprotectants<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-484bb473 e-flex e-con-boxed e-con e-parent\" data-id=\"484bb473\" 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-4b44ec8b padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"4b44ec8b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<strong style=\"display: block; margin-bottom: 10px;\">Process Development Highlights:<\/strong>\n<ul>\n \t<li>Rapid chemical process development and route optimization, with an emphasis on SafeBridge process safety<\/li>\n \t<li>Experience and expertise to overcome process bottlenecks and facilitate process improvements<\/li>\n \t<li>Process development focus on yields, scalability, safety, limited environmental impact, and economics<\/li>\n \t<li>Process scale-up and validation support<\/li>\n \t<li>Small scale SMB development<\/li>\n \t<li>Lab-scale non-cGMP custom synthesis<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-73279ca8 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"73279ca8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<strong style=\"display: block; margin-bottom: 10px;\">Analytical Services Include:<\/strong>\n<ul>\n \t<li>Analytical method development and validation:\n<ul style=\"margin: 14px 0;\">\n \t<li style=\"list-style-type: none;\">\n<ul>\n \t<li>Assay\/release specification development for streamlined multi-compendial release<\/li>\n \t<li>Impurity profiling<\/li>\n \t<li>Structural analysis<\/li>\n \t<li>Endotoxin and Glucan detection method development and validation<\/li>\n \t<li>Elemental impurities quantitation at low ppb levels<\/li>\n \t<li>Nitrosamine concentration, and N-Nitroso-structural impurities, nitrite concentration<\/li>\n \t<li>DNA\/RNA\/DNase\/RNase detection and validation<\/li>\n \t<li>Reference standard qualification<\/li>\n \t<li>Cleaning method development and validation<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n \t<li>ICH stability testing and protocol development<\/li>\n \t<li>Impurity marker characterization<\/li>\n \t<li>KYPP Program to track and trend analytical quality attributes<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-158f280b elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"158f280b\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46efea57 elementor-widget elementor-widget-heading\" data-id=\"46efea57\" 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\">Facilities & Equipment<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-22684804 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"22684804\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong style=\"display: block; margin-bottom: 5px;\">KILO LAB MANUFACTURING<\/strong><\/p><p>Pfanstiehl has a multipurpose kilo lab containment facility on site including:<\/p><ul><li style=\"list-style-type: none;\"><ul style=\"margin-top: 10px;\"><li>Carlisle glove box synthesis isolator \u2013 Hastelloy C filter and contained tray drying<\/li><li>100 liter glass reactor in Howorth full containment fume booth<\/li><li>100 liter Hastelloy C hydrogenation reactor (50 psi)<\/li><li>Broad processing temperature range \u2013 (-)80\u00baC to (+)200\u00baC<\/li><li>Certified to handle compounds down to 0.10 ug\/m\u00b3 \u2013 SafeBridge Category 4 capable<\/li><li>Kilo-scale non-cGMP custom synthesis<\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-64c705c7 padding-li-5 elementor-widget elementor-widget-text-editor\" data-id=\"64c705c7\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong style=\"display: block; margin-bottom: 5px;\">PILOT AND COMMERCIAL SCALE MANUFACTURING<\/strong><\/p><p>Pfanstiehl is equipped with:<\/p><ul><li style=\"list-style-type: none;\"><ul><li>Large Scale High Potency Manufacturing \u2013 Class 100,000 \/ SafeBridge Category 1-3 production facility<\/li><li>Multiple glass-lined 300 gallon reactor trains, with a total primary reactor capacity of 1,500 gallons<\/li><li>Flexible cGMP plant can produce up to ~100 Kg lots of potent \/ cytotoxic drugs<\/li><li>New 0.4 m\u00b2 Hastelloy C Nutsche filter dryer with containment glove box isolator, as well as a multitude of portable Aurora filters (Hastelloy C and Stainless Steel)<\/li><li>Contained potent compound milling<\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1ba443cf e-flex e-con-boxed e-con e-parent\" data-id=\"1ba443cf\" 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-54d9aae7 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"54d9aae7\" 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-6e375bf0 e-flex e-con-boxed e-con e-parent\" data-id=\"6e375bf0\" 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-6f1ccf89 elementor-widget elementor-widget-text-editor\" data-id=\"6f1ccf89\" 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>By partnering with Pfanstiehl, you gain access to a reliable and experienced partner dedicated to delivering high-quality custom API manufacturing solutions on-time and on-budget.<\/p><p>\u00a0<\/p><p>Questions?\u00a0 Click the Contact Us button below and one of our Technical Support Scientists will be happy to assist.<\/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-eeb8990 elementor-widget elementor-widget-button\" data-id=\"eeb8990\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/pfanstiehl.com\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact Us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-54ef188d e-con-full 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