{"id":137,"date":"2022-10-03T11:18:57","date_gmt":"2022-10-03T11:18:57","guid":{"rendered":"https:\/\/theragent.com\/?page_id=137"},"modified":"2024-03-28T12:40:54","modified_gmt":"2024-03-28T12:40:54","slug":"process-development","status":"publish","type":"page","link":"https:\/\/theragent.com\/services\/process-development\/","title":{"rendered":"Process Development"},"content":{"rendered":"<header id=\"image-header-block-block_128a4c97657577336f9743b72afe7054\" class=\"image-header-block style-text-left-angle-bg height-default\">\n    <div class=\"bg\" style=\"background-image:url(https:\/\/theragent.com\/wp-content\/uploads\/2022\/10\/Hero-Process-Dev-2000x1125.jpg); background-position: 50% 50%;\"><\/div>\n    <div class=\"text\"><div>\n        <div>\n            <div class=\"pre-headline\">Process Development<\/div>            <h2>We help you get the process right, the&nbsp;first time.<\/h2>                        <p>The goal of any process development scientist is to end with a robust, scalable  process that will ensure consistent, high-quality product with reduced risk and  acceptable cost of goods \u2013 all while meeting tight timelines. The ability to achieve this delicate balance comes with experience, which we share with you during the development of pre-clinical and clinical cell therapy processes to help you reach the therapeutic promise of your candidate.<\/p>\n                    <\/div>\n            <\/div><\/div>\n<\/header>\n\n\n<div class=\"wp-block-group is-style-small-centered has-light-gray-background-color has-background is-layout-flow wp-block-group-is-layout-flow\">\n<h3 class=\"wp-block-heading\"><strong>The Approach<\/strong><\/h3>\n\n\n\n<p>Designing the process with manufacturability in mind is critical. We start with a wide process characterization\u00a0lens, beginning with the Critical Quality Attributes (CQA\u2019s). Then, by establishing\u00a0Critical Process Parameters (CPP\u2019s), we can thoughtfully design your process while\u00a0considering scalability and media optimization strategies.<\/p>\n<\/div>\n\n\n<div id=\"four-lists-block-block_6cc32a700c5d38cc93ea76fd09c5dcb9\" class=\"four-lists-block\"><div>\n                <div class=\"list list-1\">\n                <aside>1<\/aside>\n                <div>\n                    <h4>Setting the Criteria<\/h4>\n                    <ul><li>Understand CQA\u2019s<\/li><li>Establish CPP\u2019s<\/li><li>Product specifications<\/li><\/ul>                <\/div>\n            <\/div>\n                    <div class=\"list list-2\">\n                <aside>2<\/aside>\n                <div>\n                    <h4>Design for the Right Scalability<\/h4>\n                    <ul><li>Scale out \/ scale up<\/li><li>2D or 3D cell culture<\/li><li>Closing up the process<\/li><\/ul>                <\/div>\n            <\/div>\n                    <div class=\"list list-3\">\n                <aside>3<\/aside>\n                <div>\n                    <h4>Reagent Optimization<\/h4>\n                    <ul><li>Risk mitigation<\/li><li>Feeding strategies<\/li><li>QbD \/ DOE Studies<\/li><\/ul>                <\/div>\n            <\/div>\n                    <div class=\"list list-4\">\n                <aside>4<\/aside>\n                <div>\n                    <h4>Develop\/Optimize the Process<\/h4>\n                    <ul><li>Cell isolation\/enrichment<\/li><li>Cell modification and expansion<\/li><li>Cell transfection\/transduction<\/li><\/ul>                <\/div>\n            <\/div>\n        <svg class=\"svg-icon logo-plus\" width=\"24\" height=\"24\" aria-hidden=\"true\" role=\"img\" focusable=\"false\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" x=\"0px\" y=\"0px\" viewBox=\"0 0 64 64\"><path d=\"M0.7,32.7c0,1.7,1.3,3.1,3.1,3.1c1.7,0,3.2-1.3,3.2-3c0-1.7-1.3-3.1-3.1-3.2C2.1,29.6,0.7,31,0.7,32.7\"\/><path d=\"M32.5,22.2c-2.1,0-3.7,1.7-3.7,3.7c0,2.1,1.7,3.7,3.7,3.7c2,0,3.7-1.6,3.7-3.7C36.3,23.9,34.6,22.2,32.5,22.2\" \/><path d=\"M46.3,29.1c-2.1,0-3.7,1.7-3.7,3.7c0,2.1,1.7,3.7,3.7,3.7c2,0,3.7-1.6,3.7-3.7C50,30.7,48.3,29.1,46.3,29.1\"\/><path d=\"M17.7,29.1c-2,0-3.7,1.7-3.7,3.7c0,2.1,1.7,3.7,3.7,3.7c2.1,0,3.7-1.6,3.7-3.7C21.4,30.7,19.8,29.1,17.7,29.1\" \/><path d=\"M32.5,35.9c-2.1,0-3.7,1.6-3.7,3.7c0,2,1.7,3.7,3.7,3.7c2,0,3.7-1.6,3.7-3.7C36.3,37.5,34.6,35.9,32.5,35.9\"\/><path d=\"M31.5,6.5l0,3.6c-0.2,0-0.3,0.1-0.5,0.2c-1.4,0.8-1.9,2.5-1.2,3.9c0.8,1.4,2.6,1.9,4,1.1 c1.4-0.8,1.9-2.5,1.1-3.9c-0.4-0.7-1-1.1-1.7-1.4l0.1-3.5c0.3-0.1,0.6-0.2,0.9-0.3c1.6-0.9,2.1-2.8,1.2-4.4 c-0.9-1.5-2.8-2.1-4.4-1.2c-1.6,0.9-2.2,2.8-1.3,4.4C30.1,5.7,30.8,6.3,31.5,6.5\"\/><path d=\"M63.3,32.8c0-1.7-1.3-3.1-3.1-3.2c-1.7,0-3.2,1.3-3.2,3c0,1.7,1.3,3.1,3,3.1C61.9,35.9,63.3,34.5,63.3,32.8\"\/><path d=\"M32.5,47.5c-2,0-3.6,1.6-3.6,3.5c0,2,1.6,3.5,3.6,3.5c1.9,0,3.6-1.6,3.6-3.5C36.1,49.1,34.5,47.5,32.5,47.5\"\/><path d=\"M32.5,57.3c-1.8,0-3.3,1.5-3.3,3.2c0,1.8,1.5,3.2,3.3,3.2c1.8,0,3.3-1.4,3.3-3.2 C35.8,58.7,34.3,57.3,32.5,57.3\"\/><\/svg><\/div><\/div>\n\n\n<div id=\"col-w-angle-image-block-block_e99f876c66995c285b210dbe98d2ef92\" class=\"col-w-angle-image-block style-image-right image-adj-0\">\n        <div class=\"colwai-image\" style=\"background-image: url(https:\/\/theragent.com\/wp-content\/uploads\/2022\/10\/Process-Dev-3-1466x1438.jpg); background-position: 0% 50%;\"><\/div>\n    <div class=\"colwai-copy\"><div><div>\n        <h3>Process Development<\/h3>\n<p>Do you have an existing manual process that would benefit from automation? Perhaps an open culture system that you wish to be functionally closed? Limited procedures? Let Theragent\u2019s Process Development team design and improve your process to set your future manufacturing up for success. Drawing upon our collective past of developing programs for T-cells, NK cells, iPSC\u2019s, and more, leverage our process science know-how to provide you with a more robust process using modern tools and the latest media and reagents.<\/p>\n<p>Additionally, our process development team is co-located with our analytical development group, so we can provide the best analytical tools for your cell type in a cohesive manner.<\/p>\n<p><strong><a href=\"\/services\/analytical-development\/\">Learn more about our analytical<br \/>\ndevelopment services&#8230;<\/a><\/strong><\/p>\n    <\/div><\/div><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The goal of any process development scientist is to end with a robust, scalable  process that will ensure consistent, high-quality product with reduced risk and  acceptable cost of goods \u2013 all while meeting tight timelines. The ability to achieve this delicate balance comes with experience, which we share with you during the development of pre-clinical and clinical cell therapy processes to help you reach the therapeutic promise of your candidate.<\/p>\n","protected":false},"author":1,"featured_media":503,"parent":21,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"acf":[],"_links":{"self":[{"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages\/137"}],"collection":[{"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/comments?post=137"}],"version-history":[{"count":22,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages\/137\/revisions"}],"predecessor-version":[{"id":955,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages\/137\/revisions\/955"}],"up":[{"embeddable":true,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages\/21"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/media\/503"}],"wp:attachment":[{"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/media?parent=137"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}