{"id":3266,"date":"2020-12-04T07:22:13","date_gmt":"2020-12-04T12:22:13","guid":{"rendered":"https:\/\/web.uri.edu\/pdi\/?page_id=3266"},"modified":"2023-07-20T08:52:07","modified_gmt":"2023-07-20T12:52:07","slug":"introduction-to-biopharmaceutical-manufacturing","status":"publish","type":"page","link":"https:\/\/web.uri.edu\/pdi\/training\/introduction-to-biopharmaceutical-manufacturing\/","title":{"rendered":"Introduction to Biopharmaceutical Manufacturing"},"content":{"rendered":"<p><section class=\"cl-wrapper cl-hero-wrapper\"><div class=\"cl-hero   cl-has-accessibility-controls\"><div class=\"cl-hero-proper\"><div class=\"overlay\"><div class=\"block\"><h1>Introduction to Biopharmaceutical Manufacturing<\/h1><p>Participants gain foundational expertise in upstream and downstream biopharmaceutical manufacturing processes<\/p><\/div><\/div><div class=\"still\" style=\"background-image:url(https:\/\/web.uri.edu\/wp-content\/uploads\/sites\/1340\/training-3.png);\"><\/div><div class=\"cl-accessibility-controls-container\"><div class=\"cl-accessibility-controls\"><div class=\"cl-accessibility-icon\" title=\"Accessibility controls\">Accessibility controls<\/div><div class=\"cl-accessibility-control cl-accessibility-motion-control cl-accessibility-control-hidden\"><div class=\"cl-accessibility-control-default\"><div class=\"cl-accessibility-control-button\" title=\"Pause motion\">Pause motion<\/div><div class=\"cl-accessibility-control-label\">Motion: <span class=\"cl-accessibility-syntax\">On<\/span><\/div><\/div><div class=\"cl-accessibility-control-alternate\"><div class=\"cl-accessibility-control-button\" title=\"Play motion\">Play motion<\/div><div class=\"cl-accessibility-control-label\">Motion: <span class=\"cl-accessibility-syntax\">Off<\/span><\/div><\/div><\/div><div class=\"cl-accessibility-control cl-accessibility-contrast-control\"><div class=\"cl-accessibility-control-default\"><div class=\"cl-accessibility-control-button\" title=\"Increase text contrast\">Increase text contrast<\/div><div class=\"cl-accessibility-control-label\">Contrast: <span class=\"cl-accessibility-syntax\">Standard<\/span><\/div><\/div><div class=\"cl-accessibility-control-alternate\"><div class=\"cl-accessibility-control-button\" title=\"Reset text contrast\">Reset text contrast<\/div><div class=\"cl-accessibility-control-label\">Contrast: <span class=\"cl-accessibility-syntax\">High<\/span><\/div><\/div><\/div><div class=\"cl-accessibility-system-setting\"><div class=\"cl-accessibility-toggle\" title=\"Apply my preferences site-wide\"><\/div><div class=\"cl-accessibility-toggle-label\">Apply site-wide<\/div><\/div><\/div><\/div><\/div><\/div><\/section><br \/>\n<div class=\"cl-wrapper cl-boxout-wrapper\"><div class=\"cl-boxout right  \"><h1>Want to know more?<\/h1><p><b>Email <a href=\"mailto:pdi@etal.uri.edu\">pdi@etal.uri.edu<\/a><br \/>\nor call 401.874.3114<\/b><br \/>\n<\/p><\/div><\/div>&nbsp;<\/p>\n<p>This course is designed for biopharmaceutical manufacturers to ensure employees achieve proficiencies in both upstream and downstream biopharmaceutical manufacturing. We begin with the foundational theories of biopharmaceutical processing, then move into the methodologies and principles of mammalian cell culture and aseptic upstream operations. Students learn hands-on techniques for growing and maintaining anchorage-dependent and suspension cell lines. They gain an understanding of the critical parameters involved in aseptic mammalian cell culture within various cell culture vessels, including 2 L bioreactors. Continuing into downstream manufacturing, students learn chromatography basics that specifically apply to biopharmaceutical protein purification. Chromatography resins and applications, as well as hands-on column packing and protein purification are all covered. The students learn the importance of aseptic techniques, and apply this knowledge in our hands-on laboratories.<\/p>\n<section class=\"cl-wrapper cl-panel-wrapper\"><div class=\"cl-panel reverse  \"><figure><img decoding=\"async\" src=\"https:\/\/web.uri.edu\/wp-content\/uploads\/sites\/1340\/IMG_1183-1-scaled.jpg\" srcset=\"\" alt=\"IMG_1183 (1)\"><\/figure><article><h1>Objectives<\/h1><p><\/p>\n<ul>\n<li>Attain knowledge and achieve proficiency in both upstream and downstream biopharmaceutical manufacturing.<\/li>\n<li>We begin with the theories that built the biopharmaceutical industry then move straight into the methodologies and principles that underlie the processes of mammalian cell culture and aseptic upstream operations.<\/li>\n<li>Perform hands-on techniques for growing and maintaining anchorage dependent and suspension cell lines.<\/li>\n<li>Understand critical parameters involved in aseptic mammalian cell culture within various cell culture vessels including 2 L bioreactors.<\/li>\n<li>Understand and integrate cell culture methodologies and techniques with performance indicators in order to optimize individual proficiencies.<\/li>\n<\/ul>\n<p><\/p><\/article><\/div><\/section>\n<h1>Who should attend this course?<\/h1>\n<p>Course work and laboratory exercises are designed for individuals working in the Biomanufacturing industry including roles such as Upstream and Downstream Technicians, Quality Assurance, Quality Control, Bioprocess Engineers, Facilities and Plant Operations<\/p>\n<section class=\"cl-wrapper cl-panel-wrapper\"><div class=\"cl-panel  \"><figure><img decoding=\"async\" src=\"https:\/\/web.uri.edu\/wp-content\/uploads\/sites\/1340\/customtraining4.png\" srcset=\"\" alt=\"customtraining4\"><\/figure><article><h1>Delivery<\/h1><p>In-person lectures and hands on activities in a simulated GMP facility.<\/p>\n<ul>\n<li>Duration: 3 Days<\/li>\n<li>Time: 8:00am to 4:00pm<\/li>\n<li>Location: Kingston, RI<\/li>\n<li>Max Number of Participants: 15<\/li>\n<\/ul>\n<p><\/p><\/article><\/div><\/section>\n<h1>Instructors<\/h1>\n<\/p>\n<div class=\"uri-people-tool cl-tiles halves\"><div class=\"peopleitem h-card has-thumbnail\">\n\t<header>\n\t\t<div class=\"header\">\n\t\t\t\t\t\t<figure>\n\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/web.uri.edu\/pdi\/meet\/malcolm-g-pluskal-ph-d\/\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"500\" src=\"https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/Malcolm-Pluskal.jpg\" class=\"u-photo  wp-post-image\" alt=\"Dr. Malcolm Pluskal, University of Rhode Island School of Pharmacy\" srcset=\"https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/Malcolm-Pluskal.jpg 500w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/Malcolm-Pluskal-300x300.jpg 300w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/Malcolm-Pluskal-150x150.jpg 150w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/Malcolm-Pluskal-364x364.jpg 364w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" \/><\/a>\n\t\t\t\t\t\t\t<\/figure>\n\t\t\t\n\t\t\t\t\t\t\t<h3 class=\"p-name\"><a href=\"https:\/\/web.uri.edu\/pdi\/meet\/malcolm-g-pluskal-ph-d\/\">Malcolm G Pluskal, Ph.D.<\/a><\/h3>\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t<\/header>\n\t<div class=\"inside\">\n\n\t\t<p class=\"people-title p-job-title\">Instructor, Purification<\/p>\n\t\t\n\t\t\t\t<p class=\"people-department\"><\/p>\n\t\t\n\t\t\n\t\t\n\t\t<div style=\"clear:both;\"><\/div>\n\t<\/div>\n<\/div>\n<\/div>\n<p>\n<hr>\n<h1>Content Outline<\/h1>\n<h2>Lectures<\/h2>\n<h2>Day 1<\/h2>\n<ol>\n<li>Trends in the industry<\/li>\n<li>Creation of a genetically engineered cell line\n<ul>\n<li>Chinese Hamster Ovary cells to produce therapeutic antibodies<\/li>\n<\/ul>\n<\/li>\n<li>Cell banking operations<\/li>\n<li>Regulatory and clinical trials<\/li>\n<li>Utilities<\/li>\n<li>Overview of biomanufacturing processes: upstream\n<ul>\n<li>Clean room gowning<\/li>\n<li>Cell inoculum<\/li>\n<li>Cell scale up\n<ul>\n<li>Benchtop bioreactors to single use systems<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li>Cell harvest and in-process release testing<\/li>\n<\/ol>\n<h2>Day 2<\/h2>\n<ol>\n<li>Protein Concentration and Purification<\/li>\n<li>Types of chromatography<\/li>\n<li>The mobile phase<\/li>\n<li>The stationary phase<\/li>\n<li>Resins<\/li>\n<li>Wash buffers<\/li>\n<li>Elution buffers<\/li>\n<\/ol>\n<h2>Day 3<\/h2>\n<ol>\n<li>Viral interaction and removal\n<ul>\n<li>Viral anatomy<\/li>\n<li>Viral reduction<\/li>\n<li>Viral inactivation and removal<\/li>\n<\/ul>\n<\/li>\n<li>Cleaning, sterilization, and environmental monitoring\n<ul>\n<li>Cleaning\n<ul>\n<li>Cleaning in place (CIP) and Skid<\/li>\n<li>Cleaning validation<\/li>\n<\/ul>\n<\/li>\n<li>Sterilization\n<ul>\n<li>Steam in place (SIP) and autoclave<\/li>\n<li>Other sterilization protocols<\/li>\n<li>Sterilization validation<\/li>\n<\/ul>\n<\/li>\n<li>Facility Cleaning<\/li>\n<li>Environmental monitoring\n<ul>\n<li>Common microbes and endotoxin<\/li>\n<li>Gram stain<\/li>\n<li>Nonviable particulates<\/li>\n<li>Viable particulates<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<h2>Lab Exercises<\/h2>\n<h2>Day 1<\/h2>\n<ol>\n<li>Aseptic Processing\n<ul>\n<li>Gowning<\/li>\n<li>CHO cell thaw and inoculation<\/li>\n<li>ISO 5 personnel monitoring<\/li>\n<li>Biosafety cabinet monitoring<\/li>\n<\/ul>\n<\/li>\n<li>Cell morphology, counting<\/li>\n<\/ol>\n<h2>Day 2<\/h2>\n<ol>\n<li>Anatomy of column chromatography<\/li>\n<li>Choosing the correct resin<\/li>\n<li>Column packing<\/li>\n<li>Column purification of proteins using fluorescently labeled tag<\/li>\n<\/ol>\n<h2>Day 3<\/h2>\n<ol>\n<li>Clean room monitoring\n<ul>\n<li>Gowning<\/li>\n<li>Viable air sampling<\/li>\n<li>Non-viable air sampling<\/li>\n<\/ul>\n<\/li>\n<li>Bioreactor parameter and measurements<\/li>\n<li>Importance of proper mixing of solutions<\/li>\n<li>Observations of cell inoculum results from Day 1\n<ul>\n<li>Morphology and viability<\/li>\n<\/ul>\n<\/li>\n<li>Observations of personnel and environmental monitoring results from Day 1<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; This course is designed for biopharmaceutical manufacturers to ensure employees achieve proficiencies in both upstream and downstream biopharmaceutical manufacturing. We begin with the foundational theories of biopharmaceutical processing, then move into the methodologies and principles of mammalian cell culture and aseptic upstream operations. Students learn hands-on techniques for growing and maintaining anchorage-dependent and suspension [&hellip;]<\/p>\n","protected":false},"author":639,"featured_media":0,"parent":2234,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-internal-landing.php","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-3266","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3266","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/users\/639"}],"replies":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/comments?post=3266"}],"version-history":[{"count":5,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3266\/revisions"}],"predecessor-version":[{"id":4564,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3266\/revisions\/4564"}],"up":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/2234"}],"wp:attachment":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/media?parent=3266"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}