{"id":44470,"date":"2018-02-27T14:17:00","date_gmt":"2018-02-27T18:17:00","guid":{"rendered":"https:\/\/caireadydev1.wpenginepowered.com\/life-sciences\/cai-in-review-facilities-of-the-future-conference\/"},"modified":"2025-06-21T17:55:07","modified_gmt":"2025-06-21T21:55:07","slug":"in-review-facilities-of-the-future-conference","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/blog\/in-review-facilities-of-the-future-conference\/","title":{"rendered":"In Review: Facilities of the Future Conference"},"content":{"rendered":"<p><span style=\"font-size: 1.8rem;\">ISPE held its second Facilities of the Future conference.&nbsp; The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and regulators.&nbsp; Jim Breen, Vice President Lead Biologics Expansion, Janssen Pharmaceuticals, was the Program Planning Chair.&nbsp;&nbsp;<\/span><\/p>\n<p> <!--more--> <\/p>\n<p><img decoding=\"async\" src=\"https:\/\/cdn2.hubspot.net\/hubfs\/705173\/51174960_xxl.jpg\" alt=\"51174960_xxl\" width=\"6344\" style=\"width: 6344px;\"><\/p>\n<p>Most large companies have an internal group working on the idea of Facilities of the Future.&nbsp; The Global Pharmaceutical Manufacturing Leadership Forum (GPMLF), a group of senior pharmaceutical executives, has designated this subject, along with Developing the Workforce of the Future, as two of four key challenges facing industry.&nbsp; Both challenges were addressed by the many speakers during this two-day conference.<\/p>\n<p>&nbsp;<\/p>\n<p>Opening plenary speakers included Lawrence Yu, Ph.D., Deputy Director, Office of Pharmaceutical Quality and Leadership, US FDA; Antonio Moreira, Ph.D., Vice Provost for Academic Affairs, University of Maryland Baltimore Campus; Jay Douglass, COO, Advanced Robotics for Manufacturing Institute; Kent Mansfield, President, TruTag Technologies, Inc. &nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>Dr. Yu spoke about the FDA\u2019s initiative \u201cIntegrated Facilities Evaluation Inspection Program.\u201d&nbsp; This concept of operations combines chemists, engineers, and pharmacists in a team-based approach to regulatory approval of the facility and marketing application.&nbsp; This is designed to promote consistency, efficiency, and transparency, with improved timelines for decisions and enforcement actions.&nbsp; He described four types of inspections:<\/p>\n<ul>\n<li>Pre-approval<\/li>\n<li>Post-approval<\/li>\n<li>Surveillance<\/li>\n<li>For cause<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Results are communicated as either a \u201cNo Action Indicated\u201d letter (clean slate); \u201cVoluntary Action Indicated\u201d (a yellow warning); \u201cOfficial Action Indicated\u201d (serious). &nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>Dr. Yu also spoke about trends in continuous manufacturing and congratulated ISPE for promoting discussion on this subject.&nbsp; Three drugs have been approved:&nbsp; Vertex, J&amp;J, and Eli Lilly.&nbsp; He also mentioned a trend towards more robust process control strategy.&nbsp; Throughout the conference, the subject of continuous manufacturing was examined in detail, with presentations from J&amp;J, Eli Lilly, CONTINUUS Pharmaceuticals, and the FDA.&nbsp; The FDA has now approved the conversion of a batch process to continuous manufacturing. &nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>Juandria Williams, Ph.D., acting branch chief at the FDA, manages the CDER Emerging Technologies Task Team (CDER-ETT).&nbsp; To gain designation as an emerging technology, firms must submit a 5-page proposal to this group.&nbsp; The primary criteria are (1) novelty from pharmaceutical science; (2) advancement of product quality.&nbsp; The ETT has played a role in the approval of a 3D printed drug product, batch to continuous manufacture, and a breakthrough product manufactured using continuous processing.&nbsp; The FDA has identified continuous manufacturing as a breakthrough technology.<\/p>\n<p>&nbsp;<\/p>\n<p>Dr. Moreira spoke about the Workforce of the Future in the opening plenary, as did Dr. Robert Blouin, Provost, University of North Carolina at Chapel Hill in the closing plenary.&nbsp; There will be a global shortage of workers with skills needed to staff our manufacturing facilities.&nbsp; The universities must improve the academic experience to better prepare graduates for the demands of the facilities of the future.&nbsp; Lastly, Quality Executive Partners gave a presentation on the use of virtual reality for training aseptic operators and laboratory personnel.<\/p>\n<p>&nbsp;<\/p>\n<p>Many speakers offered new technologies, with other speakers discussing how to approach process control, scale up, real time release, and accelerated approvals.&nbsp; Robots were featured in new approaches to aseptic processing.&nbsp; Representatives from the BioPhorum Technology Working Group discussed their roadmap for the advancement of bioprocessing, and urged listeners to get involved in this group. &nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>The Facilities of the Future conference offered attendees exposure to a wide variety of subjects, all of which tied back to manufacturing life-saving products at lower cost, at higher levels of reliability, and significant advancements in manufacturing product quality.&nbsp; We look forward to the next production of similar content.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ISPE held its second Facilities of the Future conference.&nbsp; The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and regulators.&nbsp; Jim Breen, Vice President Lead Biologics Expansion, Janssen Pharmaceuticals, was the Program Planning Chair.&nbsp;&nbsp;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"resource-featured-status":[],"resource-type":[819],"class_list":["post-44470","post","type-post","status-publish","format-standard","hentry","category-uncategorized","resource-type-blog"],"acf":[],"featured_image_src":null,"featured_image_src_square":null,"author_info":{"display_name":"mikeviele","author_link":"https:\/\/caiready.com\/life-sciences\/blog\/author\/mikeviele\/"},"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/44470","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/comments?post=44470"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/44470\/revisions"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=44470"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=44470"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/tags?post=44470"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=44470"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=44470"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}