WuXi Biologics<\/a>\u2019 Drug Product Facility 15 (DP15), at WuXi\u2019s Fengxian site, Shanghai, achieved good manufacturing practice (GMP) release in April. The site now becomes the contract research, development and manufacturing organization (CRDMO)\u2019s 18th operational drug product facility worldwide.<\/p>\nSince achieving GMP release, WuXi Biologics says the facility has progressed seamlessly into operation, completing multiple engineering and GMP batches. These deliver clinical supplies to support clients\u2019 regulatory filings and clinical development needs.<\/p>\n
Designed for GMP Standards<\/p>\n
DP15, the company says, was specifically designed and built to meet international regulatory standards. It offers both flexibility and operational efficiency necessary for clinical-stage programs.<\/p>\n
Equipment at the facility includes advanced, isolator-based aseptic filling lines that enable both liquid and lyophilized drug product manufacturing. These lines also boast numerous advanced capabilities including 100% fill weight check, nitrogen overlay, and low-temperature loading for lyophilization.<\/p>\n
Additionally, fill\/finish solutions are provided for vial sizes from 2R to 20R.<\/p>\n
For client programs, WuXi Biologics says DP15 helps accelerate the transition from development to GMP manufacturing. This, according to the company, engenders faster and more efficient delivery.<\/p>\n
WuXi Biologics in Context<\/p>\n
Putting the latest regulatory development into perspective, Chris Chen, PhD, CEO of WuXi Biologics.<\/p>\n
\u201cThe successful GMP release of DP15 further strengthens our integrated delivery capabilities from drug substance to drug product,\u201d Chen said. \u201cWe will continue to enable clients to shorten technology transfer timelines, enhance execution efficiency, and advance key development milestones.\u201d<\/p>\n
Ultimately, Chen added, these initiatives will accelerate worldwide delivery of innovative biologics to patients.<\/p>\n
Shanghai and Beyond<\/p>\n
WuXi Biologics operates across China, the United States, Ireland, Germany, and Singapore. The CRDMO has five research centers, 10 development centers, and 18 manufacturing sites. Included among these are 24 drug substance facilities and, now with DP15, 18 drug product facilities in operation.<\/p>\n
The overarching goal of these facilities, WuXi<\/a> says, is to provide increasingly desired end-to-end integrated services and solutions for partners.<\/p>\n","protected":false},"excerpt":{"rendered":"Editor\u2019s Take: Pharmaceutical companies are increasingly seeking out CDMOs that can provide global, end-to-end services. WuXi Biologics\u2019 Drug…\n","protected":false},"author":2,"featured_media":668703,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[4,450,451,3,452,453],"class_list":["post-668702","post","type-post","status-publish","format-standard","has-post-thumbnail","category-breaking-news","tag-breaking-news","tag-breakingnews","tag-headlines","tag-news","tag-top-stories","tag-topstories"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/668702","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=668702"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/668702\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/668703"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=668702"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=668702"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=668702"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}