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Just - Evotec Biologics Selected by U.S. Department of Defense for Manufacturing Optimization Program

Just - Evotec Biologics Selected by U.S. Department of Defense for Manufacturing Optimization Program

美國國防航空選擇依福泰克生物製品公司進行製造業-半導體優化計劃。
Accesswire ·  06/25 13:50
  • Just - Evotec Biologics will deliver an ultra-rapid, cost-efficient biotherapeutics manufacturing platform solution for the DOD's Manufacturing Optimization Program
  • Manufacturing solution includes seamless integration of accelerated mAb drug development into the overall Manufacturing Optimization Program
  • Manufacturing Optimization Program effort enhances U.S. Government's rapid response capabilities for biologics MCMs in response to emergency situations
  • Just - Evotec Biologics將爲DOD的製造優化計劃提供超快速、高效的生物治療製造平台解決方案,請使用您的moomoo帳號訪問該功能。
  • 製造解決方案包括將加速的mAb藥物開發無縫集成到整個製造優化計劃中。
  • 製造優化計劃的努力提高了美國政府在應對緊急情況下的生物醫學制劑的應對能力。

HAMBURGSUND, SWEDEN / ACCESSWIRE / June 25, 2024 / Evotec SE (Frankfurt Stock Exchange:EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ:EVO) today announced that its Seattle-based subsidiary, Just - Evotec Biologics, Inc., was selected by the U.S. Department of Defense ("DOD") to develop an accelerated monoclonal antibody ("mAb") development and manufacturing solution for the DOD's Manufacturing Optimization Program. The multi-year program award, valued up to $ 39 m, will support the U.S. Government's effort to enhance its rapid response capabilities for biologics medical countermeasures ("MCMs").

2024年6月25日,瑞典漢堡松德/ACCESSWIRE——Evotec SE(法蘭克福證券交易所:EVT;MDAX/TecDAX;ISIN:DE0005664809;納斯達克:EVO)今天宣佈,其位於西雅圖的子公司Just - Evotec Biologics,Inc.被美國國防部("DOD")選中,爲DOD的製造優化計劃開發快速的單克隆抗體("mAb")開發和製造解決方案。這個爲期多年的計劃獎項價值高達3.9億美元,將支持美國政府增強其對生物醫學制劑("MCMs")的快速應對能力。

Under the program, Just - Evotec Biologics will focus its expertise on project activities and technologies that will significantly decrease the time for development, manufacturing, and CMC-focused regulatory efforts. These innovations will significantly increase the speed to first clinical doses while maintaining high mAb quality, productivity, and safety criteria. Activities include developing and testing process development optimization, improving efficiencies in cGMP manufacturing and drug product release, and enhancing operational and resource workflows. The program will culminate in testing the optimized system components through rapid response exercises, starting with a DOD-identified MCM antibody sequence, and ending with the manufacturing of clinical doses.

在該計劃下,Just - Evotec Biologics將專注於項目活動和技術上,這些活動和技術將顯着縮短開發、製造和麪向CMC的監管工作的時間。這些創新將顯着增加首次臨床劑量的速度,同時保持高質量的mAb質量、生產率和安全標準。活動包括開發和測試過程開發優化、提高cGMP製造和藥物產品發佈的效率,以及增強操作和資源工作流程。該計劃將以快速反應演習測試優化的系統組件,從DOD確定的MCM抗體序列開始,以製備臨床用量結束。

The Just - Evotec Biologics' optimized manufacturing solution will seamlessly integrate into the U.S. Government's rapid emergency response system spanning the entire drug development lifecycle, with an overall 100-calendar day target timeline for advancing drug development from pathogen identification through fielding of doses.

Just - Evotec Biologics的優化製造解決方案將無縫集成到美國政府的緊急應急系統中,該系統涵蓋整個藥物開發生命週期,總體目標時間表是在100個日曆日內通過進展路徑覈查進行治療劑量的針對性分配。

Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just - Evotec Biologics stated: "We are proud to be selected to provide our expertise and technologies in support of this important program. We are excited to push our current end-to-end biologics development platform and partner with the DOD to bring 'next level' development of fast, high quality, cost efficient mAbs to the clinic."

Just - Evotec Biologics全球首席生物治療師Linda Zuckerman博士表示:“我們很自豪能夠被選中支持這個重要的計劃,並在合作中提供我們的專業知識和技術。我們很高興以合作爲基礎將我們當前的端到端生物治療平台推向‘下一級’,進行快速、高質量、高效的mAb臨床開發。

Dr Matthias Evers, Chief Business Officer of Evotec, commented: "It is an honor to further support and expand our work for the DOD with this program of strategic importance that could bring further innovation in mAb development and manufacturing to the industry. We strongly believe that by focusing on the design and application of innovative technologies we will dramatically expand global access to biotherapeutics."

Evotec首席商務官Matthias Evers博士評論道:“我們很榮幸通過這個具有戰略重要性的計劃繼續支持和擴大我們在DOD的工作。我們堅信,通過專注於創新技術的設計和應用,我們將極大地擴展全球對生物治療學的獲取能力。"

Mr. Bruce Goodwin, Joint Project Lead at JPEO-CBRND (JPL for CBRND Enabling Biotechnologies): "The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) is thrilled to reinforce its collaboration with Just - Evotec Biologics in the context of an innovative program. This strategic alliance enables us to harness the power of advancements in manufacturing as part of our readiness and agile reaction approach, ensuring that we are prepared to swiftly develop medical countermeasures in response to a diverse array of biologic threats."

JPEO-CBRND(CBRND Enabling Biotechnologies的聯合項目領導)聯合項目領導Bruce Goodwin先生表示:“化學、生物和核防禦聯合計劃行政辦公室(JPEO-CBRND)非常高興能夠在一個創新項目中加強與Just - Evotec Biologics的合作。這個戰略聯盟使我們能夠利用先進製造的力量,作爲我們的準備和敏捷反應方法的一部分,確保我們能夠迅速開發出響應各種生物威脅的醫學制備品。"

The contract was awarded to Just - Evotec Biologics by the DOD's Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), Joint Product Lead for Enabling Biotechnologies (JPL CBRND EB) under contract number MCDC2301-001.

Just - Evotec Biologics的合同是由美國國防部化學、生物、放射性和核防禦聯合計劃行政辦公室(JPEO-CBRND)生物技術(JPL CBRND EB)的聯合項目領導(JPL for CBRND Enabling Biotechnologies)授予的,合同編號爲MCDC2301-001。

Prior contracts awarded to Just - Evotec Biologics by the DOD include the COVID project, which enabled the manufacture of doses under tight timelines and restricted resourcing, and Accelerated Antibodies, which focuses on mAb prophylactic therapies for Plague and Orthopoxviruses.
About the Manufacturing Optimization Program
The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense requires innovative approaches that can accelerate the drug development lifecycle through production and delivery. Under this prototype project, the United States Government ("USG") is seeking optimized manufacturing platforms and techniques that can be seamlessly incorporated into an integrated emergency response system that covers the entire drug development lifecycle. Innovative manufacturing solutions will support an overall 100-calendar-day target timeline for advancing drug development from pathogen identification through fielding of doses. This is necessary, due to a dynamically changing chemical/bioweapons threat landscape and increasing potential that the war fighter may encounter unanticipated threats in the field. Further, drug development timelines are historically lengthy, limiting response capabilities in an emergency scenario. The primary objective of this effort is to identify, develop and demonstrate optimized manufacturing platforms/techniques that can enhance the USG's rapid response capabilities for biologics MCMs.

之前由DOD授予的Just - Evotec Biologics的合同包括COVID項目,該項目在緊張的時間表和受限制的資源下實現了劑量的製造;以及加速抗體項目,該項目專注於瘟疫和正痘病毒的mAb預防性治療。
製造優化計劃簡介
化學、生物和核防禦聯合計劃行政辦公室需要創新方法,可以通過生產和交付加速藥物的方法加速藥物開發的生命週期。在這個原型項目下,美國政府("USG")正在尋求可以無縫集成到覆蓋整個藥物開發生命週期的綜合緊急響應體系中的優化製造平台和技術。創新的製造解決方案將支持一個總共100個日曆日的目標時間表,以在從病原體識別到劑量投放的過程中推進藥物開發。由於化學/生物武器威脅形勢的動態變化以及作戰人員在戰場上可能遇到意外威脅的可能性越來越大,這是必要的。此外,藥物開發時間表歷來很長,限制了在緊急情況下的應對能力。這項工作的主要目標是確定、開發和演示優化的製造平台/技術,以增強美國政府對生物醫學制劑的快速應對能力。

About Just - Evotec Biologics
Just - Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform company that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just - Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at .

關於Just - Evotec Biologics
Just - Evotec Biologics是Evotec SE全資擁有的首個面向行業的生物製品平台公司,該公司利用人工智能/機器學習技術和世界領先的分子設計、細胞系開發、過程強化和連續製造策略,從發現到臨床階段再到商業推出推進生物治療。Just - Evotec Biologics團隊將數據、蛋白質、過程和製造科學等領域的豐富行業經驗與自動化相結合,具有高度集成和靈活性的能力,以突破與蛋白質治療相關的科學和經濟障礙。我們的重點是通過科學和技術創新加快並擴大對生物治療的獲取能力,針對我們的專有項目和代表我們的合作伙伴。更多信息,請訪問 .

About Evotec SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec provides high value pipeline co-creating partnerships and solutions to all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company's sites in Europe and the USA offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to and follow us on X/Twitter @Evotec and LinkedIn .

關於Evotec SE
Evotec是一家生命科學公司,擁有獨特的業務模式,實現其發現和開發高效治療方法並使患者受益的使命。公司的多模態平台包括一系列創新技術、數據和科學,用於發現、開發和生產一類和優秀的藥物產品。Evotec爲所有20大製藥公司和800多家生物技術公司、學術機構以及其他醫療保健利益相關者提供高價值的合作伙伴關係和解決方案。Evotec在一系列目前未得到充分服務的療法領域有戰略性活動,包括神經學、腫瘤學以及代謝和傳染性疾病。在這些專業領域內,Evotec旨在創建創新治療方法的世界領先的合作伙伴關係,並已經建立了一個由200多個獨有和合有的研發項目組成的組合,從早期發現到臨床開發。Evotec在全球擁有超過5000名高素質人才。該公司在歐洲和美國的網站提供高度協同的技術和服務,並作爲完善的卓越簇群運營。欲了解更多信息,請查看 並關注我們的X/Twitter @Evotec@Evotec領英(曾用名Twitter).

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec's securities. Words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "should," "target," "would" and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec's expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

前瞻性聲明
SOURCE: Evotec SE

For further information, please contact:

如需更多信息,請聯繫:

Media

媒體

Gabriele Hansen
SVP Head of Global Corporate Communications
Gabriele.Hansen@evotec.com

Gabriele Hansen
全球企業傳媒高級副總裁
Gabriele.Hansen@evotec.com

Hinnerk Rohwedder
Director of Global Corporate Communications
Hinnerk.Rohwedder@evotec.com

Hinnerk Rohwedder
全球企業傳媒董事
Hinnerk.Rohwedder@evotec.com

Investor Relations

投資者關係

Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com

Volker Braun
全球投資者關係與esg高級執行副總裁
Volker.Braun@evotec.com

SOURCE: Evotec SE

來源:Evotec SE


譯文內容由第三人軟體翻譯。


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