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Just – Evotec Biologics selected by US Department of Defence for Manufacturing Optimisation Programme

July 10, 2024 – BioManufacturing – US Government, biologics, contract, just – evotec

Just – Evotec Biologics will deliver an ultra-rapid, cost-efficient biotherapeutics manufacturing platform solution for the DOD’s manufacturing optimisation programme
Manufacturing solution includes seamless integration of accelerated mAb drug development into the overall manufacturing optimisation programme
Manufacturing optimisation programme effort enhances US Government’s rapid response capabilities for biologics MCMs in response to emergency situations

10 July 2024, Hamburg, Germany – 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 US Department of Defence (“DOD”) to develop an accelerated monoclonal antibody (“mAb”) development and manufacturing solution for the DOD’s manufacturing optimisation programme. The multi-year programme award, valued up to $39m, will support the US Government’s effort to enhance its rapid response capabilities for biologics medical countermeasures (“MCMs”).

Under the programme, 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 optimisation, improving efficiencies in cGMP manufacturing and drug product release, and enhancing operational and resource workflows. The programme will culminate in testing the optimised system components through rapid response exercises, starting with a DOD-identified MCM antibody sequence, and ending with the manufacturing of clinical doses.

Just – Evotec Biologics’ optimised manufacturing solution will seamlessly integrate into the US 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.

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 programme. 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.”

Dr Matthias Evers, chief business officer of Evotec, commented: “It is an honour to further support and expand our work for the DOD with this programme 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.”

Mr. Bruce Goodwin, joint project lead at JPEO-CBRND (JPL for CBRND enabling biotechnologies): “The joint programme executive office for chemical, biological, radiological and nuclear defence (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.”

The contract was awarded to Just – Evotec Biologics by the DOD’s joint programme executive office for chemical, biological, radiological, and nuclear defence (JPEO-CBRND), joint product lead for enabling biotechnologies (JPL CBRND EB) under contract number 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 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. Visit: www.just-evotecbiologics.com.