The U.S. Dept. of Defense (DOD) selected Seattle-based Just – Evotec Biologics to develop an accelerated monoclonal antibody development and manufacturing solution for the DOD’s manufacturing optimization program. The multi-year program award, valued up to $39 million, will support the U.S. Government’s effort to enhance its rapid response capabilities for biologics medical countermeasures (MCMs), according to the DOD.

Just – Evotec Biologics will focus on project activities and technologies designed to 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 criterion, said Matthias Evers, PhD, CBO of Evotec.

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.

Emergency response system 

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, added Linda Zuckerman, PhD, executive vice president, global head of therapeutics, Just – Evotec Biologics.

“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,” she continued.

“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,” noted Bruce Goodwin, joint project lead at JPEO-CBRND (JPL for CBRND Enabling Biotechnologies).

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