#United States #Gates Foundation #Newark #Monoclonal Antibodies #NIIMBL

NIIMBL-Led Team Awarded $10.5 Million for mAb Manufacturing

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has made an impressive announcement this October. A collaborative team led by NIIMBL has been granted a significant $10.5 million in funding through the Gates Grand Challenges Program. The objective? To pioneer advancements in the manufacturing of low-cost monoclonal antibodies (mAbs), which are essential for treating a variety of diseases, including cancer and autoimmune disorders.

The funding will be utilized over the next three years to explore and implement innovative technologies aimed at significantly dropping the costs associated with mAb production. Hosting this initiative are key collaborators, including Sartorius, Rensselaer Polytechnic Institute, Enquyst Technologies, and the University of Delaware. Joining this formidable team are additional contributors from Penn State, Michigan Technological University, and University College London.

Kelvin Lee, the Director of NIIMBL Institute, expressed his enthusiasm, stating, _“We are excited by the opportunity to demonstrate that there are existing solutions developed by industry and academic partners that can significantly reduce cost of goods and accelerate timelines.”_ This sentiment reflects the positive impact this funding could have on the broader public, as it enables the development of solutions designed to lower the production cost of life-saving therapies.

MAbs are vital in the fight against numerous health issues, yet the complexities involved in their production—ranging from raw material expenses to regulatory compliance—have hindered their availability. Discovering ways to streamline manufacturing processes will play a pivotal role in making these treatments more affordable for the majority. The goal set by the Gates Grand Challenge is ambitious yet crucial: achieve a target of $10 per gram for mAb production.

Sartorius has been at the forefront of innovative manufacturing methods. Principal Scientist, Benham Partopour, emphasized that this project embraces the synergy of Sartorius-driven innovations with novel workflows, ultimately aiming to enhance patient access to critical therapies. _“This funding will help bring life-saving therapies to patients,”_ he noted.

Rensselaer Polytechnic Institute's Todd Przybycien also highlighted potential breakthroughs in purification processes that would be integral in achieving the desired cost-effectiveness. His team is focused on developing solutions to ensure the global need for mAbs is met sustainably.

In a similar vein, Jason Criscione, the founder and Chief Scientific Officer of Enquyst, expressed eagerness about scaling up their innovative processing technology. His enthusiasm reflects the project’s objective to disrupt the current limitations in mAb manufacturing and deliver significant cost savings.

This Grand Challenge has special significance, being named after Dr. Steve Hadley, a former Senior Program Officer at the Gates Foundation. Dr. Hadley was known for his commitment to making monoclonal antibody therapies affordable and accessible, which aligns perfectly with the mission of this project.

About NIIMBL

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership dedicated to promoting biopharmaceutical innovation. The institute plays a pivotal role in developing standards that enable more efficient and rapid manufacturing capabilities. Situated within the broader framework of Manufacturing USA®, NIIMBL is also supported significantly through collaborations with academic and industry partners, alongside its cooperative agreement with the National Institute of Standards and Technology (NIST).

As this collaboration embarks on its groundbreaking journey funded by the Gates Foundation, the optimism surrounding the outcomes is palpable. By addressing the cost barriers in mAb manufacturing, they aim to herald a new era in the accessibility of critical medical therapies, benefiting countless patients around the globe.