#United States #Newark #biotechnology #NIIMBL #mRNA Projects

NIIMBL Announces 11 New Projects in Biopharmaceutical Manufacturing

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has recently announced a significant initiative comprising 11 new projects aimed at advancing technology and workforce development in the biopharmaceutical sector. With a total value of around $11.2 million, these projects were unveiled as part of NIIMBL's Project Call 8.1, and they are designed to tackle pressing challenges faced by the biopharmaceutical industry while bolstering domestic manufacturing capabilities.

Focus Areas of the New Projects

Among the projects, six are centered on pivotal technology areas identified by NIIMBL’s member organizations. These include cutting-edge manufacturing platforms for biopharmaceuticals, innovative process analytical technologies, and advancements in data science and modeling. According to Sandeep Kedia, NIIMBL Senior Technology Fellow, these collaborative efforts are poised to enhance current manufacturing processes and analytical methodologies significantly. He expressed optimism regarding their potential, stating, “We are excited about the ability these projects have to advance our capability to manufacture biologic products and push the boundaries of what is achievable in biomanufacturing.”

In addition to technological improvements, the initiative includes three workforce-related projects focused on enhancing awareness and developing a talent pipeline. John Balchunas, NIIMBL's Workforce Director, emphasized the importance of innovative recruitment strategies to attract new talent to the biopharmaceutical sector. He believes that these initiatives will provide fresh tools to cultivate a skilled workforce necessary to meet the industry's future needs.

Global Health Fund Initiatives

Furthermore, the NIIMBL Global Health Fund (GHF), with funding contributions from the Gates Foundation, aims at developing and implementing breakthrough technologies for manufacturing pioneering medical countermeasures and biologics. Two of the new projects under this initiative focus on reducing the manufacturing costs of mRNA-based preventative medical solutions. Chris Roberts, Associate Institute Director at NIIMBL, noted the transformative potential of mRNA technologies, saying, “With mRNA technologies opening the doors for new therapeutics, we are excited by the opportunities these projects provide to lower costs.”

Project Breakdown

The list of new projects encompasses a variety of innovative research focuses:

• - Technology Projects:

- Automation and Control of Continuous Downstream Process led by Rensselaer Polytechnic Institute, involving major industry players like AstraZeneca and Merck.
- Rapid Bioburden and Sterility Testing led by Mango, Inc., targeting efficiency gains in biopharmaceutical manufacturing.
- Single Particle Analyzer for RNA Therapy led by Johns Hopkins University, in collaboration with key technology partners.
- Integrating Chromatography with Data Science led by North Carolina State University to optimize AAV capsid quantification.
- Combining Analytics with Machine Learning led by Carnegie Mellon University to enhance predictive capabilities.
- Spectro-acoustic Process Monitoring led by Purdue University, focusing on real-time biopharmaceutical analysis.

• - Workforce Projects:

- Creation of National Standards for Biomanufacturing Technician Apprenticeship led by Apprenti.
- Life Sciences Career Hub Biomanufacturing Project led by MassBio Education Foundation, aiming at career advancement in biomanufacturing.
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