A precipitation-based chromatography alternative, a novel viral vector isolation tech, and a glycosylation prediction system are among the projects awarded funding in the latest round of grants issued by U.S. manufacturing institute, NIIMBL.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced its new list of funding recipients in April, explaining it had selected projects that are most likely to help overcome common production hurdles.
A spokesman told GEN, “NIIMBL identifies major biomanufacturing challenges through extensive engagement with its large industry member companies, who provide the insights into their most critical and emerging needs. These collective inputs are systematically reviewed and prioritized to define the focus areas for subsequent project calls.”
Protein A alternative
For example, one project will see researchers at Rensselaer Polytechnic develop a precipitation-based alternative to Protein A chromatography. Replacing the widely used ligand, which costs $12,000 to $16,000 per liter, is seen as key to efforts to make mAb production cheaper.
Several of the selected projects are focused on analytics. For example, a team at Johns Hopkins is working on a system that can analyze mRNA payload distribution in lipid nanoparticles. Similarly, scientists at Purdue have partnered with Merck & Co. to use Raman and FTIR spectroscopy—as well as machine learning—to improve characterization in nanoparticle manufacturing.
Better analytics would aid biopharma, according to the NIIMBL spokesman, who said, “Real-time process analytical technologies represent a significant area of opportunity, offering the potential to improve efficiency, robustness, and quality assurance.
“Furthermore, as the industry advances toward more diverse and complex modalities, there is a critical need for platform-agnostic analytical tools and flexible manufacturing solutions that can support a broader range of products with enhanced reliability and scalability,” he continued.
Analytics is also central to a Carnegie Mellon University team’s effort to use machine learning to predict and control glycosylation in mAb production. The goal is to reduce experimentation time and enhance process efficiency.
Other analytics-focused projects include an effort to standardize adeno-associated virus (AAV) capsid isolation, which is being led by a team at North Carolina State University. The aim is to streamline process development, de-risk workflows, and enhance efficiency across multiple serotypes.
Cost reduction is another common theme. For example, researchers at the University of Massachusetts and the University of Pennsylvania have partnered with technology firm Sepragen to use continuous processing to make mRNA production cheaper.
Likewise, for its project, Pennsylvania-based VaxForm, will use adjuvants to improve the efficacy and stability of vaccine formulations, thereby minimizing raw materials costs.
Again, NIIMBL selected the projects based on industry need, according to the spokesman, citing mRNA production as an example.
“The maturation of mRNA technologies demonstrates that they are part of an important modality to address a range of therapeutic needs, including targets for the Global Health Fund, which is a partnership between the Gates Foundation and NIIMBL.
“However, the cost of reagents needed to produce this type of therapeutic can be a major contribution to the investment for their development and deployment. These new NIIMBL-supported projects will progress the ability of our community to manufacture and provide mRNA-based therapeutics,” he said.
NIIMBL also selected “workforce” projects to foster the development of training in areas where there is a skills shortage, such as AI.
The spokesman said, “With increased adoption of digital tools and AI in the industry, there is an increased need for talent coming from different disciplines and armed with many different skill sets, including data science, data analytics, computer programming, in addition to foundational skills in bioprocessing, cGMP, and molecular biology.
“This requires increasing awareness about the industry and careers among students and professionals coming from a wide variety of degree and non-degree-based pathways,” he said.
The post NIIMBL Awards Grants to Real-Time Analytics, mAb, and mRNA-Focused Projects appeared first on GEN - Genetic Engineering and Biotechnology News.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced its new list of funding recipients in April, explaining it had selected projects that are most likely to help overcome common production hurdles.
A spokesman told GEN, “NIIMBL identifies major biomanufacturing challenges through extensive engagement with its large industry member companies, who provide the insights into their most critical and emerging needs. These collective inputs are systematically reviewed and prioritized to define the focus areas for subsequent project calls.”
Protein A alternative
For example, one project will see researchers at Rensselaer Polytechnic develop a precipitation-based alternative to Protein A chromatography. Replacing the widely used ligand, which costs $12,000 to $16,000 per liter, is seen as key to efforts to make mAb production cheaper.
Several of the selected projects are focused on analytics. For example, a team at Johns Hopkins is working on a system that can analyze mRNA payload distribution in lipid nanoparticles. Similarly, scientists at Purdue have partnered with Merck & Co. to use Raman and FTIR spectroscopy—as well as machine learning—to improve characterization in nanoparticle manufacturing.
Better analytics would aid biopharma, according to the NIIMBL spokesman, who said, “Real-time process analytical technologies represent a significant area of opportunity, offering the potential to improve efficiency, robustness, and quality assurance.
“Furthermore, as the industry advances toward more diverse and complex modalities, there is a critical need for platform-agnostic analytical tools and flexible manufacturing solutions that can support a broader range of products with enhanced reliability and scalability,” he continued.
Analytics is also central to a Carnegie Mellon University team’s effort to use machine learning to predict and control glycosylation in mAb production. The goal is to reduce experimentation time and enhance process efficiency.
Other analytics-focused projects include an effort to standardize adeno-associated virus (AAV) capsid isolation, which is being led by a team at North Carolina State University. The aim is to streamline process development, de-risk workflows, and enhance efficiency across multiple serotypes.
COGS concerns
Cost reduction is another common theme. For example, researchers at the University of Massachusetts and the University of Pennsylvania have partnered with technology firm Sepragen to use continuous processing to make mRNA production cheaper.
Likewise, for its project, Pennsylvania-based VaxForm, will use adjuvants to improve the efficacy and stability of vaccine formulations, thereby minimizing raw materials costs.
Again, NIIMBL selected the projects based on industry need, according to the spokesman, citing mRNA production as an example.
“The maturation of mRNA technologies demonstrates that they are part of an important modality to address a range of therapeutic needs, including targets for the Global Health Fund, which is a partnership between the Gates Foundation and NIIMBL.
“However, the cost of reagents needed to produce this type of therapeutic can be a major contribution to the investment for their development and deployment. These new NIIMBL-supported projects will progress the ability of our community to manufacture and provide mRNA-based therapeutics,” he said.
AI training
NIIMBL also selected “workforce” projects to foster the development of training in areas where there is a skills shortage, such as AI.
The spokesman said, “With increased adoption of digital tools and AI in the industry, there is an increased need for talent coming from different disciplines and armed with many different skill sets, including data science, data analytics, computer programming, in addition to foundational skills in bioprocessing, cGMP, and molecular biology.
“This requires increasing awareness about the industry and careers among students and professionals coming from a wide variety of degree and non-degree-based pathways,” he said.
The post NIIMBL Awards Grants to Real-Time Analytics, mAb, and mRNA-Focused Projects appeared first on GEN - Genetic Engineering and Biotechnology News.