About

The Biopharmaceutical Manufacturing faculty cluster will lead universitywide, trans-disciplinary research and educational efforts related to the discovery, process development and manufacturing of next-generation biologics, including protein therapeutics, gene and cell therapies, nucleic acid-based products and vaccines. The objectives are: to enhance the university’s participation in large research efforts funded by federal agencies, nonprofits, industry and other academic institutions in the U.S. and worldwide; to develop new academic programs to educate and train undergraduate and graduate students in North Carolina and around the world on state-of-the art biopharmaceutical manufacturing technologies; and to identify opportunities for applications of these new technologies to other areas of biomanufacturing.

Major topics of interest to the cluster include, but are not limited to: 

1. Fundamental and applied molecular and cellular biology
   1. Cell engineering / synthetic biology (eukaryotes and prokaryotes) microbes, yeasts, filamentous fungi, plant sources
   2. Gene / cell therapy / extracellular vesicles / oligonucleotides / vaccines / antibodies / peptides
   3. Cell-free biologics manufacturing
2. Process science, technology and engineering
   1. Microbial and mammalian processes and scaling. Upstream and downstream operations – novel reactors, membranes, continuous processing, hybrid operations, scale-down models
   2. Process analytical technologies – in-line sensors, quality control, automation, on-time release 
   3. Robotics, machine design (personalized medicine), fill-finish, drug stability and drug delivery
3. Digitalization of biologics
   1. Artificial Intelligence / machine learning / digital learning
   2. Big Data analytics, Industry 4.0
   3. Bioprocess modeling, automation, digital twins, predictive models

Hires

It is anticipated that four to five new faculty members will be hired in the next two to three years. The first hire is:

Blake Rasor, Chemical and Biomolecular Engineering
Ph.D., chemical engineering, Northwestern University

Rasor’s research combines systems and synthetic biology approaches to engineer biocatalysis platforms. The goal is to convert light and carbon dioxide into sustainable chemicals ranging from fuels to pharmaceuticals, harnessing biology to utilize these abundant natural resources while minimizing environmental impacts. He joined the NC State faculty in the Department of Chemical and Biomolecular Engineering in 2025.

Other Cluster Faculty

Rodolphe Barrangou
Todd R. Klaenhammer Distinguished Professor of Food, Bioprocessing and Nutrition Sciences
College of Agriculture and Life Sciences

Ruben G. Carbonell
Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering
College of Engineering

Balaji Rao
Professor, Chemical and Biomolecular Engineering
College of Engineering

Other faculty from various colleges will be invited to participate soon.

Impact

The Biopharmaceutical Manufacturing faculty cluster will accelerate the development of sustainable and accessible manufacturing of biologics through advances in cell engineering and synthetic biology, and the development of novel process technologies and online analytical methods for upstream, downstream and fill-finish operations. These efforts will help revolutionize biopharmaceutical manufacturing to increase productivity, reduce costs and increase process flexibility while reducing its environmental footprint. Future good manufacturing practice (GMP) production of biologics will feature highly-intensified, continuous, or semi-continuous processes with in-line analysis and control enabled by novel sensors, digital twins and implementation of artificial intelligence (AI) and machine learning (ML) technologies.  Ideally, real-time batch release will be achieved by enabling online measurements of all critical quality attributes of the product, including contaminants and process- and product-related impurities. The costs associated with most biologics will be reduced significantly, making them more accessible to a worldwide population and enhancing the sustainability and security of the world’s supply chain for biologics.

History

The establishment of the Biopharmaceutical Manufacturing faculty cluster was approved by Executive Vice Chancellor and  Provost Warwick Arden in 2023, in recognition of the significant contributions made to the national biopharmaceutical manufacturing industry by the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at NC State, the rapid growth of this industry sector in the state of North Carolina, and the numerous opportunities for new research efforts that were made possible by the response to the COVID-19 pandemic.  BTEC played a key role in the creation of the National Institute for Innovation in Manufacturing Biopharmaceuticals, which is funded and managed by the National Institute for Standards and Technology. This has sparked new efforts to address the rapidly expanding technical needs of this industry in the future, which can only be successful through the collaborative efforts of experts from many different fields.