"The products we are developing will help change the way next-generation products are approached." - Dr. Jon A. Rowley, Founder and Chief Product Officer
Better lives through a healthy society and a strong economy is the vision behind the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The Institute, a public-private partnership launched in March 2017, recently announced an array of projects designed to advance biopharmaceutical manufacturing and workforce development in the United States. Biopharmaceuticals are important because they treat and prevent some of the most prevalent and debilitating diseases, including cancer, diabetes, autoimmune disorders, and infection.
The overarching initiative represents approximately $14 million worth of activity over 18 months and involves 24 unique NIIMBL member organizations, including Regenerative Medicine industry vanguard, RoosterBio, Inc. (RBI). RoosterBio is the privately held stem cell tools and technology company which engineered a first-in-class line of products to paradigm shift global Regenerative Medicine product development, radically shortening the research and manufacturing cycles for hMSC (human mesenchymal stem/stromal cell)-based therapeutic products, including cell & gene therapies, exosomes, and engineered tissues & organs.
RoosterBio is part of two NIIMBL selected projects for grant funding:
- Quantitative Trilineage Differentiation Assays for cGMP Cell Manufacturing of hMSCs
- Development of Course Modules for Certificates and Professional Master’s Degree Programs in Manufacturing Leadership for Excellence in Cell Manufacturing
RoosterBio is leading development of quantitative trilineage differentiation assays for stem cell manufacturing in collaboration with PBS Biotech and Tulane University. The study aims to establish a quantitative standard for evaluating hMSCs to serve as critical metrics for hMSC-based therapeutic cell manufacturing. Such uniform standards will make it easier for investigators to engage contract manufacturing and testing organizations while ensuring continuity under current Good Manufacturing Practices (cGMP). hMSCs are critical raw materials for many regenerative medicine products and they’re currently associated with more than 800 clinical trials in the US, illustrating a strong need for further standardization in the field.
Jon A. Rowley, PhD, Founder and Chief Product Officer of RoosterBio, says he expects hMSCs use to grow rapidly over the next 20 years – not reaching peak demand for well over 20 years. “Technology improves every day. MSCs are now easily integrated into so many applications.” He notes their use in cell therapy, cosmeceuticals, clean meat and tissue engineering, with an opportunity to simply plug into other technologies; analogous to the way that microchips revolutionized the consumer electronics industry. “The products we are developing will help change the way next-generation products are approached. Combination products incorporating gene editing, engineered tissue, MSCs and synthetic biology will rule the market with multiple products addressing everything from heart failure to cancer to custom made bioprinted bones.”
The other grant project, development of course modules, addresses an equally dire need for qualified personnel to support expected rapid growth in the biopharmaceutical industry. The work force development program will build and beta test ten course modules in gene therapy and cell-based biologics manufacturing. Courses are geared towards student trainees, teachers from two-year colleges, and current industry professionals. The program will assess needs and develop content for both distance and on-site learning. Trainees will gain technical knowledge, such as cell processing, viral transductions, cell preservation, large-scale cell culture, cGMP-skills, cell analytics, quality engineering concepts, and supply chain logistics. They will also hone essential professional skills, including best manufacturing practices, regulatory compliance, regulatory filing processes, IP management, revenue models, cultural sensitivity, and policy awareness.
Dr. Tabassum Ahsan, RoosterBio’s Director of Analytical, Product and Process Development, is part of the project team led by Georgia Tech and the University of Pennsylvania. The University of Georgia, Merck, Akron Biotechnology LLC, and Unum Therapeutics are also contributing partners. She says participation is an opportunity to shape the future. “These courses could form the basis of new certificate programs and professional master’s degrees at universities across the nation, maintaining US competitiveness in Regenerative Medicine manufacturing.”
NIIMBL Institute Director Kelvin Lee says, “These projects are significant milestones for the Institute. We appreciate the interest and enthusiasm with which our early members approached the proposal process and look forward to the transformative technologies and critical training solutions these projects promise to bring to the industry and learning institutions.”
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership with the goal of advancing innovation in biopharmaceutical manufacturing. NIIMBL is part of Manufacturing USA™, a network of manufacturing innovation institutes across the country that bring together industry, academia, and the public sector to propel early-stage research, accelerate new products to market, and train tomorrow’s workforce in order to secure America’s future. NIIMBL is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and leverages additional support from industry, academic institutions, non-profit organizations, and the states of Delaware, Maryland, North Carolina, and the Commonwealth of Massachusetts. The NIIMBL mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.
RoosterBio, Inc. is a privately held stem cell tools and technology company focused on accelerating the development of a sustainable Regenerative Medicine industry, one customer at a time. RoosterBio’s products are high volume, affordable, and well-characterized adult hMSCs paired with highly engineered bioprocess media systems. RoosterBio has simplified and standardized how stem cells are purchased, expanded, and used in development, leading to marked time and costs savings for customers. RoosterBio’s innovative products are ushering in a new era of productivity and standardization into the field, accelerating the road to discovery in Regenerative Medicine. For more information on RoosterBio and adult stem cells, please visit http://www.roosterbio.com, follow on twitter (@RoosterBio), or read the blog “Democratizing Cell Technologies” (http://www.roosterbio.blogspot.com).