Enhancing the Future with Progressive Biomanufacturing

Over the past two decades, the biopharmaceutical industry has emerged as one of the major manufacturing industries and engines of growth in the US economy. Biomanufacturing represents nearly 2% of the total US GDP and its fraction is expanding. Much of biomanufacturing involves the use of cells to make medicines. Examples of these types of medicines include cancer medicines and vaccines. A key element in developing these medicines is the need to establish complex manufacturing processes. The Advanced Mammalian Biomanufacturing Innovation Center (AMBIC) will implement engineering innovations to enhance the capabilities of our nation to manufacture these important life-extending and life-saving medicines. Such improvements will improve the competitiveness of US biomanufacturing in coming decades leading to more economic investment by these companies and more jobs for American workers.

The mission of AMBIC is to develop enabling technologies, knowledge, design tools and methods that apply and integrate high-throughput and genome-based technologies to fast-track advanced biomanufacturing processes. AMBIC is the first I/UCRC dedicated to mammalian cell culture upstream development focusing on Chinese hamster ovary (CHO) cells, the principal biopharmaceutical production host of industry. AMBIC will bring together leading academic and industrial biotechnologists focused on mammalian cell culture manufacturing at a pre-competitive research level to address the complex problems in biopharmaceutical manufacturing. This multi-university center will allow AMBIC to leverage the skills and the expertise of many faculty members across the Sites. AMBIC will be a critical catalyst towards maintaining national excellence in biopharmaceutical production by conducting research in the following areas:

Understanding Industrially-Relevant Biology

Understanding Industrially-Relevant Biology

Research under this theme seeks to understand basic principles of relevant cell biology that address issues in the industry. Projects could include topics such as developing and improving -omic and metabolic models, identifying early markers for stability, understanding effects of raw materials on cells, biomarkers for cell behavior, epigenetic and ncRNA studies, identifying cell characteristics amenable to continuous processing, and identifying hotspots for target integration. This list is not exhaustive, but rather representative.

Process Monitoring and Control

Process Monitoring and Control

Research under this theme seeks to develop new analytical tools, sensors, and equipment, as well as approaches to integrate data from these devices, into improved methods for process monitoring and control. Projects could include topics such as in silico modeling for process integration, real-time -omics profiling, statistical process control, sensors for at-line, in-line, on-line product assays, measuring and controlling variability in raw materials, systems biology models for product quality predictions, predictive feed forward control models for critical quality attributes, and data mining tools for pattern recognition. Again, this list is intended only to be representative.

Consensus and Standardization Issues

Consensus and Standardization Issues

Research under this theme addresses important questions that new biological insights offer in the context of industry-wide impact where each company has unique products, processes, and platforms; yet has seen common issues impact multiple organizations or where organizations seek to develop industry-wide standards to facilitate regulatory compliance and best practices. Such projects could include work on: leachables and extractables, impurities, sustainability issues, performance standards for disposables, omics and clone characterization, demonstration projects for new technologies, standardizing the CHO genome, and building a better CHO.

Through systems-level biology analysis, novel cell line development, bioreactor optimization, and advanced analytics, AMBIC will provide transformative solutions that can lower biomanufacturing costs and improve bioprocessing efficiency. Most importantly, these advances may ultimately serve to make more biopharmaceuticals available to patients that need them and lower overall health care costs for consumers. In addition, AMBIC will establish and maintain a pipeline of educated and motivated students at multiple levels for careers in biopharmaceutical manufacturing and development. Collaborations with corporate partners will enable the students to work on the most pressing problems that the industry faces. Furthermore, this center will serve to engage and excite students from under-represented minority populations to pursue a career in life sciences, engineering, or related STEM fields. An important part of the AMBIC activities and a committed goal of the PI’s is to increase the participation of women and under-represented minorities in STEM disciplines by energizing students from all backgrounds about the exciting opportunities to help others through STEM careers in biotechnology and biomedicine.