Modeling the Future of Biopharmaceutical Manufacturing
Over the past year, as we have watched the numbers of COVID-19 cases skyrocket here in the United States and around the world, the importance of bringing a safe and effective vaccine to market as quickly as possible has become abundantly clear. But this is just one example of the urgency a burgeoning industry faces in seeking to address cancer, sickle cell anemia, Parkinson’s disease, and a multitude of other ailments.
Massive strides in biological research have come, in part, from the use of advanced data analytics, moving us closer day by day to the commercialization and manufacture of promising new medicines and therapies. Trends indicate that a digital transformation in the bioprocessing and manufacture of these new discoveries is also in the offing, and improving the way scientists and engineers are trained for this revolution can hasten progress. “We are presented with a tremendous opportunity at this moment in time. By including data analytics and engineering as a part of workforce training programs, and equipping the current and emerging workforce with new skills, the potential gains in quality, productivity, cost-efficiency, and speed-to-market can be realized,” notes Prashanth Asuri, Santa Clara University Associate Professor of Bioengineering and Director of the BioInnovation and Design Lab.
To address this opportunity, Santa Clara University has partnered with Genentech to create the West Coast Biomanufacturing Consortium for Analytics and Data engineering (BioCAD). Funded by a $300,000 grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a primary goal of BioCAD is to upskill working engineers and scientists, enabling them to make data-informed manufacturing decisions.
Over the past several months, BioCAD piloted boot camps for Genentech employees and Santa Clara engineering students. Asuri (Primary Investigator on the grant) notes, “To meet the manufacturing challenges on the horizon, there needs to be a mindset change. Whereas data collection protocols have often been a matter of compliance, our goal is to get scientists and engineers excited about leveraging data and robust analytics tools to enhance outcomes. In these boot camps, we provide a ‘sandbox’ for them to play in to get more comfortable with analyzing data, making it palatable to move to a decision-making process that is more data-driven.”
“A data-driven approach is crucial due to the complexity and cost of bringing new therapies to market,” said Rita Wong, Senior Director, Head of Parental Launch and New Technologies, Hillsboro Technical Operations at Genentech, and co-Primary Investigator on the NIIMBL grant. “The complexity and cost of these biologics as well as the unique manufacturing requirements and patient markets for each therapy present significant engineering, business operations, and manufacturability challenges with many additional variables for consideration to automate biopharmaceutical manufacturing,” she explained.
New techniques such as robotics, miniaturization, automated control systems and others have streamlined bioprocesses, but choosing which methods to employ comes with a myriad of decisions as engineers weigh trade-offs surrounding cost, quality, deployment speed and flexibility in adapting to rapidly evolving advancements in technology. Inspired by the curriculum taught in the Department of Bioengineering, SCU faculty used an interdisciplinary approach to expose the boot camp attendees to how bioprocessing data can be utilized to develop reliable decision-making models. The content also provided context for applying data engineering techniques to manage and optimize biomanufacturing operations.
Attendees found the interdisciplinary approach especially beneficial, “as success demands implementation of multifunctional teams across scientific, chemical engineering, bioprocessing, and business operations,” Wong reports. In a follow-up survey, students said they appreciated learning alongside industry representatives and also the way the content was tied to practical applications. “I was engaged throughout the workshop because I felt as though I was learning something that I could bring with me in my career,” said one. Industry attendees noted the bootcamps provided a “good exchange between theory and coding,” and they appreciated the “blend of science, statistics and python modeling.”
Beyond bootcamps that seek to broaden our local engineers’ knowledge and skills, plans are in the works to develop learning modules that can be shared more broadly. To that end, Wong and Asuri have engaged three West Coast life science associations, Biocom Institute (in California), Life Science Washington, and Oregon Bioscience Association to guide content development and dissemination of biomanufacturing data analytics cases and companion datasets to employees of mid-sized companies on the West Coast. Eventually, national and international audiences will benefit through online learning modules.
The long-term vision is to build toward an industry-academic consortium that supports multiple training and education needs related to data analytics across West Coast biopharmaceutical manufacturing hubs and around the world. In the near-term, plans are afoot to pilot a collaborative summer institute here at Santa Clara in 2022 to offer in-depth applied learning opportunities for undergraduate and graduate students from traditionally underrepresented socioeconomic backgrounds. “BioCAD offers a tremendous opportunity for academia to engage with industry while serving our students and community stakeholders”, said Asuri. “It’s a win-win-win situation, and I am so grateful for Genentech’s partnership in making it happen.”