Tulane Undergraduate Bridges Science and Business in Breakthrough Biotherapeutics Research

While many undergraduates spend their college years focused solely on coursework, Tulane University student Sylvia Austin has taken on a role that blends cutting-edge scientific research with real-world market analysis, helping to advance a technology that could transform how pharmaceutical companies develop life-saving biologic drugs.

Austin, Class of 2027 at Tulane's School of Science and Engineering, is working with Professors Wayne F. Reed and Curtis W. Jarand on a novel cuvette-based device designed to solve some of the pharmaceutical industry's most persistent challenges: biologic aggregation and hydrolysis. 

The technology developed at Tulane represents a significant advancement in biotherapeutic formulation. Professors Reed and Jarand have created a device that uses a standard spectroscopic cuvette and can be directly inserted into existing analytical instrumentation such as static or dynamic light scattering, UV-VIS, or Fluorimetry. By integrating an external flow path with advanced analytical techniques, the system enables observation of aggregation and degradation, intermolecular interactions, and kinetics in real time across dynamic conditions. 

The elegance of the innovation lies in its compatibility with existing laboratory equipment. Rather than requiring pharmaceutical companies to invest in entirely new systems, the device enhances the functionality of pre-existing cuvette systems, making adoption more feasible and cost-effective.

Not only is the device flexible across use with different instrumentation, but it is applicable to a wide range of biologics. The group has utilized the device to work with modalities such as mRNA, lipid nanoparticles, viral capsids for gene therapy, GLP-1 drugs for obesity and weight loss, monoclonal antibodies, other proteins, and conjugate vaccines.

Biologic drugs face the common problem of instability, which can lead to aggregation and/ or hydrolysis. When these complex molecules clump together or break down, they can become ineffective or even dangerous. Traditional approaches are often limited to discrete sample testing and endpoint measurements.

"Aggregation and hydrolysis are a recurring challenge during the development and formulation of biologics," Austin explains. "It is advantageous to know not just if the biologic is aggregating or hydrolyzing, but at what point, rate, and origin."

The Tulane technology offers a solution. "Within one sweep, the cuvette-technology generates comprehensive formulation data on parameters of instability," Austin says. "By covering a wide range of excipient or biologic concentrations, the most stable conditions can be determined in order to best optimize the formulation."

The technology's potential has been validated through collaboration with Moderna, Bachem, Merck, Wuxi Biologics, Roche/ Spark Therapeutics, and beginning collaborations with Sanofi and Novartis. Direct support from these leading biotechnology companies clearly demonstrates the technology’s industry relevance.  

Recent research done in collaboration with Moderna was published in ACS Omega and highlights the cuvette technology’s application to mRNA therapeutic development. The cuvette technology with its integrated dialysis monitoring capability was used to analyze how various electrolytes and excipients at different concentrations affect mRNA behavior. " It was discovered that aggregation and hydrolysis are closely linked to the stability of mRNAs secondary structure, offering valuable insights for industry development. Optimizing secondary structure stabilizes mRNA against both aggregation and hydrolysis," Austin notes. This research represents not just academic achievement but practical advancement in an area of intense pharmaceutical interest, as companies race to develop new mRNA therapeutics beyond COVID-19 vaccines.

Austin's role in the project extends beyond traditional undergraduate research. "My role in supporting this work has primarily been through market research and customer discovery," she explains. "To understand the underlying unmet need and to get feedback on the technology, I interviewed scientists in the biopharma industry and academia."

These interviews with experts in analytical, process, formulation, and downstream development of biologics provided crucial insights. "Insights from these discussions helped to understand the industry value, customer profile, market size, and competitive landscape," Austin says. "This stage has been valuable in validating the technology, getting feedback, and prioritizing different applications moving forward."

Her work demonstrates the importance of combining scientific innovation with market understanding. "It's important to conduct customer discovery early on, to determine industry needs before investing more time and resources in the project," Austin emphasizes.

Austin's success reflects the broader infrastructure Tulane has built to support student entrepreneurs and researchers. "The Tulane Innovation Institute and NE-ICORP Spark program were very helpful in providing guidance for customer outreach and interviews," she notes.

"Their resources for analyzing customer profiles and business models were valuable as well. The program is a great way to kick start the customer discovery process and is highly recommended."

The university's commitment to interdisciplinary collaboration has created an environment where undergraduates can work alongside faculty and alumni mentors. "Our interdisciplinary team has made my experience very valuable," Austin reflects. "Professor Reed and Professor Jarand have been incredible mentors, guiding me through the foundations of their new technology, the complex biologic modalities it is designed to study, and the broader implications of their research findings."

She also credits Tulane alumni Alex Reed and Jay Manouchehri, who have experience leading the successful spin out of Fluence Analytics. "They have mentored me on commercialization strategy, customer discovery, and start-up operations," Austin says. "Working on our small, collaborative team has given me exposure to both the scientific and business sides of the project and allowed me to learn directly from experienced mentors."

Austin's enthusiasm for the technology's potential is grounded in its practical applications. "The cuvette-technology's strong potential value in development and formulation of biotherapeutics is most exciting," she says. "Biologics are often extremely sensitive to changes in formulation conditions, but the ability to generate comprehensive formulation data will enable precise development decisions."

The technology is particularly relevant for emerging therapeutic modalities. "In particular, the device can be used to better characterize and understand instability in newer, more complex biologic modalities such as mRNA and bi or tri specific antibodies," Austin explains. "Additionally, the technology has great applications to studying stability at high concentrations, which is better for patient use and is of current demand."

The experience has profoundly influenced Austin's professional trajectory. "This experience has further deepened my interest in a career in the biotechnology or pharmaceutical industries, and has inspired a new interest in entrepreneurial settings," she says. "I've realized the importance of translating research from the lab into feasible solutions on the market for greater impact."

Her journey exemplifies Tulane's mission to prepare students not just as researchers or business professionals, but as innovators who can bridge both worlds. By giving an undergraduate significant responsibility in market research and customer discovery, the university has demonstrated its commitment to hands-on, impactful learning experiences.

The project represents a model for how universities can contribute to industry advancement while providing transformative educational experiences for students. Tulane's combination of cutting-edge research, institutional support through the Innovation Institute, and mentorship from successful alumni creates a pipeline from laboratory discovery to market application.

For Austin, the opportunity to contribute meaningfully to both the scientific and commercial aspects of the project have been invaluable. Her work interviewing industry scientists, analyzing market needs, and helping to shape the technology's development priorities demonstrates that undergraduates can play substantive roles in translational research when given proper support and mentorship.

As pharmaceutical companies continue to develop increasingly complex biologic therapies, innovations like the cuvette-based technology, and students like Sylvia Austin who help bring them to market, will play crucial roles in accelerating drug development. 

For any academic or industry groups interested in the cuvette technology or collaboration opportunities please contact wreed@tulane.edu.

More information is available at: https://tulane.theopenscholar.com/biologicsspectroscopy