Purdue and Merck Develop Real-Time Raman Spectroscopy Tool for Vaccine Quality Control
核心洞察
Researchers at Purdue University and Merck have developed a patent-pending Raman spectroscopy-based tool that monitors vaccine quality in real-time during production, delivering results in 30 seconds or less.
The tool successfully detected human cytomegalovirus (搜索) particles at industrially relevant concentrations and flow rates, representing the first reported Raman spectroscopy system of this type for CMV detection.
Unlike current offline testing methods that require sample removal from production lines, this online monitoring system operates continuously during manufacturing, potentially saving time and money in vaccine production.
Researchers at Purdue University and Merck & Co. Inc. have developed a breakthrough analytical tool that uses Raman spectroscopy to monitor vaccine quality in real-time during production, addressing critical manufacturing challenges highlighted by the COVID-19 (搜索) pandemic. The patent-pending technology delivers quality control results in 30 seconds or less, representing a significant advancement over current offline testing methods.
Revolutionary Speed and Efficiency
The new tool operates directly on production lines, eliminating the need to remove samples for separate testing. "The current methods are more time-consuming and offline," said Shreya Athalye, a Purdue graduate student in agricultural and biological engineering. "Doing it online will save time and money in vaccine production."
Led by Mohit Verma, associate professor of agricultural and biological engineering at Purdue, the research team validated their system through tests that successfully measured the quality and quantity of continuously flowing viral particles. The study results were published in Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy.
Raman Spectroscopy Advantages
The researchers selected Raman spectroscopy as their foundation technology due to its unique properties for biological applications. The technique employs a laser to obtain a sample's molecular fingerprint and offers distinct advantages for vaccine monitoring. "It's nondestructive in nature, and its ability to work with samples that have water makes it ideal for biological samples such as vaccines," Athalye explained.
CMV Detection Breakthrough
The team demonstrated their tool's effectiveness by detecting particles of human cytomegalovirus (搜索) (CMV), a member of the herpes family. CMV primarily affects people with compromised immune systems, including transplant recipients, and presents significant vaccine development challenges. "CMV structure and mode of action make the vaccine development challenging, but many investigational vaccines are being evaluated in clinical trials," Athalye noted.
The research team reports being unaware of any previous Raman spectroscopy-based tool of this type for detecting CMV particles, marking this as a first-of-its-kind achievement in the field.
Industrial Application and Continuous Manufacturing
The system was tested under various flow rates, including industrial production conditions and static environments. "We wanted to make sure that we were developing a tool that can be transferred to industrial operating conditions," Athalye said. This validation specifically targets continuous manufacturing processes, where vaccines flow nonstop from production lines.
"Process analytical technology, or PAT, holds the potential to enable rapid release of biologics," Verma said. "By demonstrating that we're able to characterize CMV at industrially relevant concentrations and flow rates, we support easier adoption of this approach in biomanufacturing."
Building on Previous Research
This development builds upon the team's earlier work in applying Raman spectroscopy to biological systems. In 2022, Athalye co-authored a study from Verma's lab and that of Arezoo Ardekani, professor of mechanical engineering, that applied Raman spectroscopy and machine learning to measure viral particle concentrations in samples containing measles (搜索), mumps (搜索), and other viruses.
The current study advances beyond their 2020 research, which developed assays to detect bacterial and fungal contaminants under static conditions. "In this study, we are moving forward with a system that allows monitoring in continuous flow," Athalye said.
Future Applications and Environmental Benefits
The technology's flexibility allows for adaptation to other vaccine types beyond CMV. "Continuous manufacturing is the future. It is environmentally friendly, and it saves money and resources as well," Athalye said. "The critical component of continuous manufacturing is developing a robust quality-control tool, or more specifically, a process analytical tool."
Looking ahead, the research team plans to demonstrate Raman spectroscopy applications for other viruses, vaccines, and virus-like particles. "We will also be demonstrating the potential of probe-based methods in delivering such results so that they could be integrated into continuous manufacturing unit operations," Verma said.
The collaborative study combined expertise from multiple disciplines including agricultural and biological engineering, biomedical engineering, computer science, mechanical engineering, and materials science engineering. Merck co-authors provided samples and ensured compatibility with industrial operations, while the Purdue Innovates Office of Technology Commercialization has applied for patent protection of the intellectual property.