Flu Vaccine Manufacturing NIR Spectroscopy Delivers 3 Proven Improvements
Researchers at North Carolina State University have demonstrated how near infrared spectroscopy could transform flu vaccine manufacturing NIR spectroscopy applications by making cell culture based vaccine production faster, more accurate, and more efficient. The study, led by John Sheppard, professor of bioprocessing science at NC State, used a NIR probe to measure influenza virus concentration in cells growing in a bioreactor in close to real time. According to the Mayo Clinic, influenza affects millions of people annually and vaccine production speed is critical to matching circulating strains each season.
Why Current Flu Vaccine Manufacturing Methods Fall Short
The majority of flu vaccine production still relies on poultry eggs, a method first developed in the 1940s. This approach has several significant limitations. The resulting vaccine cannot be used by patients with egg allergies. The lengthy production timeline increases the risk of viral mutations that can cause the final vaccine to mismatch the strains actually circulating among the public. Egg based manufacturing is also more susceptible to microbial contamination and cannot be scaled up quickly enough to respond to pandemic outbreaks.
Cell culture based manufacturing addresses many of these problems. It produces fewer mutations, reduces allergy concerns, and is easier to scale up. However, as Sheppard noted, the transition to cell culture is not without its own infrastructure and regulatory challenges, and measuring viral concentration during the manufacturing process has remained a persistent technical problem that flu vaccine manufacturing NIR spectroscopy could now help solve.
How NIR Spectroscopy Improves Viral Concentration Measurement
The standard method for measuring viral concentration in cell culture involves a complex process that can take an hour or more to complete. The flu vaccine manufacturing NIR spectroscopy approach uses a probe inserted into the bioreactor that delivers close to real time data on viral concentrations as the cells grow.
Before the researchers could validate the NIR technique, they encountered a foundational problem: the existing standard measurement method was so inaccurate it could not serve as a reliable benchmark. The team had to develop a new, significantly more labor intensive manual method with higher accuracy before they could meaningfully compare it to the NIR probe results.
3 Proven Improvements From Flu Vaccine Manufacturing NIR Spectroscopy
1. Faster and More Accurate Concentration Data
At most viral concentration levels, the flu vaccine manufacturing NIR spectroscopy approach was substantially more accurate than the traditional standard method and delivered results in close to real time rather than after an hour or more of processing. This speed advantage has direct implications for manufacturing decision making throughout the production cycle.
2. Better Harvest Timing and Feeding Strategy Optimization
Real time viral concentration data allows vaccine manufacturers to identify the optimal moment to harvest cells, which directly affects yield and potency. The flu vaccine manufacturing NIR spectroscopy system also enables manufacturers to develop more precise feeding strategies to optimize both cell growth and virus production, reducing waste and improving batch consistency.
3. Earlier Detection of Batch Problems and Automation Potential
Because the NIR probe delivers continuous concentration data, production problems within a batch can be identified and addressed much earlier than with the current approach. Sheppard also noted that the technology could allow portions of the manufacturing process to be partially automated, further improving efficiency and reducing human error in flu vaccine manufacturing NIR spectroscopy enabled facilities.
What Comes Next
The researchers describe this study as a proof of concept. The next step is incorporating additional datasets to refine the computational model that translates NIR spectroscopy readings into viral concentration numbers. Sheppard expressed interest in collaborating directly with vaccine manufacturers to fine tune the process for real world production environments.
As the industry continues transitioning away from egg based production, tools that make cell culture manufacturing more predictable and efficient will be essential to meeting both routine seasonal demand and pandemic response requirements.
FOMAT conducts Phase I through Phase IV clinical research across a national network of investigator sites throughout the United States. To learn more about active infectious disease and vaccine studies, visit our patient active studies page.