908 Devices Inc.

09/06/2024 | Press release | Distributed by Public on 09/06/2024 10:32

Exploring the Future of Analytical Technology: At line Amino Acid Analysis vs. Traditional LC MS

In the rapidly evolving field of bioprocessing, analytical technologies play a pivotal role in helping scientists improve product quality and optimize manufacturing processes. Traditional Liquid Chromatography-Mass Spectrometry (LC-MS) has long been a cornerstone in this domain, renowned for its robustness and precision. However, as the industry demands faster, more user-friendly solutions, emerging technologies like 908 Devices' REBEL Cell Culture Media Analyzer are gaining traction.

REBEL is a capillary electrophoresis-mass spectrometry (CE-MS)-based device that provides rapid, easy, and efficient amino acid and nutrient analysis of cell culture media. With REBEL's at-line analysis capabilities, process development scientists can assess over 30 media components in less than 10 minutes.

Scientists from the U.S. Federal Drug Administration (FDA) evaluated the performance of REBEL against traditional LC-MS methods in monitoring amino acid concentrations in CHO cell culture bioreactors. The findings, first published in a poster for an internal FDA symposium, noted that both methods produced comparable amino acid trends across different bioreactors, demonstrating REBEL's capability to deliver reliable data.

FDA scientists also noted REBEL's ease of use and fast analysis times. In contrast, traditional LC-MS often demands high technical expertise and an extensive time investment. Given REBEL's benefits and its similar quality of data as LC-MS methods, FDA scientists concluded that REBEL can quickly advance understanding of media analytes' impacts on critical quality attributes, and thus drug safety and efficacy. Therefore REBEL is more suited to implement process analytical technologies (PAT) for better control of cell culture.

If you're considering an upgrade to your analytical toolkit, the REBEL analyzer's simplicity, speed, and reliable data could greatly enhance your lab's efficiency and data quality.

References

  1. Evaluating Traditional Mass Spectrometry Against the New Generation of Emerging Analytical Technology | FDA Nicole Azer, Xin Bush, Casey Kohnhorst, Nicholas Trunfio, Erica Berilla, David Powers FDA/CDER/OPQ/OBP/DBRRII

Webinar Presented by BioPharm International

In an upcoming webinar on September 17th, Nicole Azer from the FDA will dive deeper into the agency's research on implementing efficient and simplified methods for cell culture media analysis, which ultimately will lead to faster and innovative processes in biomanufacturing.

Can't attend? Register and we will send you an on-demand copy of the webinar.

Nicole Azer, MEng
Scientist II,
FDA | CDER | OPQ | OPQR