BioProcess International – Boston, MA
The Bioprocess International BioTech Week Annual Meeting is the premier event for bioprocessing professionals. BPI 2025 is a premier gathering for professionals in the biopharmaceutical industry, focusing on the entire spectrum of bioprocessing. The event aims to foster innovation, efficiency, and collaboration in biologics development and manufacturing. Learn more about by visiting the conference website: https://informaconnect.com/bioprocessinternational/
Poster Session: Real-time Monitoring and Control of Bioprocess Ultrafiltration/Diafiltration via In-line HPTLS-NIR
In downstream bioprocessing, multi-attribute process analytical technology (PAT) tools have been utilized more frequently for maintaining precise control over ultrafiltration/diafiltration (UF/DF) processes. High Precision Tunable Laser Spectroscopy NIR (HPTLS-NIR) has emerged as a powerful tool for measurement of protein and excipient concentrations, and thus for monitoring and control of bioprocesses. HPTLS-NIR provides advantages such as high signal-to-noise ratio, rapid quantification, simple in-line and at-line implementations, and high signal specificity for each analyte of interest. These advantages of NIR overcome disadvantages seen in other multi-attribute PAT tools that are still limited by the high material and labor requirements of developing and validating statistical models.
An implementation of the Nirrin Atlas system was developed for in-line measurements. The at-line Atlas, which uses HPTLS-NIR spectroscopy for measurement, was utilized to develop and validate analyte-specific spectral libraries, which were then transferred to the in-line system to reduce development time. Previous validation was done to ensure no instrument dependence in the analyte-specific library spectra that were created and transferred.
Successful implementation of the HPTLS-NIR in-line approach is demonstrated here for UF/DF runs throughout a UF/DF optimization process. The run data demonstrated accurate and rapid quantification of protein concentrations and all excipient concentrations during the UF/DF operation.
By utilizing HPTLS-NIR for quantification, this method was able to reduce the development and implementation time of a PAT tool for UF/DF monitoring from months to under 3 hours. Overall, the HPTLS-NIR in-line spectroscopy data proved the ability of this tool for monitoring and control of the UF/DF step and enabling of process automation through data previously unavailable for in-line quantification.
You Say When and Where
Run at-line quantitative measurements on a wide range of analytes and get answers right when you need them. Atlas can be used across all unit operations to provide cost effective, actionable insights.
The Atlas™
Replace Assumptions With Real Data.It’s Time.
Atlas reveals issues before they become big problems, providing rapid, on-demand, at-line analysis throughout the bioprocess. Only 15 µL of sample gets you data for excipients, surfactants, high-concentration proteins and monoclonal antibodies simultaneously in 1 minute. This is data which previously would’ve taken weeks. With Atlas, it’s all about you. Run your samples at line and get answers right when you need them. No sample prep, no complex analysis, just data you can trust.
