Go with the Flow Expert Panel Discussion | Hosted by Tony Hunt CEO - Repligen Corporation (06/29/21)
... to evaluate the flow BP technology maybe start with Ral yeah thanks Tony for for that question I think um when we were lookingΒ ...
Executive Chair, Repligen
Search every verified Anthony Hunt interview, podcast appearance, and on-the-record quote β each transcript cross-checked by AI and human review to confirm speaker identity. Anthony Hunt, Executive Chair at Repligen, hosted a "Go with the Flow" expert panel discussion on June 29, 2021. During the event, Hunt described Repligen as "very much committed" to process analytical technology (PAT) and said the company views inline monitoring as "the new wave." He stated that the business case for PAT tools involves both tangible benefits, such as lead time reduction, and less tangible benefits like additional process understanding. Hunt identified risk aversion as the biggest barrier to adoption of PAT technologies, noting that companies see introducing new technology as adding risk and potentially delaying timelines. Hunt also discussed challenges in implementing PAT, including the need for fully validated analytical methods and convincing health authorities that the tools are equivalent or better than current control strategies. He said that continuous manufacturing for downstream processes would not be possible without inline real-time monitoring, and that digital twins require real-time data from online PAT tools. Hunt noted that collecting more data can expose process inconsistencies, but said regulatory authorities want transparency and that high-quality data can help demonstrate process control.
“The business case question always comes back, and I think it's a mix. On the one hand, you do have tangible benefitβyou can calculate the return on investment for Flow VP. If you don't pull the sample anymore and get lead time reduction or no person in the QC lab coming in at night, that's a positive. But we also try t...”
“If you are really using this tool in a GMP process to make decisions, you need to be 100% sure the data is correct. Analytical methods must be fully validated, data integration must be spotless, and quality assurance must maintain the instrument properly. You also need to convince health authorities that this tool is e...”
“The biggest barrier to adoption of PAT technologies is risk aversion. If a process has worked so far, companies see introducing new technology as adding risk and potentially delaying timelines. Also, manufacturing groups are cautious about adding equipment that could compromise sterility, and there is ambiguity about w...”
“Continuous manufacturing is on the cusp of being feasible for downstream processes like ultrafiltration/diafiltration, but it would not be possible without inline real-time monitoring such as Flow VPX. This technology can reduce lead times and enable automated process control.”
“The focus of our PAT strategy was to get better process understanding and handle variability inherent in any process. By applying Flow VP or other PAT instruments with control algorithms, we can ensure consistent performance and mitigate risks of underloading or overloading resins.”
“In tech transfer, having online tools like Flow VPX is critical because it provides real-time data that can reduce the need for extensive engineering runs or development work at scale. For example, monitoring mixing times or protein concentration can accelerate process understanding and transfer between sites.”
“Digital twins are becoming more routinely used, but a critical prerequisite is having real-time data from online PAT tools like Flow VPX. Offline sampling and QC lab experiments are insufficient to build accurate digital twins for process modeling.”
“The amount of data collected every 10 seconds with Flow VPX compared to traditional QC sampling opens new possibilities for process control and problem solving. It broadens the horizon of what can be done with inline monitoring technologies.”
“One of the biggest challenges is the fear of data. People worry that collecting more data will expose process inconsistencies and lead to investigations. But regulatory authorities want transparency, and high-quality data from PAT tools can help demonstrate process control rather than hide issues.”
“Implementing Flow VPX or any PAT tool requires a dedicated team because there will be challenges and pushback from regulatory and quality groups. Having people committed to change and improvement is crucial for successful implementation.”
... to evaluate the flow BP technology maybe start with Ral yeah thanks Tony for for that question I think um when we were lookingΒ ...
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