Anthony Hunt on GMP
From Go with the Flow Expert Panel Discussion | Hosted by Tony Hunt CEO - Repligen Corporation (06/29/21) · · Repligen
“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 equivalent or better than current control strategies.”
On , Anthony Hunt, Executive Chair at REPLIGEN CORP, spoke about GMP during Go with the Flow Expert Panel Discussion | Hosted by Tony Hunt CEO - Repligen Corporation (06/29/21) on Repligen.
About Anthony Hunt
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.