Go with the Flow II Expert Panel Discussion | Hosted by Ralf Kuriyel, Repligen (10/27/22)
... here at repen Ralph joined repen in 2016 as the senior VP of resch development where he oversees the company's R&D effortsΒ ...
Senior Vice President of Research & Development, Repligen
Search every verified Ralf Kuriyel interview, podcast appearance, and on-the-record quote β each transcript cross-checked by AI and human review to confirm speaker identity. Ralf Kuriyel, Senior Vice President of Research & Development at Repligen, hosted a panel discussion on October 27, 2022, as part of the "Go with the Flow II" expert webinar series. During the session, Kuriyel stated that Repligen is "passionate about pushing our automated systems marrying it with the proper PAT tools" with the goal of providing solutions that make manufacturing less expensive. He also noted that the company is "still in the research, in developmental stage" regarding further uses of flow VPX technology. The panel discussion covered topics including process analytical technology (PAT) and future perspectives on PAT in biologics manufacturing. Panelists discussed the use of inline flow VPX instruments for real-time monitoring of protein concentration during ultrafiltration/diafiltration processes. Challenges discussed included method transfers between groups, building trust in PAT for GMP manufacturing, and the need for stakeholder alignment and training when implementing new technologies.
“Our biologics, particularly the monoclonal antibodies, the drug substance concentration target was going from 50 to 150 grams per liter, which was a massive increase for subcutaneous injection, presenting significant manufacturing challenges without live inline concentration monitoring.”
“Using inline flow VPX instruments allows us to safely and consistently push drug substance concentration to the highest levels without risking critical quality attributes, which is critical for GMP manufacturing and process consistency.”
“The biggest driver for adopting flow VPX technology was saving hands-on time, reducing sample usage, and decreasing hold times for in-process control testing, which also supports shift work reduction and operational efficiency.”
“The key to getting flow VPX into GMP space is to use it initially for process monitoring while relying on traditional offline methods as the measurement of record, gradually building trust to allow full process control.”
“Flow VPX can play a huge role in moving towards digital twins and industry 4.0 by providing real-time insights into critical attributes like protein concentration, enabling objective process control and adaptive decision-making.”
“The pharmaceutical industry is behind other industries in digital infrastructure, but process analytical technologies like flow VPX are central to advancing automation and real-time quality control.”
“Real-time release is a multi-parameter challenge involving product quality, bioburden, and endotoxin testing; flow VPX is one technology that can shorten process times but other assays remain bottlenecks.”
“The pressure to adopt real-time release and advanced process control will come from pricing pressures due to biosimilars, the need for continuous manufacturing, and contract manufacturing organizations requiring rapid tech transfer.”
“Users of flow VPX must thoroughly understand the technology and validate accuracy and precision for their specific products and conditions to avoid poor quality data, especially at high protein concentrations.”
“The biggest challenge in implementing flow VPX is the complexity beyond analytical validation, including stakeholder alignment, cleanability, engineering, manufacturing, and training shop floor personnel.”
... here at repen Ralph joined repen in 2016 as the senior VP of resch development where he oversees the company's R&D effortsΒ ...
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