About the series
Process Analytical Technology (PAT) is intended to support innovation and efficiency in biological therapeutics development, manufacturing, and quality assurance. Conventional biologic manufacturing is generally accomplished using batch processing with laboratory testing conducted on collected samples to evaluate quality, reducing overall efficiency of a process. In-line or near-line measurements of product purity are particularly important to improve efficiencies, reduce risk and improve product quality. The application of variable pathlength (VP) UV spectroscopy allows for concentration measurements in an extended dynamic range. Join us to learn from the experts that have successfully implemented variable pathlength technology into their PAT strategies.
June 1st 8am PDT | 11am EDT | 4pm GMT
Available On Demand Now
Application of Variable Pathlength Technology for Rapid Determination of Dynamic Binding Capacity
Rashmi Bhangale, Ph.D.
Downstream Process Development Scientist
KBI Biopharma
An ever-increasing demand for biomolecule-based therapies is driving biopharmaceutical companies to accelerate process development activities to remain competitive in today’s industry. Within the downstream process development space, affinity chromatography is widely used for primary capture of monoclonal antibodies, Fc fusion proteins, etc. Optimization of this step requires determination of dynamic binding capacity (DBC) for target protein molecule and can be a lengthy process using traditional methods. KBI Biopharma has applied the use of variable pathlength technology for rapid generation of breakthrough curves and determination of DBC for capture resin selection. FlowVPE, a variable pathlength UV detector from C Technologies, is integrated with the chromatographic system for real time generation of breakthrough curves, reducing the time and cost associated with the development of the primary capture step. This technology helps accelerate the overall process development timeline. Case studies are included.
About the speaker
Rashmi received her Ph.D. in Chemical Engineering from the Institute of Chemical Technology in Mumbai, India. Her research work focused on understanding the mechanisms involved in chromatographic separations for a priori prediction of purification performance. Rashmi joined the Downstream Process Development team at KBI Biopharma in North Carolina in 2018. She is involved in the development and transfer of purification processes for a variety of molecules including monoclonal antibodies, Fc fusions, and enzymes.
June 8th 8am PDT | 11am EDT | 4pm GMT
Available On Demand Now
CTech FlowVPE System in combination with MALS for Real Time Molecular Weight (RT-MW) Applications
Andres Martinez
Post-doctoral Scientist, Downstream Processing & Real-time Monitoring
Roche
Antibody fragmentation and aggregation result in the formation of product-related impurities with the potential of immunogenicity, loss of biological activity and failure of internal and external regulatory standards. Conventional analytics rely on off-line HPLC, usually done well after the analyzed unit operation has ended and no process corrections can take place. Multi Angle Light Scattering (MALS) can provide the real time molecular weight (Mw) of a pure solute or the average Mw of a solute matrix if the total concentration of the species is also available in real time. Analytical experiments with low protein concentration can use conventional fixed path length UV sensors, however these become saturated at the higher concentrations of manufacturing processes. The FlowVPE System enables the real time measurement of protein content in a wide concentration range, which can be coupled to MALS for RT-MW measurements. Besides a more agile process development, RT-MW can enable adaptive processing decisions and inform on product deviations.
About the speaker
Andres Martinez is part of the expert team that implements and manages Roche’s downstream processes and real-time monitoring to ensure the most efficient process possible. Andres received his Ph.D. from the Institute of Biochemical Engineering, Technical University of Munich in Germany. He also holds a Master of Science in Food Technology and Biotechnology from TU Munich. His foundational education earned him a Bachler of Science in Chemical Engineering from the Universidad Pontificia Bolivariana, Medillin in Columbia and from Münster University of applied Sciences, Germany. With such a comprehensive background, he’s now contributing with a pioneering team of bioprocess experts to drive maximum efficiency into the Roche downstream process.
June 15th 8am PDT | 11am EDT | 4pm GMT
Evaluating the new CTech FlowVPX System for UF/DF-Protein Concentration
Jay West
Principal Scientist
Bristol Myers Squibb
An evaluation of a beta version of the FlowVPX and Viper software was performed to determine it’s potential as an inline instrument for product concentration measurement during UF/DF operation, particularly high concentration UF/DF processes that are required for subcutaneous injection formulations (>150 g/L). The FlowVPX has significant potential for GMP and commercial biologics manufacturing unlike the first generation FlowVPE, which was designed as a lab scale instrument. Extensive testing was done using small and pilot scale UF/DF operations with several biologic drugs molecules from the portfolio. The FlowVPX instrument demonstrated very good comparability with other A280 based protein concentration measurements for all molecules tested (six). From a technical standpoint the FlowVPX is a GMP ready instrument, and further testing for instrument robustness and software development is ongoing at present to potentially use the instrument in the GMP space within the near future.
About the speaker
Jay West is Principal Scientist at Bristol Myers Squibb in the Process Development Analytics group in Devens, MA. He obtained his BS in Chemistry from Rensselaer, MS in Chemistry from University at Albany, PhD in Biochemistry from Boston College, and performed postdoctoral research at Northeastern University. He has 10 years pharmaceutical industry experience, working at Regeneron Pharmaceuticals in clinical manufacturing before starting a PhD, and joining BMS in 2014 as an analytical scientist. His focus the past four years has been on Process Analytical Technology, focusing on applications for downstream biologics process development.
June 22nd 8am PDT | 11am EDT | 4pm GMT
Drug Product/Protein Concentration using the CTech FlowVPE System
Raf De Dier
Associate Director for Innovation
in the Clinical Supply Chain
Janssen Pharmaceuticals
Protein concentration is one of the critical quality attributes of fill-finished drug products, as it ultimately defines the dosage a patient receives. Process analytical tools are key in monitoring this attribute and are used to control the manufacturing process accordingly. This presentation will give an overview of the journey from initial laboratory feasibility tests of the FlowVPE technology to implementation into an aseptic GMP facility for in-process control testing of biologics. In addition, the talk will highlight how the online technology sheds new light on the manufacturing process and increases product understanding. Building on the availability of real-time continuous protein concentration data, next steps in the development and implementation of a future automated human-free process execution will be shared.
About the speaker
Raf De Dier holds a Master’s degree in Chemical Engineering and obtained his PhD at the University of Leuven in Belgium and ETH Zürich in Switzerland. He joined Janssen R&D in 2016, where he was responsible for the process development and tech transfer support for liquid and lyophilized drug products in the parenteral fill-finish pilot plant. As part of the Manufacturing Science & Technology group, he lead various cross-functional PAT and process improvement projects. Currently, as the Associate Director Advanced Technology, he drives the proof-of-concept evaluation and implementation of new scientific initiatives across the clinical drug substance and drug product manufacturing sites of Janssen R&D.
June 29th 8am PDT | 11am EDT | 4pm GMT
All Industry Panel Discussion – Hosted by Tony Hunt, CEO - Repligen Corporation
Tony Hunt
CEO of Repligen Corporation
Repligen
Panel Discussion: Our panel with talk about the process to implementing and validating an in-line VPT system. They will discuss the planning methodology, the challenges they encountered and how they overcame them. They will also focus on the future of in-line testing, what is still missing? What are some exciting technologies on the horizon?
About the moderator
Tony J. Hunt was named President and CEO since May 2015. He joined Repligen in May 2014 as Chief Operating Officer, overseeing commercial and manufacturing operations. Before coming to Repligen, Mr. Hunt was President of Bioproduction at Life Technologies, a global life sciences company which was acquired by Thermo Fisher Scientific in 2014. He joined Life Technologies in 2008, serving as General Manager of Bioproduction Chromatography and Pharma Analytics before being named President of Bioproduction in 2011. From 2000 to 2008, Mr. Hunt was with Applied Biosystems as Senior Director of Pharma Programs where he launched the Pharma Analytics business that in 2008 became a part of the Bioproduction platform at Life Technologies. Mr. Hunt received a B.S. in Microbiology and an M.S. in Biotechnology from University College in Galway, Ireland, and an M.B.A. from Boston University School of Management.
Our panel
Rashmi Bhangale, Ph.D., Downstream Process Development Scientist – KBI Biopharma
Andres Martinez, Post-doctoral Scientist, Downstream Processing & Real-time Monitoring – Roche
Jay West, Principal Scientist – Bristol Myers Squibb
Raf De Dier, Associate Director for Innovation in the Clinical Supply Chain – Janssen Pharmaceuticals
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Please select webinars to register for:

  • Full Series (All 5 Webinars)
  • Application of Variable Pathlength Technology for Rapid Determination of Dynamic Binding Capacity

  • CTech FlowVPE System in combination with MALS for Real Time Molecular Weight (RT-MW) Applications

  • Evaluating the new CTech FlowVPX System for UF/DF-Protein Concentration

  • Drug Product/Protein Concentration using the CTech FlowVPE System

  • All Industry Panel Discussion – Hosted by Tony Hunt, CEO - Repligen Corporation

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