SUPPORT WEBINAR
Get Direct Support from a SoloVPE Specialist
Webinar Topics:
Optimize your SoloVPE for use
Understanding your data
Every week a different topic
Thursday @12:00PM EST
To learn more information contact us: support@ctechnologiesinc.com
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.
October 13th 8am PDT | 11am EDT | 5pm CEST
Available On Demand Now
Biologics concentration measurement using the in-line FlowVPX instrument during the UF/DF process in drug substance manufacturing
Jay West
Senior Principal Scientist
The FlowVPX System was used as an in-line instrument for product concentration measurement during UF/DF operations, with orthogonal offline testing done to check comparability. The FlowVPX device has generated significant interest for high concentration UF/DF processes in particular (>150 g/L) since overconcentration can result in precipitation. The FlowVPX System has significant potential for GMP and commercial biologics manufacturing with the development of single use flow cells by the vendor. Extensive testing was done using small and pilot scale UF/DF operations with several biologic drugs molecules from the company's portfolio. The FlowVPX instrument demonstrated acceptable comparability (within 5% difference) with orthogonal A280 based protein concentration measurements for all molecules tested. Accuracy and precision were equivalent for all flow cells and scales tested, suggesting the FlowVPX can be a robust reliable in-line instrument in GMP settings.
Jay West is Principal Scientist at Bristol Myers Squibb in the Process Development Analytics group in Devens, MA. Jay received his BS in Chemistry from Rensselaer, MS in Chemistry from University of Albany and worked at Regeneron Pharmaceuticals for 2.5 years. Jay received PhD in Biochemistry from Boston College and performed postdoctoral research at Northeastern University. He started at BMS in 2014 as an analytical scientist. His focus for the past five years has been on Process Analytical Technology, particularly on applications for downstream biologics process development.
Automation of biologics drug product manufacturing through modeling and FlowVPE
Renata Pocitarenco
Associate Scientist
Janssen Pharmaceuticals
Marius Mueller
Team Lead Analytical Fill-Finish Support
The presentation will focus on the development, testing, and justification of an advanced control strategy for automating the dilution process during the formulation step in fill-finish manufacturing. The proposed control strategy is founded on precise, accurate and fast protein concentration measurements, all provided by the FlowVPE technology. Being able to rely on timely, high-quality concentration measurements, the novel strategy combines the FlowVPE implemented on-line with real-time data processing and modelling, to achieve immediate feedback control of the dilution process without the need for human intervention. This approach was developed and tested in a lab-scale representative setup. In all performed tests, the automated process reached the target protein concentration with high accuracy and precision despite process variations and irregularities. The proposed automated dilution allows to increase productivity and offers a strategy with wide applicability.
Renata Pocitarenco is an Associate Scientist at Janssen, Switzerland. She received a B.Sc. and a M.Sc. in Chemical and Process Engineering from University of Padova, Italy, in 2019 and 2021 respectively, focusing on process systems engineering, chemometrics and statistical modeling. During her M.Sc. she spent 3 semesters abroad, doing an Erasmus at Otto Von Guericke Universität, Germany, an internship at Toyota Motor Europe, Belgium, and an internship at Janssen focusing on Machine Learning and simulations. She is passionate about mechanistic and data-driven modeling as tools to enhance and optimize pharmaceutical industrial processes.
Marius Müller is leading the analytical fill-finish support team at Janssen, Schaffhausen, Switzerland. His team is responsible for analytical study support as well as scouting, development and implementation of new PAT tools for drug product manufacturing. Marius joined Janssen as postdoc in 2018, establishing new analytical technologies for protein stability and aggregation. He holds a PhD in the field of mammalian synthetic biology and metabolic engineering from ETH Zürich in Switzerland. Prior he received his MSc degree in medical sciences from the University of Strasbourg in France as part of a tri-national study program.
Implementing PAT strategy using the FlowVPX System for in-line monitoring during batch/continuous chromatography.
Aishwarya Ramanan
Senior Research Associate
As Seagen steps into next-gen processing, continuous processing has been one of our major area of focus for 2022. With the increasing production demands, process intensification requirements are increasing as well. To meet this, in-line process analytical technology (PAT) can enable comfortable processing. A stepping stone to this was our evaluation of VPX for further concentrating harvests and improving the chromatography efficiencies.
Aishwarya Ramanan is part of the Seagen Purification BioProcess Development Group and focuses her efforts on process analytical technology (PAT) strategy evaluation and process intensification implementation for the downstream purification process. She received her Master's in Bio-Pharmaceutical Engineering & Biotechnology from University of Pennsylvania and has over 8 years of experience specializing in downstream process development. She continues to drive innovation and optimization to the purification process.
Expert Panel Roundtable Discussion – Hosted by Ralf Kuriyel, Senior Vice President, Research and Development
Ralf Kuriyel
Panel Discussion: Our panel will talk about the advantages and disadvantages with variable pathlength technology (VPT). They will discuss their experience in evaluating, implementing and/or validating in-line VPT as part of their PAT strategies. 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
Ralf Kuriyel joined Repligen in October 2016 as the Senior Vice President, Research and Development where he oversees the Company's R&D efforts. Mr. Kuriyel was previously Vice President of Applications for the single-use business unit within the Life Sciences division of Pall Corporation ("Pall"), whose acquisition by Danaher Corporation was completed in August 2015. At Pall, Mr. Kuriyel served as Vice President of R&D, Field Applications and Process Development Services from November 2014 to October 2016. In addition, Mr. Kuriyel served as Vice President, Applications R&D at Pall from November 2011 to November 2014. Mr. Kuriyel received a B.S. and an M.S. in Chemical Engineering from Rensselaer Polytechnic Institute and has completed his coursework for the Tufts University Ph.D. program in Chemical Engineering. He is an inventor of multiple patents and has co-authored over 30 scientific publications on bioprocessing, including separations technologies, membrane separations methods, protein processing and enhanced microfiltration techniques.
Jay West, Senior Principal Scientist – Bristol Myers Squibb
Renata Pocitarenco, Associate Scientist – Janssen Pharmaceuticals
Marius Mueller, Team Lead Analytical Fill-Finish Support – Janssen Pharmaceuticals
Aishwarya Ramanan, Senior Research Associate – Seagen
Please fill out the form below to register
Please select webinars to register for:
Full Series (All 4 Webinars)
The CTech FlowVPX System is an in-line variable pathlength solution for concentration measurement in biologic process development and GMP manufacturing. Would you like a Repligen analytics technical professional to contact you to learn more about the FlowVPX System?
By clicking this button, you submit your information to the webinar organizer, who will use it to communicate with you regarding this event and their other services
State Alabama Alaska Alberta Arizona Arkansas British Columbia California Colorado Connecticut Delaware District Of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Manitoba Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Brunswick New Hampshire New Jersey New Mexico New York Newfoundland North Carolina North Dakota Northwest Territories Nova Scotia Nunavut Ohio Oklahoma Ontario Oregon Pennsylvania Prince Edward Island Quebec Rhode Island Saskatchewan South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Yukon Would you like a Repligen analytics technical professional to contact you to learn more about the FlowVPX System? * Yes No
C Technologies, Inc.
685 Route 202/206 Bridgewater, NJ 08807 USA
© Copyright 2023 C Technologies, Inc. | All Rights Reserved
Call us: +1 908-707-1201 USA
E-mail us: support@ctechnologiesinc.com
We've updated our Privacy Policy
You must agree to our new policy to continue using our website
By checking the box, you have read and agree to the updated Terms of Service and Privacy Policy
For security reasons, we will need to log you out in:
Yes, Keep me logged in
No, Log me out
Browser is unsupported. Some functionality may be missing. Please use Chrome, Firefox, or Edge for optimal viewing. x