Leveraging real-time concentration data to increase accuracy with automated UF/DF for cGMP manufacturing

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

For cGMP manufacturers of advanced therapy medicinal products (ATMPs) focused on optimizing suites, the removal of risk factors is critical. Tangential flow filtration (TFF) processing that relies on upfront calculations or vessel concentration estimates, rather than real-time insights, produces a wide variety of challenges for operators. To combat the risks associated with faulty volume calculations, process variability, and batch inconsistencies, Repligen is expanding TFF innovation with a new series of integrated systems- the KrosFlo® RS RPM™ TFF system.

During this webinar, we will conduct an application note review examining an ultrafiltration/diafiltration (UF/DF) process using bovine serum albumin (BSA) to assess the capabilities of the KrosFlo RS 30 RPM TFF system. Powered by its integration with the CTech™ FlowVPX® spectrophotometer with variable pathlength technology, the KrosFlo RS RPM demonstrated concentration accuracies of over 30% compared to mass balance calculations.

In this webinar, you will discover:

• How to leverage live concentration data in real time to enable automated process transitions during TFF operations
• How real-time, in-line concentration measurement can increase accuracies by over 30% as compared to upfront calculations or vessel weight
• How Process Analytics Technology (PAT) driven cGMP TTF systems enable operators to adapt for variability while limiting offline sampling and dilution

Jigar Patel

Senior Bioprocess Applications Engineer at Repligen

Part of the Bioprocess Field Applications Team at Repligen, Jigar has spent 10+ years supporting biopharmaceutical customers in various roles for at-line and in-line Variable Pathlength Products (VPT). His focus for the last 6 years has been on the in-line VPT product line (FlowVPE/X) and its implementation into process development and GMP manufacturing areas for concentration monitoring and control. He obtained a BS degree in Biomedical Engineering from Rutgers University (New Brunswick, NJ) and a MS degree in Biomedical Engineering from Drexel University (Philadelphia, PA).

Steven Cates

Vice President, Research & Development at Repligen Corporation

Steven brings more than 30 years of biopharmaceuticals industry experience to the table, with a strong emphasis on system design and manufacturing. Throughout his tenure, he has led engineering operations for process filtration and analytical equipment, managed teams specializing in custom-engineered bioprocessing systems, and founded organizations. Today, he oversees the global design and development of single-use bioprocess systems, from R&D and process development down to manufacturing and implementation. Steven has a BS in Electrical Engineering from Sonoma State College and an MS in Molecular Biology from Stanford University.

Watch now

SPEAKERS

Jigar Patel

Senior Bioprocess Applications Engineer at Repligen

Steven Cates

Vice President, Research & Development at Repligen Corporation

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