Webinar Description:

While running a viral inactivation (VIN) process, there is no sample testing to see if the protein is unfolding at low pH. Samples are tested before and after for information on aggregation and chemical degradation, but nothing is performed in real-time to assess changes during the process, in the low pH buffering conditions.In this webinar, Janssen will present a study where the Amide I Band data is monitored hourly using Microfluidic Modulation Spectroscopy (MMS), in samples split form a single preparation of mAb at low pH, mimicking a VIN low pH hold.

MMS provides high resolution structural information, critical to understanding the effects of the purification process on your biotherapeutic drug. Scientists today are challenged in gathering a complete understanding using available techniques. During biomanufacturing, for example the VIN process, proteins such as monoclonal antibodies, often undergo conformational changes that can alter their secondary structure, leading to critical variations in their overall function. These changes have been historically difficult to detect, as traditional analytical techniques are not great at detecting small differences in protein structure. MMS however, can detect these changes with great sensitivity and accuracy without the need for dilution or chemical alteration.

In this webinar, Janssen will demonstrate that a significant change in the conformation of the mAb was observed. The MMS data shows that protein secondary structure analysis can be performed in combination with viral inactivation testing to determine preferred, optimized VIN hold time for downstream processing.

Learning Objectives:

• How Microfluidic Modulation Spectroscopy (MMS) can be used to monitor, in real time, conformational changes in a monoclonal antibody
• Introduction to the AQS3™pro MMS system from RedShiftBio

Webinar Highlights:

• Characterization of mAb’s in conjunction with viral inactivation testing, enabled by MMS, is critical to understand the TRUE structure of your drug product in downstream processing.
• Microfluidic Modulation Spectroscopy provides a reliable platform with increased sensitive and higher resolution for secondary structure analysis of biotherapeutics.
• MMS’s Automated walk away workflow makes it applicable for screening studies much earlier in the development process.

Speakers:

Steven LaBrenz
Scientific Director
Janssen R&D - PDMS

A protein chemist, Steven’s experience includes formulation development and process sciences. Skilled in all aspects of chromatography and applied molecular spectroscopy.

Eugene Ma
Technology Innovation and Technical Support
RedShiftBio

Prior to RedShiftBio, Eugene was co-founder and CTO at Aegis Lightwave where he developed its Active Thin Film technology from initial concepts to commercial production of the telecom-qualified devices currently being used today in DWDM optical networks.

Cost: No Cost!