Tools for the Analysis of New Biotherapeutic Drug Modalities: A sponsored virtual symposium

This event is now available on-demand!

Event Overview:

With the rise of biotherapeutics, more comprehensive analytical solutions are needed to address new drug modality characterization and quantification challenges. This symposium will explore and discuss innovative chemistry solutions to address these challenges. Applications will showcase how modern approaches achieve reproducible and reliable workflow performances from biotherapeutic discovery through QC analysis.

Key Learning Objectives:

- Learn about innovative column chemistries and its benefits for protein characterization and quantification workflows
- Discover how to mitigate risks and develop right-the-first time biotherapeutic analytical methods
- Gain insights from protein experts to troubleshoot biotherapeutic analytical methods

Who Should Attend:

- Analytical scientists developing LC analytical methods for biotherapeutics
- Managers looking to increase analytical development operational excellence
- Anyone interested in learning and improving biotherapeutic analytical development skills

Agenda:

Morning Session

1. The Evolution of Separation and Sample Preparation Solutions for Biotherapeutics
Tran Pham, Global Market Development Manager - BioPharma
Introduction to addressing current challenges of characterizing and quantifying biotherapeutics with modern chemistry stationary phases

2. Advanced Size Exclusion Solution Focusing on Column Lifetime and Inert Surface
Dr. Helen Whitby, Senior Product Manager – BioPharma
Since the early introduction of biologic based therapeutics, it has been known that the presence of protein aggregates can compromise safety and efficacy. These protein aggregates are typically monitored throughout the production of a biotherapeutic, therefore, Size Exclusion chromatography (SEC) continues to be the dominant technique for analysis of soluble aggregates

3. Method Development Strategies for Purity Analysis of Proteins by Intact and Subunit Analysis
Dr. Helen Whitby, Senior Product Manager – BioPharma
Method development for intact and subunit purity analysis for mAbs by RPLC will be discussed. This includes best practices in method optimization, including how to best adjust method parameters such as temperature, gradient slope, and flow rate to obtain high-quality impurity profiling and ensure method robustness and reproducibility.

4. Intact and Subunit Analysis Panel Q&A Session
A panel of technical experts answering questions about a widepore column chemistry solution for intact and subunit analyses.

Afternoon Session

1. Improvements in Sample Preparation and LC-MS Analysis of Therapeutic Oligonucleotides
Ivan Lebedev, Senior Application Scientist
An overview of sample preparation strategies for synthetic oligonucleotides, including how to adjust experimental design depending on the oligo and sample matrix. The presentation will also go into depth about the critical parameters to adjust to ensure effective sample preparation and clean-up methods are implemented. Additionally, method optimization for small volume sample extraction and clean-up solutions for oligonucleotides will be explored to further optimize challenging methods.

2. What You Need to Know: Micro and Nano Low Flow LC Essentials
Roxana Eggleston-Rangel, Senior Application Scientist
A review of micro and nano LC fundamentals and a selective approach to trap and column strategies to increase method performance. Chromatographic low flow examples, along with trap selectivity comparisons, and how to find the best micro and nano low flow selectivity strategy for your application will be presented.

3. Size Exclusion Chromatography - Native High Resolution Mass Spectrometry for the Characterization of Monoclonal Antibodies
Lorne Nelson, Senior Scientist - Field Applications
SEC can be combined with high-resolution mass spectrometry (HRMS) to obtain even more detailed characterization data for mAbs. Here we demonstrate how non-denaturing SEC-Native MS can be leveraged to streamline mAb characterization, including methods for digestion of mAbs using site-specific proteases to obtain further insight on post-translational modifications. Column selection, including pore volume and column dimensions to ensure monomer and aggregate resolution, and mobile phase optimization are addressed.

4. Panel Q&A with Technical Experts (Ivan, Roxana and Lorne)

For any technical questions please contact Lindsay Petrocelli: LPetrocelli@mjhlifesciences.com

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Tools for the Analysis of New Biotherapeutic Drug Modalities: A sponsored virtual symposium

Complete this form to enter the webcast.
(* indicates required field)