Webinar Description:
Therapeutic proteins, antibodies, and antibody drug conjugates are at the center stage of the pipeline of almost every pharmaceutical company. The complexity of these large molecule therapeutics makes them susceptible to numerous post-translational modifications and other variants which may have detrimental effects on efficacy, stability or immunogenicity. Mass spectrometry-based peptide mapping provides information on many important molecule attributes such as post-translational modifications (PTMs), clipping, glycosylation and sequence variants. However, given the complexity of analysis, data processing often requires multiple software packages and extensive manual interpretation, thus slowing timelines and introducing risks of variability for interpretation and reporting. As biotherapeutic development advances, how can laboratories gain modern efficiencies that support the forefront of their research?

In this webinar, Drs. Nanda and Carlson will demonstrate the acceleration of analysis time that is possible when using modern software and automation developed to support biotherapeutic development. Dr. Hirsh will describe how he efficiently characterized and reported on sets of candidates in parallel for developability and for clone selection workflows using Protein Metrics’ new software platform, Byos™, in a fully automated scenario. He will show how his lab identifies early optimal robust candidates for Development using a scalable method to rapidly process multiple samples for a given target in order to evaluate each for its biochemical stability after exposure to forced degradation conditions (thermal, oxidation, low and high pH). Dr. Nanda will also discuss how his lab has improved clone selection by screening multiple clones and automatically assessing candidates based on a profile of product quality attributes such as glycosylation profile, signal peptide processing, N/C-terminal clipping, and sequence variants. For both workflows, multiple proteolytic enzyme peptide map data can be processed simultaneously providing additional validation of reported modifications.

Dr. Carlson will demonstrate the how smaller sets of samples can be rapidly and consistently processed with the Byos™ platform to quantitatively compare multiple lots of biosimilar and originator samples. A multi-attribute method (MAM) was applied to assess differences in oxidation, deamidation, glycation, glycosylation, and N/C-terminal clipping. While the samples were substantially similar, Dr. Carlson will show differences in a-fucosylation that correlate with difference in Fc-binding studies.

Learning Objectives

• How to employ stream-lined data workflows for mass spec analysis to impact clone selection and early development
• How a fully-automated analysis pipeline can change the way a development group approaches clone selection and early development
• How to measure and report PTMs (oxidation, deamidation, isomerization), glycans, N/C-terminal heterogeneity such as unprocessed signal peptide or clipping as well as sequence variants using mass spectrometry in an efficient manner
• How to slash the time involved in reporting and ensure consistent reports across the group by automatically populating reports and summaries of analysis from report templates
• How to report quality attributes to managers and non-specialists automatically
• How having product quality data immediately available can facilitate decision-making in a modern biologics organization

Speakers:

Eric Carlson, Ph.D.
President and CEO
Protein Metrics

Building successful and innovative scientific companies has been in Eric’s DNA for almost two decades. He thrives on the challenge of developing novel products that help laboratories advance scientific research.

Eric joined Protein Metrics in 2014 as Chief Business Officer and was chosen to become President and CEO in 2017. Under his leadership, the company continually launches products that produce significant benefit to researchers and laboratories worldwide. Before joining Protein Metrics, Eric was a co-founder and senior vice president of Freeslate and spent 12 years at Symyx Technologies.

He received his M.S. and Ph.D. degrees in Chemical Engineering from Stanford University. He has also authored 32 published patents and is the lead author on a chapter on automation for stress testing studies in “Pharmaceutical Stress Testing: Predicting Drug Degradation,” 2nd Edition (Informa, 2011).

Hirsh Nanda, Ph.D.
Associate Director and Team Manager, Cell & Developability Sciences
Janssen Pharmaceuticals

Hirsh joined The Janssen Pharmaceutical Companies of Johnson & Johnson in 2015 as a Senior Scientist and Team Manager of the Analytical Discovery Department. In this role, he leads a group of mass-spec scientists in the characterization of large molecule biologics (mAbs, bispecifics, scaffold proteins, ADCs, and native proteins). He also provides primary support for Therapeutic Areas and Biologics Research in discovery and early phase development as well as for some late phase development projects.

He is responsible for protein characterization (assessing chemical and physical degradation risks in lead candidates, characterizing oxidation, deamidation and clipping, and assessing signal peptide processing, glycoform ID, and sequence variance throughout lead-optimization to candidate selection and cell line development; antibody sourcing (de novo sequencing for antibody sourcing and tool antibody development); and high-throughput mass-spec analysis (lead development of automated pipelines, large volume sample processing, and managing CROs).

Prior to joining Janssen, Hirsh was a Senior Scientist at NIST and Carnegie Mellon University, and was a Post-Doctoral Researcher at Amgen and NIST. He received his Ph.D. in Biophysics from The John Hopkins University School of Medicine, and his B.S.E in Biomedical Engineering from Duke University.