Innovations in therapeutic modalities are continually emerging as viable treatment options for a multitude of disease indications. These novel therapies can be complex biologics with multiple product components such as bioconjugates, volume limited therapies where the suit of established characterization and release testing cannot be performed due to low volumes as in the case of certain Cell and Gene therapies or molecules that are invisible by established analytical tools. Re-evaluation of established analytical technologies or reimagining the use of established analytical tool kits to provide novel characterization approaches can accelerate and enhance product understanding.

In this session we will explore case-studies where established technologies are enhanced or leveraged in a novel manner to characterize complex therapeutic modalities. Additionally, we will explore the current state of the art analytical tools utilized for process analytical technologies and release testing. We will discuss which technologies are QC ready and which remain as characterization tools in the development labs. This session will highlight the evolving trend of reimagining established analytical technologies to tackle the characterization and product release challenges posed by the modern-day innovative therapies.

Session Speaker:

A Novel, High-Throughput Imaged Capillary Isoelectric Focusing (iCIEF)-Western Method to Characterize Charge Heterogeneity of Monoclonal Antibody (mAb) Heavy and Light Chains

Gangadhar Dhulipala, Regeneron Pharmaceuticals Inc.

Genetic Medicine Characterization via 2nd and 3rd Generation Sequencing Tools

Beth Ostrander, Pfizer, Inc.

Carly Daniels, Pfizer, Inc.

Additional Panelists:

Methal Albarghouthi, AstraZeneca

Da Ren, BioTherapeutics Solutions

Nadine Ritter, Global Biotech Experts, LLC

Yi Zhang

Appearances