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Why the first step in effective analytical characterization of biologics should be knowing stability

2 min read
Apr 3, 2020

Successful characterization of any biologic should start by first monitoring stability as it is closely linked to its functional activity. Also, stability plays a key role in determining the optimal storage and formulation conditions required to develop a biologic.

In this on-demand presentation, NanoTemper’s Dr. Peter Fung shares the importances of monitoring stability throughout all steps in characterizing a biologic.

Here’s what you’ll learn.


1. Understand why the journey to bring a drug to market is challenging
In order to look at ways to improve analytical characterization of biologics, it’s first important to understand the challenges. In a 2019 Nature Reviews Drug Discovery article by Dowden et. al., the authors shared that almost half of the compounds that make it to phase III trials will fail. For compounds entering phase I trials the success rate is only 10%. These success rates haven’t improved over the last two decades. Despite increased spending on R&D costs, the success rate of bringing drugs to market faces many hurdles.


2. Realize how efficient biologics characterization includes monitoring protein stability
Stability is a critical quality attribute researchers should consider monitoring early on and throughout their workflow steps when identifying their lead biotherapeutic candidates. Stability is tightly linked to the functionality activity of a therapeutic monoclonal antibody (mAb). A protein lacking stability, will likely unfold, aggregate and lose it’s activity. Therefore, researchers should consider monitoring stability early on and throughout their characterization and developability workflow steps achieve more efficient and successful therapeutic candidate selection. Learn how scientists at Boehringer-Ingelheim Pharma GmbH & Co. KG, efficiently and effectively predict long-term stability of mAb candidates by measuring both conformational and colloidal stability.


3. Discover why successful optimization and selection of lead biotherapeutic candidates typically requires testing many conditions that affect stability
Biologics such as monoclonal antibodies are complex molecules that often require specific formulation and storage conditions to maintain their function. Optimizing and testing to identify the best conditions can be a daunting task as it often requires screening numerous conditions. The goal is to identify the condition that maintains the stability of a biologic without compromising it functionality and to do this in the shortest amount of time. Having an instrument like Prometheus enables researchers to have throughput and automation options to address their testing needs.


The time invested to bring a mAb biotherapeutic to market can take years and is a daunting task. Knowing the stability of your target will lead to more efficient selection of the best lead candidates to follow-through on to develop into new drugs

Watch the webinar to learn more.

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