The Importance of Comprehensive Biophysical and Functional Characterizations in Antibody Development

The development of therapeutic antibodies for clinical development requires rigorous characterizations. In order to develop safe and effective antibody-based drugs, engineering of optimal biophysical and functional properties is essential. By integrating 

 we can facilitate our partner’s competitive positioning by accelerating the development process to bring life-saving treatments to patients.

Functional Characterizations Demonstrate Biological Activity

 is essential for assessing the biological activity of an antibody. This process involves performing various assays specifically designed to evaluate how an antibody interacts with its target and exerts its intended therapeutic effect. To confirm the mechanisms of action to meet the desired TPP, a range of assays that can span assessments from affinity and kinetics to cell activation and internalization can be performed.

Biophysical Characterizations Confirm Structural Stability

 of the physical and chemical properties of an antibody-based molecule can drive more rapid and lower cost transitions into the CMC process. Comprehensive biophysical characterizations during candidate selection, including assessments of aggregation, charge heterogeneity, and hydrophobicity, can derisk lead compound instability during clinical development.

The Synergy of Functional and Biophysical Characterization

Antibody Characterization

At FairJourney Biologics, we understand that offering orthogonal insights is critical for the successful selection of a therapeutic agent by guiding the selection and optimization processes. Neglecting either characterization assessment compromises the selection of potent, efficacious, and stable candidate molecules for antibody development.

Get a closer look on why integrating both types of characterization is indispensable:

: Functional assays alone cannot provide complete information about an antibody's stability and developability profile. Similarly, biophysical characterization alone cannot fully predict biological efficacy and safety.

: Insights from both characterizations facilitate the rational design and optimization of therapeutic antibodies. Together, comprehensive evaluation of functional and biophysical characterizations can better guide informed modifications to enhance lead optimization.

: Regulatory agencies require confirmation of critical quality attributes that are based on extensive characterization data for the approval of therapeutic antibodies. Integrating comprehensive characterizations enhances the lead therapeutic molecule potential to meet the high standards required for regulatory agency approval.

: Thorough characterization helps identify potential issues early in the development process, reducing the risk of late-stage failures. This leads to more efficient and cost-effective development pipelines.

Stay tuned for more insights on antibody development and characterization. Follow us on 

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Ensuring excellence through rigorous Antibody Characterization

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