In Silico Development Assessment

In Silico Development Assessment Overview

Summary of sequence-based analysis table
Table: Summary of sequence-based analysis: Including PTM sites, Hydrophilicity, CDR length, Charge of antibody

Early assessment of lead monoclonal antibody candidates can help prevent delays in the later stages of development, making developability assessment increasingly important. The concept of developability is based on insights gained from the successful development of approximately 80 marketed antibody and Fc-fusion protein drug products, as well as lessons learned from numerous failed development programs over the past 30 years.

Without comprehensive characterization to understand the biochemical and biophysical properties of the selected candidates, unexpected modifications, stability issues, or adverse PK and PD can lead to project delays or even termination. Development risks are often related to the inherent properties of candidate drugs. Therefore, conducting a developability assessment before entering process development is crucial. Developability assessment is a systematic evaluation of candidate drugs, including structural evaluation, safety, PK and PD, and manufacturability.

Early assessment of lead monoclonal antibody candidates can help prevent delays in the later stages of development, making developability assessment increasingly important. The concept of developability is based on insights gained from the successful development of approximately 80 marketed antibody and Fc-fusion protein drug products, as well as lessons learned from numerous failed development programs over the past 30 years. Without comprehensive characterization to understand the biochemical and biophysical properties of the selected candidates, unexpected modifications, stability issues, or adverse PK and PD can lead to project delays or even termination. Development risks are often related to the inherent properties of candidate drugs. Therefore, conducting a developability assessment before entering process development is crucial. Developability assessment is a systematic evaluation of candidate drugs, including structural evaluation, safety, PK and PD, and manufacturability.

KYinno has developed a computer-assisted antibody developability analysis system based on antibody sequences and structural information. First, using the sequence information of the antibody variable regions, we analyze a series of drugability and developability parameters. These parameters include post-translational modification sites analysis, solubility and aggregation analysis in the CDR regions, length analysis, charge analysis, and stability analysis of the CDR regions. We have compiled sequence information from all approved antibody drug products and summarized primary sequence properties of the CDRs in all these approved antibody drugs. The sequence information of the target antibody is color-coded to indicate whether it falls within the range of these approved drugs. Regions that require special attention are marked in red. See the table below for details.

Surface hydrophobicity analysis
Figure: Surface hydrophobicity analysis:Yellow color is hydrophbic aera of CDR, blue and red color are hydrophilic aera of CDR

We will also perform Homology Modeling based on the sequence of the target antibody’s variable regions. During modeling, we will select crystal structures of the heavy chain framework region, heavy chain CDR, light chain framework region, and light chain CDR as reference templates for homology modeling, striving to accurately predict the antibody’s structure.

Using the accurately predicted structure of the antibody’s variable regions, we will conduct structure-related developability analysis, including analysis of the hydrophobic and hydrophilic properties on the antibody CDR surface, charge distribution on the CDR surface, hydrogen bonds and salt bridges within the CDR structure, as well as translation modification site analysis based on the CDR surface structure, and more.

Finally, a comprehensive assessment of the target antibody’s developability will be made based on all of this information.

Surface charge analysis

Figure: Surface charge analysis: Blue color is positive charge aera of CDR, red color is negative charge aera of CDR

Figure: Surface dyrogen bond analysis of CDR

Figure: Saltbridge analysis of CDR

Posttranslational modifications (PTMs) analysis of CDR

Figure: Posttranslational modifications (PTMs) analysis of CDR

All Antibody Discovery Services

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In silico developability assessment, transforming biomedicine by providing groundbreaking approaches to predicting antibody developability. Leveraging advanced computational insights, streamline research processes, enhance therapeutic product robustness, and accelerate innovative drug discovery.
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Nanobodies, featuring high affinity and stability, revolutionize therapeutic approaches. Their unique properties make them invaluable, especially in the areas of targeted drug delivery, advanced diagnostics, and innovative disease intervention strategies.
KYINNO sets the standard, prioritizing high-quality antibody production. We emphasize unmatched consistency, purity, and reliability, setting industry guidelines, fostering trust, and accelerating groundbreaking drug discovery and innovative research endeavors.
Bispecific antibodies from KY-CLC bind two distinct antigens, offering advanced therapeutic avenues, enhancing drug delivery, and increasing the potential for successful patient outcomes.
Nanobodies, known for their small molecular weight, high affinity, stability, permeability, and cost-effectiveness, have demonstrated tremendous potential in disease …