The SILCS approach to modeling protein – excipient interactions to predict biologics formulations
The SILCS-Biologics toolset utilizes the SILCS platform technology in a novel way to direct and inform in silico biologics formulations through mapping of protein-protein interactions and comprehensive excipient modeling. The technology is applicable to all classes of proteins including monoclonal antibodies (mABs)
A computational approach to expediting the biologics formulation process
Biologics are formulated to maintain their activity during long-term storage and subsequent administration. Maintaining their 3D conformations and preventing protein aggregation is an important challenge in their development. Experiments to identify the optimal combinations of excipients, buffers, and surfactants are low throughput and require high concentrations of protein – which is limited and costly. Failure to determine the optimal formulation results in decreased product performance; impacting patient treatment and in some cases requiring the costly reengineering of the therapeutic protein.
SilcsBio has developed a novel in silico formulation design technology to inform the selection of desired excipient/buffer combinations. With the help of the established SILCS platform, SilcsBio’s technology 3D maps the protein of interest (FragMap) and its functional group affinity pattern, setting the foundation for evaluation of the full range of protein-protein interactions and the full distribution of buffers and excipitents on the protein, data that may be used to rationally enhance stability, limit viscosity and prevent aggregation.
The SILCS-GUI provides a point and click approach to protein system preparation and SILCS simulation job submissions for FragMap generation. After the simulations are complete, the GUI allows for readily performing all steps of the SILCS-Biologics workflow allowing for ready access to the full capabilities of the technology.
SILCS Biologics utilizes the FragMaps to perform mapping of protein-protein interactions (PPI) and the distribution and affinity of excipients and buffers on the entire protein surface. That information is then combined yielding an information-rich dataset that may be used to direct biologics formulation, including interpretation of experimental data and predictions of excipients that could modulate desirable properties of the biologic formulation. This technology has been applied to a range of protein biologics including monoclonal antibodies.
The SILCS technology allows screening of 100’s of excipients and buf-fers as well as protein-protein interaction (PPI) within a day, minimizing the need for experimental screening.
Excipient/buf-fers combinations in silico guided by SilcsBio’s approach lowers costs and timelines in developing novel biologics
Improved formulations to better maintain the stability of biologics during storage and delivery.
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