Humam Al Rubaye

Supported Regeneron Genetic Medicine potency bioassay and off-target analysis teams for our lead gene therapy/editing programs.

• Potency Bioassay Design: Led the development of potency assays, including cell line and method selection (ELISA, Western blot, luminance-based reporter assays).
• Fit-for-Purpose Qualification: Conducted rigorous qualification to ensure assays meet precise accuracy and reproducibility standards.
• Assay Transfer to CROs: Successfully transferred assays to CROs, providing training and support to ensure consistent execution.

• Contributed to genomic off-target studies for liver programs using primary hepatocytes and immortalized cell lines.
• Performed experiments to assess insertion rate, indel frequency, and protein production for AAV/LNP products.
• Conducted flow-based, Western blot, and RT-qPCR validation for cell lines overexpressing constructs (transfection or stable lentivirus engineering) or knockout clones using CRISPR guides.

Support for Therapeutic Antibodies teams

• Conducted potency bioassay sample testing for therapeutic antibody projects.
• Screened antibodies to identify high-performing candidates.
• Spearheaded Therapeutic Antibodies team to aggregate and analyze data on a data lake to streamline data management and facilitate comprehensive analysis.

Support for AAV Production and Purification

• Produced and purified AAVs on a large scale, ensuring high yield and quality.
• Performed analytical testing including genomic titer, full vs. empty capsid, and protein expression assays to validate production runs.