Entering the fast lane of assay validation for cell and gene therapies

Michelle Bruno is a seasoned expert in quality control within the bioindustry. With extensive leadership experience, including roles as Head of Quality Control at Miltenyi Biotec and Director of Quality at Lentigen Technologies, Michelle brings invaluable insights into process optimization, regulatory compliance, and driving quality initiatives.

Ajit Kamath is a Senior Scientist II at Beam Therapeutics, working in Analytical Development. He has over six years of Analytical Development experience in developing phase-appropriate methods to support product development, including flow cytometry, immunophenotyping, and cell-based analytics. In his current role, he is supporting late-stage method development and characterization for cell and gene therapies. Ajit holds a PhD from Boston University in Molecular and Cellular Biology.

Lili Wang is an NIST fellow and a leading expert in quantitative flow cytometry critical for diagnostics and advanced therapeutic development. She serves as the principal manager for the NIST Flow Cytometry Standards Consortium, a major Public-Private Partnership with key stakeholders from other agencies, industries, and academia, which addresses pressing measurements and standards needed for bioassays. In collaboration with WHO, her team has established multiple standards, including critical reference materials for HIV/AIDS monitoring, stem cell counting for blood transplantation, and most recently, the first and second international serology/antibody standards.