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

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

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

In this expert roundtable, four experienced professionals with industry and regulatory backgrounds discuss strategies for effective assay validation in the cell therapy space, with a particular focus on flow cytometry assays. Panelists will include:

Christopher Bravery, PhD, Director, Consulting, Advanced Biologicals Ltd
Michelle Bruno, Head of QC (North-America), Miltenyi Bioindustry
Ajit Kamath, Senior Scientist II, Analytical Development, Beam Therapeutics
Lili Wang, Research Chemist, National Institute of Standards and Technology (NIST)

The panelists discuss complexities arising from accelerated timelines and cellular product heterogeneity, and share how Quality by Design principles ensure robust assays.

Master complexities arising from accelerated timelines in assay validation
Discover the crucial role of Quality by Design principles in ensuring robust assays
Explore innovative technologies and ensure regulatory compliance

Christopher Bravery

Director, Consulting at Advanced Biologicals Ltd

Christopher Bravery is Director, Consulting on Advanced Biologicals and Consulting Regulatory Scientist at Advbiols Ltd. Advbiols Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis. Christopher has a PhD in Xenotranplantation Immunology and spent eight years in biotech (Imutran Ltd, A Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a Quality (CMC) Assessor (biologicals and biotechnology unit). Christopher was involved with the national implementation of the new Advanced Therapies Regulation and, through his participation in the Committee for Medicinal Products for Human Use cell products working party, in implementation at the EMA level, including drafting guidelines.

Michelle Bruno

Head of QC at Miltenyi Bioindustry

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

Senior Scientist II, Analytical Development at Beam Therapeutics

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

Research Chemist at National Institute of Standards and Technology (NIST)

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.