Smooth cell therapy analytical assay translation from analytical development to QC

Cell & Gene Therapy Insights 2024; 10(1), 117–127

DOI: 10.18609/cgti.2024.019

Published: 28 February
Expert Roundtable
Hadar H Adams, Ilya Shestopalov, Kitman Yeung, Takele Teklemariam

In this Expert Roundtable, four experienced industry professionals, Hadar H Adams, Ilya Shestopalov, Kitman Yeung, and Takele Teklemariam, discuss challenges and strategies for effective assay translation in the cell therapy space, with a particular focus on flow cytometry assays. The panelists share insights on effective communication between analytical development and QC teams, risk mitigation, and regulatory considerations.

Hadar H Adams is the Director of Analytical Development at Atara Biotherapeutics, an allogeneic T cell immunotherapy company. She has over 10 years of experience in development, optimization, troubleshooting, qualification/validation, and transfer of analytical methods for diagnostic testing, release testing, stability, and characterization of biological and cell therapy drug products. In her current role, Hadar leads a team focused on developing and qualifying a wide range of assays to support an IND for a CAR-T drug product.

Ilya Shestopalov is currently the Vice President of Analytical Development and Analytical Product Lead at bluebird bio. His research focuses on development of cell-based assays for hematopoietic stem/progenitor products, CAR-T products, and lentiviral vectors. Prior to bluebird bio, Shestopalov was a postdoctoral fellow in stem cell biology at Boston Children’s Hospital and Harvard University working with zebrafish hematopoietic stem cells.

Kitman Yeung is a biopharmaceutical specialist at Miltenyi Bioindustry, a division of Miltenyi Biotec, with 15 years of experience in cell and gene therapies. Her expertise in technology transfer, analytical development, and quality control testing supports the production of Phase 1/2 GMP cell and gene therapies. Yeung is currently an MSAT Analytical Manager at Miltenyi Bioindustry, where she leads technical and operational teams in developing, characterizing, and qualifying analytical tools for cell and gene therapies across multiple modalities.

Takele Teklemariam is a Quality Control Professional at Miltenyi Biotec with 15 years of experience in cell and gene therapy. He has broad experience in QC assay design and development, assay transfer, and qualification/validation. Currently, Takele is Associate Director of Analytical Development and QC Assay Transfer at Miltenyi Biotec, where he leads QC assay development and transfer, assay qualification and validation, stability studies, and QC in-process and release testing in cell and gene therapy for multiple clients.