// Oct 01, 2026 | Fierce Biotech
Accelerating CGT Product Release: The Role of Next-Generation Sequencing and Automated Analytics
Adriana Geldart Ph.D.
Senior Director of Analytical Development & Next-Generation Sequencing
Michael Giffin, Ph.D.
Director, Analytical Development
Will Arnold, Ph.D.
Principal Scientist
Overview
The traditional 14-day sterility test is a critical bottleneck in therapy release. NGS offers a powerful and ideal solution, cutting this time down to just a few days while providing more comprehensive safety data.
The long-term vision is to automate the entire suite of release assays. This integration creates a standardized, high-throughput system that not only accelerates current timelines but also lays the groundwork for future predictive product release.
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About the Author
Adriana Geldart Ph.D.
Senior Director of Analytical Development & Next-Generation Sequencing
Adriana Geldart Ph.D. is a senior biotechnology leader with deep expertise in analytical development, next-generation sequencing (NGS), and molecular biology. She currently serves as Senior Director of Analytical Development & Next-Generation Sequencing at ElevateBio, where she leads strategy and innovation in analytical sciences to support the development of advanced cell and gene therapies. Since joining ElevateBio nearly five years ago, she has held progressively senior leadership roles, including Director and Senior Director of Next-Generation Sequencing.
Prior to ElevateBio, Adriana spent nearly eight years at Roche, where she held roles of increasing responsibility, most recently as a Pathology Solutions Specialist within Tissue Diagnostics.
Adriana began her scientific career as a postdoctoral fellow at Brigham and Women’s Hospital, building on a strong academic foundation in biomedical research. She earned her Ph.D. in Biomedical Sciences from UMass Chan Medical School and a Bachelor of Science in Biology from Stonehill College.
Michael Giffin, Ph.D.
Director, Analytical Development
Is his almost twenty years in the biotech industry, Mike Giffin, Ph.D. has supported multiple modalities, including large molecules, cell and gene therapy, mRNA and LNP. He has led and supported programs across the full development lifecycle, from discovery to clinical stage, with some advancing to marketed products. He has contributed authorship to numerous regulatory filings, including INDs and ODDs. Dr. Giffin has led analytical development teams supporting cell and gene therapies, overseeing the development and qualification of fit-for-purpose methods for characterization, comparability, in-process control, and product release, employing risk-based QbD strategies to develop comprehensive and phase-appropriate control strategies. Dr. Giffin’s technical background spans (LNPs), lentiviral vectors and engineered cell therapy platforms. He currently leads the Analytical Development team at ElevateBio.
Will Arnold, Ph.D.
Principal Scientist
Will Arnold, Ph.D. is a Principal Scientist in ElevateBio’s Technical Services Group focused on bioinformatics, data infrastructure, and Bio-IT services. In this role, he develops and leads data-intensive initiatives across the ElevateBio ecosystem with a current major focus on computational approaches leveraging next-generation sequencing (NGS) for rapid analytics in manufacturing.
Prior to ElevateBio, he spent nearly four years as a Quality Control Scientist at the non-profit vector repository, Addgene, where in addition to performing QC activities on the repository he led the onboarding of in-house NGS.
Dr. Arnold earned his Ph.D. in Microbiology, Immunology, and Molecular Genetics at the University of Kentucky where he leveraged high-throughput sequencing and the full suite of molecular methods characterizing gene regulatory systems in pathogens. He also holds a B.S. in Biology from the University of Kentucky.
