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Webinar

Accelerating CGT Product Release: The Role of Next-Generation Sequencing and Automated Analytics

Available on-demand
60 Minutes

The clinical impact of cell and gene therapies (CGTs) can be limited by a critical challenge: product release. Traditional release assays are often manual, time-consuming, and can take weeks to complete, delaying patient treatment and tying up valuable manufacturing resources.

Join us for this insightful webinar to explore the shift toward automating critical release steps, with a focus on the potential of next-generation sequencing (NGS) to support rapid sterility testing. The goal is to move product release toward a faster, more standardized process that can help reduce vein-to-vein time and manufacturing burden.

Attend this session to:

  • Understand the Release Challenge: Learn where traditional sterility testing and other operator-dependent assays can create delays in product release, including why sterility testing can take up to 14 days.
  • Explore Rapid Sterility Testing with Sequencing: Examine how next-generation sequencing (NGS) may enable faster detection and identification of microbial contaminants, including bacteria, fungi, and mycoplasma, and support more timely product disposition.
  • Assess the Role of Automation and Integration: Learn how automated release assays can help standardize performance, increase throughput, and shorten analysis times, while supporting future integration with Process Analytical Technology (PAT) and more predictive approaches to product release.

Speakers

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Adriana Geldart Ph.D.

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.

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Michael Giffin, Ph.D.

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.

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Will Arnold, Ph.D.

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.

Register here to watch on-demand!