Advancing Cell Therapy Development with Integrated Analytical and Process Strategies

Biotech, Cell and Gene Therapy, Drug Discovery & Development, Life Science, Pharma,
  • Tuesday, November 11, 2025 | 11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)
  • 60 min

Analytical and process development (PD/AD) strategies directly impact how quickly and reliably cell therapies reach patients. Join this webinar to explore integrated PD/AD expertise that delivers robust, regulatory-ready assays and accelerates cell therapy development.

The featured speakers will share case studies on rapid potency assay creation for AAV and mRNA products, along with additional optimized and transferable solutions.

Attendees will join a live poll on PD/AD challenges, with results discussed in real time.

The session will showcase standalone analytical services, including potency assay development, flow cytometry modules and cell therapy assay platforms.

Register for this webinar to learn how integrated PD/AD strategies can accelerate cell therapy development through regulatory-ready assays.

Speakers

Patrick Kellish, Kincell Bio

Patrick Kellish, PhD, Senior Scientist, Analytical Development, Kincell Bio

Patrick Kellish, PhD, is a Senior Scientist in Analytical Development at Kincell Bio, a cell therapy CDMO with facilities in North Carolina and Florida. In his current role, Dr. Kellish leads analytical development efforts that support cell therapy programs from early-stage process development through clinical supply manufacturing. His work focuses on designing and qualifying critical assays for cell identity, potency and safety to ensure robust product characterization and regulatory readiness.

Before joining Kincell Bio, Dr. Kellish served as a faculty member at the University of Florida, where he was Director of the flow cytometry core. In that role, he led immune monitoring initiatives supporting early-phase clinical trials. Specializing in early phase cell therapy production and characterization, his background includes the immunology of viral vectors, oncolytic virotherapy and cell therapies for solid tumors and hematological malignancies. His expertise bridges discovery research and translational development, with a focus on enabling the clinical advancement of novel therapeutic platforms.

Message Presenter
Douglas Mogensen, Kincell Bio

Douglas Mogensen, VP, Commercial Development, Kincell Bio

Douglas Mogensen is Vice President of Commercial Development at Kincell Bio, where he leads commercial strategy and business development, working with clients to align Kincell’s technical capabilities with the evolving needs of advanced therapy programs. His focus is on building partnerships that support cell and gene therapy innovators from early clinical development through commercial launch.

Before joining Kincell Bio, Douglas served as Vice President of Global Business Development at Bionova (an Asahi Kasei company), where he led the global commercial organization and helped commercially launch their first plasmid facility, a key capability supporting the growth of advanced therapies. He also held senior commercial roles at Catalent Pharma Solutions, where he led business development efforts across biologics, analytical services and nucleic acid therapeutics. Over his career, Douglas has developed expertise in bridging scientific, technical and commercial functions, helping biopharma organizations bring complex therapies to market. His background includes roles in diagnostics, high-throughput automation and biologics development, giving him a broad perspective across the biopharmaceutical value chain.

Message Presenter

Who Should Attend?

This webinar will appeal to:

  • Technical leaders (CTOs, VPs, Directors)
  • Scientists in Analytical Development (AD), Process Development (PD) and Chemistry, Manufacturing and Controls (CMC)
  • CMC consultants seeking to streamline analytical development and deliver robust, fit-for-purpose assays that can scale as programs progress through clinical development

What You Will Learn

Attendees will:

  • Explore approaches to developing and implementing proliferation, AAV/mRNA potency, cell killing and flow cytometry assays in cell therapy development
  • Learn how PD/AD workflows can rapidly generate “fit-for-purpose ” testing to support small-scale PD work on accelerated timelines
  • Gain insight into how emerging technologies are being applied in cell therapy PD/AD

Xtalks Partner

Kincell Bio

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK and CAR-M programs, as well as developing expertise in stem cell products and iPSCs. For more information, visit www.kincellbio.com.

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