Visible Particulates in Cell and Gene Therapy: Challenges and Perspectives in Risk Assessment

ABOUT THE WEBINAR

Join us on November 13, for a webinar from the ISCT Process Development & Manufacturing Committee, on "Visible Particulates in Cell and Gene Therapy: Challenges and Perspectives in Risk Assessment." This session, sponsored by Gateway Analytical, seeks to explore the unique challenges posed by visible particulates in low-unit cell and gene therapy (CGT) batches. As regulatory concerns mount and traditional standards fall short, our expert panel will share insights from various stakeholders, including manufacturers, service providers, and regulatory consultants. Discover the operational impacts of lot rejection, learn about best practices for managing particulate risk, and delve into regulatory expectations. 

This webinar will focus on practical strategies and best practices while providing actionable approaches for managing visible particulates. Participants will gain valuable insights into navigating these challenges in their work, ultimately leading to improved outcomes in cell and gene therapy manufacturing. Join us to engage with industry leaders, identify knowledge gaps, and contribute to a dialogue that prioritizes patient safety while addressing the complexities of CGT manufacturing. Don't miss this opportunity to be part of an essential conversation shaping the future of cell and gene therapy quality standards!

ACCESS THE RECORDING NOW

KEY LEARNING OBJECTIVES

  • Understanding the misalignment between traditional particulate standards and the realities of cell and gene therapies (CGT).
  • Discover how manufacturers, service providers and regulators tackle particulate challenges in their respective roles. 
  • Gain practical insights from service providers experienced in managing particulates in real-world settings.
  • Explore regulatory precedents that allow for tolerance of particulate risks in other high-stakes contexts. 
  • Identify significant knowledge gaps and recognize necessity for structured, CGT-specific approaches and solutions. 
 WEBINAR CHAIR

Antonio Scatena, BSc
ISCT Manufacturing Materials Safety and Technology Working Group Co-Chair
Director of Sales and Marketing
Gateway Analytical
United States

Antonia Scatena is a member of the leadership team at Gateway Analytical, where he specializes in analytical testing for parenteral packaging and drug delivery systems. He partners with pharmaceutical and biotechnology companies to proactively address regulatory expectations and prevent compliance gaps during critical stages of development and commercialization. With expertise in container closure integrity, extractables and leachables, and particulate matter characterization, Antonio operates at the intersection of science and regulation to provide defensible data packages tailored for agency review and approval.

 WEBINAR SPEAKERS

Barbara Ressler, PhD
 VP, Manufacturing Process Sciences
RoslinCT
United States

Dr. Ressler is the Vice President of Manufacturing Process Sciences at RoslinCT United States, where she leads the Analytical Development and Process Development team to deliver robust, GMP-compliant processes and assays for cell and gene therapy products. With leadership roles at Mustang Bio, Editas Medicine, Duke University, Dr. Ressler has advanced multiple CGT products into clinical trials and contributed to three licensed therapies, including the successful BLA for RETHYMIC®. She is deeply committed to building high-quality data sets that drive decision-making and deepen product understanding. Dr. Ressler entered the CGT field when there was only one FDA-approved product available and continued to shape the industry's growth. She holds a B.S. (BSc) in Biomedical Engineering from Northwestern University and both an S.M. and PhD in Mechanical Engineering from MIT.

Donnie Beers, BSc
Life Sciences Applications Leader - CGT
Entegris, Inc.
United States

Donnie Beers, Life Sciences Applications Leader for Entegris, Inc., has held many roles in process science and bioproduction over the last two decades, and brings a wealth of collaboration and leadership experience gained during his past process sciences and commercial roles. Donnie joined Entegris in 2019 as Sr. Product Manager for single-use products and has since taken a lead role in helping customers overcome unique challenges in cell and gene therapies, leveraging his prior work in developing, implementing, and commercializing single-use and automation technology in biopharma. Donnie earned his BSc in biochemistry from the University of Wisconsin - Madison. 

Heath Coats, MS
 Senior Principal, Head of Quality & Compliance
Dark Horse Consulting Group
United States

Heath Coats brings over 35 years of industry and consulting experience in biologics and cell therapy, including seven years as a Biologist at the FDA's Center for Biologics Evaluation and Research (CBER). At the FDA, he performed regulatory reviews and led inspections for a wide range of products, including cell therapies, vaccines, and in vitro diagnostics, gaining deep expertise in GMP compliance and CMC regulatory strategy. Heath has conducted numerous pre-license and pre-approval inspections, advised sponsors on facility design and manufacturing practices, and supported regulatory submissions. Before his tenure at FDA, he managed validation programs at a contract manufacturing firm, overseeing facility, equipment and process validation. With a strong foundation in biologics manufacturing and regulatory affairs, Heath now supports clients through facility reviews, audits, inspection readiness and strategic regulatory consulting.