From Data to Decisions: Using AI to Enhance Manufacturing Efficiency, Consistency & Quality Control

ABOUT THE WEBINAR

This webinar explores how artificial intelligence (AI) is moving from experimentation to operational impact in cell therapy manufacturing, with a focus on machine learning (ML) applications.

Through applied case studies, panelists will show how ML can be used in CAR T and iPSC process development to analyse metabolomics and process data, optimise culture conditions, and improve critical quality attributes.

The session will also highlight how AI-enabled decision-support tools are being integrated into manufacturing workflows to improve process understanding and decision-making, including early signal detection, anomaly identification, and data interpretation within GMP environments.

Attendees will gain insight into practical considerations for implementing AI/ML in cell therapy manufacturing, including regulatory expectations, model trustworthiness, and strategies for integrating AI into existing systems.

Not an ISCT Member? Fill out this form to access the webinar.

KEY LEARNING OBJECTIVES

  • Understand how ML can be applied to metabolomics and process data to improve CAR T and iPSC development
  • Identify how AI/ML improves process understanding, quality attributes, and decision-making
  • Recognize key considerations for integrating AI into GMP manufacturing environments
 WEBINAR CHAIR

Renée Hart, BSc
ISCT PDM Committee Member
President & Chief Business Officer
LumaCyte
United States

Renée Hart is an accomplished operations and business development executive with 25 years of experience across the biopharmaceutical, clinical development & software, healthcare service and bioanalytical instrumentation. Renée brings years of sales leadership and alliance management experience, sitting on multiple executive governance committees and boards across her tenure.  Her collaborative skills backed by strong problem solving and solution management expertise have earned Renée long term trusted relationships resulting in the award and management of significant multi-million-dollar partnerships.

 WEBINAR SPEAKERS

Uma Lakshmipathy , PhD
ISCT PDM Committee Member
Senior Director
Thermo Fisher Scientific
United States

Uma Lakshmipathy is a leader in cell and gene therapy with over 25 years of experience across research, development, translational science, and technical operations. Her work focuses on advancing early scientific discoveries into clinically and commercially viable cell therapy applications through scalable processes, robust analytics, and standardized manufacturing approaches. She has a strong track record of translating emerging technologies into impactful products, platforms, and services. Uma also contributes to the broader scientific community as a trusted advisor, serving on multiple boards for academic, biopharmaceutical, and nonprofit organizations. 

Alex Sargent, PhD
 Director of Process Development 
Charles River Laboratories
United States

Alex Sargent – better known as “Sarge” – is currently the Director of Process Development of Cell and Gene Therapy at Charles River Laboratories. He obtained his PhD from Case Western Reserve University in Cleveland Ohio, where he studied the challenges and promises of stem cell biology, neuroimmunology, and Cleveland sports teams. He then went on to the Lerner Research Institute at the Cleveland Clinic Foundation to continue his research in stem cell biology and neural regeneration. Since joining the biotech industry, he has worked at several large companies on drug discovery and the research and development of groundbreaking cell and gene therapies. These include Lonza Inc., where he patented new technologies for cell therapy manufacturing and CRISPR gene editing, and AstraZeneca, where he worked to bring new chimeric antigen receptor (CAR) T-cell therapies into clinical trials. He is passionate about the challenge of curing cancer, working on cell and gene therapy process and analytical development from discovery, through regulatory submission, manufacturing, and clinical trials. He wakes up each day excited to help advance cell and gene therapy to treat and cure disease, with the steadfast goal of improving human lives.  

Laura Herbst, MSc
 Group Manager 
Fraunhofer-Institute for Production Technology IPT
Germany

Laura Herbst has studied Molecular and Applied Biotechnology at the RWTH Aachen University with a focus on Biochemical Engineering from 2014 to 2020. Since 2020, Ms Herbst is a group manager of the research group “Laboratory Automation” in the department Production Metrology at the Fraunhofer Institute for Production Technology in Aachen, Germany. This group has more than 10 years experience in the field of cell culture automation and is currently developing novel solutions for automated allogeneic and autologous cell therapy manufacturing. Ms Herbst has specific responsibility for process analysis and translation of manual to automated manufacturing. She has a depth of experience working with automation and robotics in the biotech-sector most recently in the EU-funded projects AutoCRAT (Automated Manufacturing of Allogeneic iMSCs) and AIDPATH (Automated Manufacturing of autologous CAR-T cells).