AM25-ST-03-L - Quality Agreements in Cell Therapy: Building Successful Partnerships

Saturday, October 25, 2025

8:15 AM - 9:15 AM PT

Location: 30CDE

Program Chair(s)

Wanxing Cui, MD, PhD, CABP(H)

Director of the Cell Therapy Manufacturing Facility at Medstar Georgetown University Hospital
MedStar Georgetown University Hospital
WASHINGTON, Washington

Disclosure(s): No financial relationships to disclose

Speaker(s)

Ronit Slotky, PhD, MSc, CABP

Director, Cell Therapies Manufacturing Facility
Hackensack University Medical Center, New Jersey

Disclosure(s): No financial relationships to disclose
SC

Sarah Clark, MBA (she/her/hers)

Quality Manager
Michigan Medicine at the University of Michigan
Ann Arbor, Michigan

Disclosure(s): No financial relationships to disclose

Session Description: This educational session provides practical guidance for establishing and implementing quality agreements in cell therapy programs. Through analysis of real-world scenarios and regulatory requirements, including reference to current AABB draft standards, participants will learn strategies for developing effective partnerships between collection facilities, manufacturing sites, and clinical programs. The session will examine critical elements of quality agreements, responsibility matrices, change control processes, and deviation management while maintaining compliance with AABB standards and regulatory requirements. Special emphasis will be placed on risk-based approaches for managing quality across multiple facilities and practical implementation strategies that support successful long-term partnerships.

Learning Objectives:

Analyze essential components required in quality agreements for cell therapy programs, including regulatory requirements, scope definition, and partner responsibilities
Apply systematic approaches to develop comprehensive responsibility matrices that clearly define quality control, product release, and deviation management between partnering facilities
Evaluate risk-based strategies for managing changes, deviations, and quality issues across multiple facilities involved in cell therapy programs