Beyond the Starting Material: Building a Path to GMP Manufacturing Success

For cell therapy developers, manufacturing success starts well before a process enters a GMP cleanroom. Decisions around donor and material sourcing, collection strategy, starting material specifications, process development, and analytical strategy can directly influence process consistency, technology transfer, and manufacturing readiness.

Join technical experts from New York Blood Center Enterprises’ Comprehensive Cell Solutions (CCS) team for a practical discussion on connecting cellular starting materials with downstream process development and GMP manufacturing. Drawing on real-world experience across sourcing, collections, process and analytical development, technology transfer, and clinical manufacturing, the panel will highlight key considerations and common challenges that arise as programs move from early development toward the clinic through commercialization.

The discussion will explore how teams can better align starting material requirements with the manufacturing process, establish appropriate controls and specifications, prepare processes for successful technology transfer, and build a more reliable path into GMP manufacturing. Attendees will leave with practical considerations for reducing variability, anticipating manufacturing challenges, and making development decisions with later-stage requirements in mind.

Key Learning Objectives

• Understand the role of starting material in process performance and how donor criteria, collection strategy, material attributes, and variability should be considered during development
• Identify key considerations when moving a process into GMP manufacturing, including process and analytical readiness, technology transfer, facility fit, and operational execution
• Learn how early development decisions can support later-stage manufacturing, helping teams anticipate risks, improve process robustness, and prepare for clinical and commercial requirements