Tech Transfer and Scale-Up for a CAR-T Manufacturing Program
CLIENT OVERVIEW
A next generation CAR-T therapy company transitioning from an academic manufacturing process to a commercial capable CDMO platform.
CLIENT CHALLENGE
Documentation varied across academic groups, equipment decisions were pending, and the CDMO required clearer process definition. Timelines for engineering batches were aggressive.
PIONEER ENGAGEMENT
Created a complete tech transfer package from fragmented academic documents
Developed process maps, material lists, equipment strategy, and risk assessments
Supported CDMO evaluation and selection with capability benchmarking
Led on-site transfer activities and documentation creation
Developed validation strategy and PPQ roadmap
Trained CDMO staff to ensure consistent process execution
KEY DELIVERABLES
Tech Transfer Plan
Process maps and risk assessments
Equipment and material lists
CDMO scoring model
Validation and PPQ strategy
OUTCOME
Engineering batches executed successfully and on schedule. The CDMO demonstrated strong process understanding and alignment with long-term manufacturing objectives.
