A good cell and gene therapy (CGT) manufacturing roadmap provides flexible guidelines to advance automation. It’s a living document and will be refined many times as cell therapy manufacturing needs and processes evolve.
Guide: Transition Clinical CT Manufacturing to Commercial Scale
The roadmap should first be implemented during the preclinical phase to encompass the complete journey. The destination is full commercialization, and each manufacturer must understand how to get there.
CGT manufacturers must review the technology landscape to understand their choices. For example, they may need an instrument that does not actually exist and will have to decide whether it is more cost-effective to build one from scratch or find another option.
The key is mapping out the entire manufacturing process and developing a clear understanding of what needs to be done and when.
Key questions to ask when building a manufacturing roadmap:
1. Requirements and scope
What scale does the project need to reach and when?
What kinds of automation exists now and what will be needed to make the project successful?
What are the variabilities in the current process, and how can they be mitigated?
What are the current manufacturing costs?
2. Technology assessment and prototyping
What happens now, in 12 months, in 24?
Are suitable platforms available and can they be integrated into the control system architecture?
How much time and money will be needed to acquire these systems, and what is their impact on overall efficiency and cost?
What are the key risks associated with automation, and how will these be mitigated?
3. Process finalization, platform build and testing
When the new automated system is tested in the lab, is the biology still sound?
Will this manufacturing approach work at high volume?
4. Installation and commissioning
Are all operators fully trained on the new processes and platforms?
Does production data fully satisfy quality assurance and regulatory agency requirements?
Understanding short and long-term manufacturing requirements upfront is vital – it enables CGT manufacturers to plan. By mapping out the entire development process, manufacturers will be better enabled to construct a powerful roadmap, advance automation and scale their manufacturing.
Jon is the San Diego Cell Therapy Manager, responsible for the Invetech applications science team. He has almost 20 years cell therapy experience, initially in cord blood banking and transplantation in the UK National Health Service, before moving into industry in the U.S. and developing novel cell isolation and selection technologies.