FAQ: What You Need to Know About How Industry is Tackling CGT Bottlenecks

1. Why is automation critical to industrializing cell and gene therapy (CGT) manufacturing?

Automation is a critical focus in CGT manufacturing and is viewed as necessary to industrialize the process. Industry efforts include consortiums focused on delivering a fully automated robotics CGT manufacturing platform.

2. How much can automation reduce CGT manufacturing timelines?

Through partnerships combining fully automated and digitalized technologies, companies are aiming to reduce CGT manufacturing timelines significantly, potentially to as little as 2.5 days.

3. What strategic manufacturing model supports global CGT scale-up?

Global scale-up requires developing replicable processes that perform consistently across locations. This can be achieved through smart factories that utilize fully automated manufacturing platforms, often referred to as the integrated development and manufacturing organization model.

4. What is the key scalability difference between autologous and allogeneic cell therapies?

Autologous chimeric antigen receptor T cell (CAR-T) therapies are designed to be patient-specific but are time-intensive to produce. In contrast, allogeneic CAR-T therapies deliver scalable, off-the-shelf cancer treatment.

5. Which key raw materials are critical constraints in the CGT supply chain?

To strengthen biopharma supply chains, new facilities are being launched to boost the manufacturing capacity of critical components like plasmid DNA and viral vectors (e.g., adeno-associated virus vectors).

6. How is contamination risk managed during CGT manufacturing?

Contamination is minimized in cell therapy manufacturing by using isolators, following strict staff protocols, utilizing sterile materials, and relying on validated suppliers to ensure the integrity of the process.

7. How do companies prove commercial-scale CGT manufacturing readiness?

Multi-modality Initiative for Certification of Manufacturing Capabilities certification is used to verify manufacturing readiness, confirming that facilities meet US and EU standards for advanced genetic therapies.

8. How are next-generation gene-editing technologies enhancing precision?

Next-generation gene editing platforms are being analyzed for safety and scope. Specifically, new protein-based solutions, such as homology-directed repair enhancers, are designed to improve the precision and accuracy of clustered regularly interspaced short palindromic repeats knock-in workflows in CGT development.

9. Besides technical optimization, what strategic element is crucial for scaling CGTs?

To ensure successful commercial scaling of CGTs, both flexibility and commercial viability must be intentionally built into the development strategy from the early stages.