As the cell and gene therapy field progresses and the number of product approvals continues to grow, there is an increasing demand to incorporate higher-volume production to deliver potentially life-saving therapies to expanding patient populations.
Alliance for Regenerative Medicine’s white paper examines the current state of cell and gene therapy manufacturing and analyzes key strategies – including automation, AI/ML and decentralization – to overcome barriers to wider patient access.
We’ve summarized the key takeaways from the report…
- The core challenges
With more approvals and expanding patient populations, traditional manufacturing methods can’t meet the soaring demand:
- Logistical complexities make short therapy shelf-lives a race against time.
- High costs – stemming from manual, labor-intensive processes – drain resources.
- Limited throughput means centralized systems struggle to scale efficiently.
- Regulatory hurdles, with outdated guidelines, continue to slow innovation.
- Automation can alleviate some of the challenges
Automation can be applied at various levels, including modular, semi-automated, and fully automated systems, to boost productivity:
- Predictive models simulate process changes, avoiding costly errors.
- Real-time monitoring automates adjustments, boosting efficiency.
- Demand forecasting ensures optimal resource use, cutting waste and delays.
- Decentralized manufacturing can bring therapy production closer to patients and improve accessibility.
- The regulatory landscape is catching up
In May, the FDA released Draft Guidance to streamline drug development, manufacturing and review. Key regulatory considerations include:
- The IND sponsor remains accountable for all aspects of manufacturing, regardless of the location.
- A central site is expected to oversee all decentralized facilities and ensure product release consistency.
- Demonstrating comparability between different manufacturing sites is crucial for ensuring product quality and regulatory compliance.
- The future for advanced manufacturing
The industry must embrace innovation and collaboration to overcome manufacturing challenges and ensure wider patient access. Key focus areas will likely include:
- Developing robust and flexible manufacturing platforms.
- Improving data infrastructure and analytics capabilities.
- Fostering a skilled and adaptable workforce.
- Engaging with regulatory agencies to shape clear guidelines and facilitate innovation.
Download the full report.