Objective:
To discuss the challenges and strategies in scaling manufacturing for advanced therapies in the pharmaceutical industry.
Key Findings:
- The science of advanced therapies has outpaced the existing manufacturing infrastructure.
- Speed to clinic is a competitive imperative, necessitating faster facility development.
- Modular manufacturing offers a strategic advantage by allowing for reconfiguration and reduced capital risk.
Interpretation:
Limitations:
- The regulatory environment is complex and evolving, adding uncertainty to capital commitments.
- Emerging markets face a more acute infrastructure challenge due to a lack of existing ecosystem support.
Conclusion:
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