Manufacturability and the Winners in Advanced Therapies
Are developers still underestimating the engineering sophistication required to scale advanced therapies in the real world? Alan Boyd discusses.
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By
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Stephanie Vine
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January 13, 2026
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Clinical Scorecard: Manufacturability and the Winners in Advanced Therapies
At a Glance
| Category | Detail |
|---|
| Condition | |
| Key Mechanisms | Manufacturing challenges and cost reduction in biologics, with emphasis on the shift from discovery to manufacturing. |
| Target Population | |
| Care Setting | |
Key Highlights
- Shift from discovery to manufacturing as the central challenge in drug development
- Emergence of cell and gene therapies as transformative treatments
- Increased focus on reducing costs for wider patient access
- Investment landscape for gene therapies has become more challenging, highlighting funding issues
- Resurgence in development of new chemical entities and traditional chemistry
Guideline-Based Recommendations
Diagnosis
Management
- Implement robust manufacturing processes to ensure scalability and reliability
- Address funding limitations proactively in therapy development
Monitoring & Follow-up
Risks
Patient & Prescribing Data
Gene therapies show promise but face high development costs and limited approvals, impacting patient access.
Clinical Best Practices
- Ensure expertise in manufacturing for cell and gene therapies
- Utilize the 'five Ps' framework for company evaluation in therapy development
- Focus on clear communication of clinical milestones to enhance visibility
- Develop strategies to navigate funding challenges in therapy development
References
