Bridging Next‑Generation Capsid Innovation and Manufacturability: Aligning Research and CMC for Clinical Readiness
04 May 2026
Next Gen Vector Engineering & Delivery
- How can research and CMC teams collaborate from the earliest stages of capsid discovery to ensure that machine‑learning–designed, receptor‑targeted or immune‑evading capsids—engineered to improve on‑target delivery and reduce vector dose requirements—are also manufacturable at scale?
- Given that unforeseen formulation and stability issues cause substantial delays and more than a third of clinical holds stem from CMC deficiencies, at what point in capsid discovery should CMC experts be “at the table” to de‑risk new capsids and avoid late‑stage development hurdles?
- Which critical quality attributes and biophysical properties (such as full/empty capsid ratios, aggregation, genome stability and potency) must be characterized early so that the transition from bench to clinical manufacturing does not become a bottleneck?
- With viral vector manufacturing lacking a standardized, off‑the‑shelf platform and companies relying on different production systems, how can platform selection and process design be integrated into capsid discovery to ensure that novel vectors can be produced consistently and meet regulatory expectations?
- What role can predictive modeling, AI‑guided formulation and design‑of‑experiments strategies play in predicting developability, optimizing stability and enabling faster IND submissions for next‑generation capsids?
