Developing a Robust Platform Process for Manufacturing Novel Capsids
- Investigating differences in manufacturability caused by AAV capsid modification.
- Discussing techniques to maintain process robustness across diverse capsids and payloads.
- Highlighting Affinia’s use of single-use clarification, affinity purification and ultracentrifugation to achieve full capsid enrichment to ensure batch consistency and regulatory confidence
- Presenting lessons from the transfer of AFTX-201 high yield process to a CDMO partner, including reproducibility of yield and capsid quality across sites