Submission & Analysis
CMC IQ
Manufacturing content · stability program · process validation · for biologics + gene therapy
Active batches
7
under stability monitoring
Stability gaps
3
lots short of 6mo timepoint
CMC Module 3 sections
14 / 18
ready for BLA-HEM-021
Variations YTD
6
2 type IA, 3 type IB, 1 type II
CMC Agent · stability gap analysis
For BLA-HEM-021 (CSL824 gene therapy), Continuum identifies lots V50, V51, V52 missing the 6-month stability timepoint required for the BLA stability table. Lots are in SharePoint/Plant-NJ but not yet indexed into Vault RIM. Cross-system reconciliation recommended.
Stability program — active lots
V47CSL824 AAV vector12mo / 12mo targetOn track
V48CSL824 AAV vector9mo / 12mo targetOn track
V49CSL824 AAV vector6mo / 12mo targetOn track
V50CSL824 AAV vector3mo / 12mo targetInsufficient timepoints
V51CSL824 AAV vector3mo / 12mo targetInsufficient timepoints
V52CSL824 AAV vector1mo / 12mo targetJust initiated
IM-2024-A12IgPro20 plasma pool 2024-A1224mo / 36mo targetOn track