Bodhi is a compact, self-contained incubator platform for adherent AAV manufacturing that integrates AI-powered brightfield/fluorescence microscopy, programmable microenvironments, closed sterile fluidics, and an electronic batch record.
Preserve workflow continuity. Standard off-the-shelf roller bottles; no proprietary consumables that lock users in or raise per-run cost.
Close the loop around the biology. HEPA filtration, sterile quick-connects, UV/chemical sanitation, and positive-pressure differentials to keep contamination risk low.
Put AI in service of the operator. Confluence and transfection quantification with uncertainty estimates, not black-box automation.
Make every run auditable. Immutable, hash-verified batch records designed to survive tech transfer and satisfy downstream quality systems.
Architecture, enclosure and sterile fluidics, independent lanes, roller-bottle and port-cap spec, environmental verification, and head-to-head comparability against open-bench 2D.
Targets: 0 CFU sterility across ≥5 runs · ±0.2 °C, ±0.2% CO₂, ±2% RH over 72 h · yield parity ±20% vs. open-bench 2D · <10 min/day operator time per active lane.
Imaging hardware, NIST-traceable calibration, segmentation and transfection-positivity modelling, human-factors UI, integration with an immutable electronic batch record.
Targets: confluence MAE ≤5 pp · transfection absolute error ≤10 pp · repeatability CV ≤5% · analytics latency ≤30 s/field · SUS ≥80.
Avagene operates under ISO-aligned design controls and software lifecycle discipline, with a design history file (DHF), device and product master records (DMR/PMR), and configuration-controlled changes across hardware, firmware, and AI models.
Acceptance thresholds are predefined. Blinded raters annotate confluence. Cross-day and cross-instrument repeats are run at n ≥ 3 per condition. Independent replication is performed at Temple under subaward. Daily microscope calibration checks, mycoplasma PCR before each campaign, and qPCR vector-genome titers on every harvest back the reference data.
A 3-roller-bottle prototype in a repurposed incubator yielded greater than 1 mL of high-titer AAV. Three runs established even cell distribution and vibration-assisted lysis. In vivo rat brain transduction was achieved in collaboration with the Temple Shriners Pediatric Research Center.