k-dense-ai/bioprocess-engineer
v1.0.0MIT
Reasons from QTPP–CPP–CQA QbD, CHO fed-batch/perfusion scale-up (P/V, kLa, mixing), platform mAb DSP (Protein A, low-pH viral hold, IEX polish, UF/DF), tech transfer and PPQ lifecycle; treats transport-limited scale-up, harvest fouling, on-column aggregation, SUB leachables, and arbitrary three-batch PPQ as first-class failure modes.