Define the climb before the team leaves base camp.
Plan is where every Summit program is shaped — the molecule scrutinised, the quality attributes argued, the control strategy built, and the Plan of Action prepared. Risk doesn't get added later. It's modelled from the first sequence.
Liability assessment
Find every liability in the molecule before the molecule finds you.
Summit Insights can read heavy and light chain variable-region sequences, identify CDRs, and surface sequence-based liabilities that drive CMC risk — including deamidation, isomerization, oxidation, glycosylation motifs, aggregation flags, and immunogenicity indicators. Every finding shown here is mapped to a specific Kabat-numbered residue and tied to a CQA concern.
- Current view is intentionally scoped to VH/VL variable domains
- CDR hotspots are annotated with Kabat numbering and liability mechanism
- Findings connect to CQA concerns that can feed the program risk register
- Constant-region and full-structure assessments remain separate app surfaces
VH variable domain
120 aa · Kabat
VL variable domain
107 aa · Kabat
Asparagine deamidation
Trastuzumab HCDR2 contains an N-G motif at Kabat H:Asn55, a classic deamidation hotspot that can form acidic variants under stress.
CQA concern: Charge variants · Potency / target binding
One liability finding. Every downstream surface updated automatically.
Automatic risk amplification
One finding ripples through the whole program — without anyone re-keying it.
A liability isn't just a row in a spreadsheet. Summit propagates it: into the affected CQAs, the CPPs that drive them, the activities needed to control them, and the timeline impact that follows. The Plan of Action reshapes itself, with every change attributable to its source.
- Liabilities auto-bind to CQAs via mechanism mapping
- CQAs amplify into the CPPs and unit operations that govern them
- Activities are added, extended, or flagged based on residual risk
- Risk register, scoring, and timeline are kept in lockstep — always
Everything else in Plan
The rest of the design phase, in one workflow.
CQA Identification
Liability bucketing into Critical Quality Attributes with proposed criticality and acceptance criteria.
CPP-CQA Coverage Map
See which CPPs actually drive each CQA — and where the control strategy is exposed.
Risk Register
Every program risk in one place — scored, owned, and linked to the activities that mitigate it.
Program Timeline Builder
Compose timelines from a structured catalog of CMC activities. Re-sequence in minutes.
Plan of Action
The signed, governance-ready output of Plan — ready to be promoted to execution.
Vulnerability Map
A connected view of where each program's quality risk actually sits, before clinic.
Plan it once. Defend it for the life of the program.
See how Plan would model one of your own programs in a 30-minute working session.