praescia
Product

The unified foresight layer for biopharma manufacturing.

One operating state per batch. One early warning, hours before it’s obvious. Every driver named. Every advisory explainable, auditable, and on the record.

What Praescia does

Praescia ingests from every system your manufacturing site already runs — process historians, in-line sensors, MES batch records, LIMS, environmental monitoring — reasons across sources through the Biopharma State Spine, and produces:

  1. A live operating state for each batch run — on-trajectory, drifting, transitioning, at-risk. Calibrated, debounced, explainable.
  2. An early advisory with named drivers: what signal, what threshold, what trajectory.
  3. A quantified risk band — predicted titer / yield / OOS-risk, called pre-harvest.
  4. A cross-source unified picture — the conclusion no single historian or PAT tool could have reached alone.

The seven-stage Biopharma State Spine

Every advisory travels the same seven-stage pipeline — adapted from the proven Atlas family and re-skinned for bioprocess vocabulary.

Stage 1

OBSERVE

Ingest historian, in-line sensor, MES, LIMS, and EM feeds from every source the site already runs.

Stage 2

NORMALIZE

Unify signals, resolve batch identity, align timestamps, validate data integrity (ALCOA+).

Stage 3

DETECT_STATE

Interpret the live batch state: culture phase, golden-trajectory alignment, constraint state on the line.

Stage 4

DETECT_TRANSITION

Detect onset of deviation, bottleneck, or excursion. Debounce against noise. Surface only real transitions.

Stage 5

ESTIMATE_OUTCOME

Project titer / yield / batch-success probability and release timing — called early, not at the assay.

Stage 6

RECOMMEND

Synthesize into one explainable advisory per decision — with named drivers and the required human disposition.

Stage 7

VALIDATE

Deterministic replay, precision/recall metrics, and audit-trail generation. Every advisory is replayable.

The Biopharma Combining Layer

The genuinely new IP. Ten sub-modules operating over a typed manufacturing knowledge graph.

The Combining Layer produces conclusions no single historian or PAT tool can reach. The typed knowledge graph spans Batch · BioreactorRun · ProcessPhase · Signal · GoldenTrajectory · Deviation · Advisory · Disposition · Equipment · Line · Utility · CleanroomEvent · ColdChainLeg · TechTransferEvent · ValidationRecord · AuditEntry.

Identity resolution

Batch B1234 in the historian = Batch B1234 in MES = Batch B1234 in LIMS. One canonical record per run.

Golden-trajectory learning

Fit the golden trajectory from real good batches (LearnedGolden). Residualize each live run against it to handle non-stationarity.

State fusion

Merge per-engine state estimates (Atlas PC + Atlas OI) into one authoritative batch state.

Signal fusion

Cross-signal correlation: pH × DO × biomass × metabolites × feed rate — the combination that a single-signal threshold misses.

Timeline fusion

Chronological merge across historian, MES event log, and LIMS sample pull. Source lineage preserved.

Risk fusion

Merge per-engine risk signals into one risk band (low / elevated / high / critical). One number for QA to act on.

Cross-site benchmarking

Fleet-level golden-trajectory comparison across lines and sites. Appears as the network grows (density tier).

Contradiction detection

Contradictions across data sources flagged and escalated before they become a batch-record finding.

Unified recommender

One advisory per decision. Named drivers. Named disposition path. No ambiguity about what to do next.

Replay engine

Every advisory is deterministically replayable. Run it again on the same data and get the same result. Audit-ready.

Three posture invariants — present at every layer

Insight-only. Praescia advises. It never touches the process equipment, the MES recipe, or the SCADA controller. Every action is human-approved. Permanent, not a phase.

Validation-ready by design. 21 CFR Part 11 / EU Annex 11 / GAMP 5 / ALCOA+ is built in, not bolted on. The audit trail, e-signatures, and data-integrity controls ship with the product. We lower your CSV burden.

Explainable, not a black box. Every advisory carries named signal drivers and a reason code. Defensible in a deviation investigation, to QA, and to a regulatory reviewer. No opaque model outputs.

What Praescia does NOT do

Posture, not roadmap:

  • Control the process. Praescia is insight-only. It reads historian and sensor data, advises the operator, and stops there. The SCADA and DCS remain sovereign.
  • Replace your MES or LIMS. Werum PAS-X, LabVantage, STARLIMS, Tulip — these are consumed as sources. Not replaced, not replicated.
  • Replace PAT instruments. METTLER TOLEDO, in-line Raman, soft sensors are read as plugins. Praescia adds the layer above them.
  • Act autonomously. Every advisory requires human disposition. This is the regulatory moat, not a limitation to engineer away.
  • Certify your process. Praescia supports validation; it does not issue regulatory approvals or act as a notified body.