Stop transferring a description. Transfer the process.

Vektor turns a biomanufacturing process into a computable model — design space, equipment sensitivity, failure history — so the receiving site can interrogate it before the first GMP batch.

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Process Model · ID-114 · site B → contract site 7

Model the transfer of ID-114, a 2,000 L fed-batch mAb, from Site B (stainless) to Contract Site 7 (single-use). Tell me where it breaks before we book an engineering run.

@corpus Reads 412 batch records, 87 deviation investigations, 14 CAPAs and 9 method transfer reports from the Site B archive.

@designspace Reconstructs critical process parameters as operated, not as filed — and locates the real edge of the design space from where the process has already failed.

@facilityfit Maps the equipment delta — kLa, tip speed, hold volume, capture skid — and separates genuinely scale-dependent steps from ones that merely look risky.

@comparability Ranks which quality attributes are most likely to drift under this specific scale and equipment change, scoping the ICH Q5E protocol before batches are burned.

Transfer risk forecast complete — 3 high-risk unit operations · first-batch success 61% (±9) · 2 engineering runs expected · 47 provenance links

Sponsor view Receiving site ICH Q5E Ask the model…

The problem

Around half of technology transfers hit quality problems, and moving to an external site adds close to six months — because the thing that actually makes the process work was never in the package.

How it works

The process,
made computable.

A biological process is held together by a handful of people who know that the feed must start before the culture reaches a particular density, and that the deviation logged in batch 214 was the moment everyone learned where the real edge sits. Vektor reads the record that already exists, builds a provenance-linked model of the process, and forecasts what the receiving site will encounter.

Give us a transfer that failed

Ingest · site B archiveParsed

development reports38 ✓

batch records412 ✓

deviation investigations87 ✓

CAPAs14 ✓

method transfer reports9 ✓

historian traces2.1M pts

Read the record, not the room

Every deviation is an experiment the process ran on itself, at its own edges, and then filed away. Four hundred of them are a map of where the process actually breaks — and no human has ever read all four hundred and asked what they collectively imply.

Unit op 04 · production bioreactorModelled

pH setpoint6.95

filed / observed6.80–7.20 / 6.90–7.02

dissolved O₂40 % scale-dep.

feed triggerVCD 8.2e6/mL

temp shiftd5 · 36.5→33.0 °C

provenanceBR-2214 · DEV-0087

Build the Process Model

Unit operations and topology, critical process parameters at their real operating ranges rather than their filed ones, parameter interactions, scale-sensitive steps and observed failure modes — every assertion linked back to the batch, document or dataset it came from.

Design space · unit op 04Outside

Forecast before you commit

A dated, quantified projection produced before the transfer is committed: probability of first-batch success, expected engineering runs, likely deviation categories, and where the receiving site's predicted operating point falls outside the design space. A range with confidence attached, not a Gantt chart drawn by optimism.

What we believe

A process is not a document. It is a system with a design space, scale-dependent behaviour, parameter interactions and a failure history — and all of it is computable.

Capabilities

What the
model answers.

Incumbent software manages the administration of a transfer: documents, tasks, approvals. It answers whether the paperwork is complete. Vektor answers whether the process will actually run at the new site — and it keeps answering after the transfer report is signed.

How your data is handled

Equipment delta · B → 73 flagged

vessel2,000 L SS → SU

kLa18 → 12 h⁻¹ ▲

tip speed1.4 → 1.9 m/s ▲

pool 2 hold8 → 26 h ▲

capture skid400 → 800 ○

buffer prepin-line → batch ○

Facility fit and scale translation

The receiving site has different bioreactor geometry, different mixing and oxygen transfer, different hold capability, different single-use versus stainless configuration. Vektor models how critical parameters shift under those specific deltas and returns a ranked list of where this transfer will break.

Predicted drift · ICH Q5EScoped

afucosylationHigh

HMW speciesElev.

charge variantsMod.

potencyLow

host cell proteinLow

→ protocol scoped to 3 attributesnot 11

Comparability, pre-computed

Comparability under ICH Q5E is one of the largest time sinks in a transfer. Vektor predicts which quality attributes are most likely to drift given this specific equipment and scale change, so the protocol is designed against the real risks instead of against everything.

MSAT · contract site 7Live

> why is pool 2 hold flagged? Three Site B deviations involved an extended pool-2 hold. HMW rose 0.4–0.9 % each time. Site 7's schedule implies 26 h. sources · DEV-0041, DEV-0062, DEV-0079 > what would clear it? Hold under 12 h, or an in-process HMW check before load.

A model that keeps learning

The model does not close out with the transfer report. It keeps learning from commercial production at the receiving site, which means the next transfer of that process starts from a far richer model and the site's process understanding compounds instead of dispersing.

What you get

Built for the way this industry has to work.

Provenance, not assertion

Every output links to the batch record, dataset or deviation it came from. In a GxP environment an assertion without a source is worthless, so the model never produces one.

Decision support, not a system of record

Vektor does not release batches, replace the batch record or make quality decisions. Outputs are reviewed and approved through your existing quality system, exactly as an internal assessment would be.

GAMP 5 and Part 11 by design

Designed for GAMP 5 categorisation with 21 CFR Part 11 controls and a full audit trail. Where a Process Model informs a submission it does so as documented rationale supporting a human-authored argument.

Learns across transfers, not across your data

The archetype library is built from process topology and equipment characteristics, never molecule identity. There is a hard architectural line between your process data and anything shared.

Founder

Saksham Jain

Founder

The record was
always there.

Saksham Jain founded Vektor on a single conviction: the knowledge that makes a manufacturing process work is not truly tacit. It is simply unread. It sits in deviation investigations, CAPAs and batch histories written under regulatory obligation, filed once, and never examined as a set.

Vektor exists to read that record at scale and turn it into something a receiving site can interrogate — a model of the process rather than a description of it. The entry engagement is deliberately falsifiable: give us a transfer that already failed, and we will tell you what we would have predicted before it started.

Every transfer that failed was investigated. The answer was written down, approved and filed. Nobody had a way to read four hundred of them at once.

founder@vektor.bond LinkedIn

Trust & data

Deviation files are the most sensitive documents in the building.

They are treated that way. Single-tenant deployment where it is required, customer-managed encryption keys, role-based access scoped to the program, and a hard architectural line between your process data and the shared archetype library. No cross-customer model training without explicit contractual opt-in — and the entry engagement is a fixed-fee retrospective on a transfer you have already completed, so nothing forward-looking is committed before the model has proved itself against your own history.

21 CFR Part 11 GAMP 5 categorised Single-tenant option Customer-managed keys RBAC by program Full audit trail Provenance-linked outputs No cross-customer training

Data boundaryEnforced

process datacustomer tenant

deviation corpuscustomer tenant

molecule identitynever shared

process topologyopt-in only

equipment classopt-in only

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Get started

Give us a transferthat already failed.

We will produce the risk forecast we would have produced before it started, and you can compare it to what actually happened.

Book a demo founder@vektor.bond