The technology transfer package, built from your development records — every gap found and decided before a batch is at stake
Every transfer package built from the development records in days, with each gap found and decided before a batch is at stake.
See one case, screen by screen ↓A transfer package is built from records that were never written for the receiving site: development reports, executed batch records, the process FMEA, method documents and two equipment lists. Someone in MS&T has to read them all, copy every set point and range into tables, and work out what changes at the new scale — a 200 L pilot process going to a 2,000 L single-use bioreactor at another plant, or a tablet process going to a CDMO.
The hard gaps are not the missing documents. They are the ones hidden between sources: a hold time that is 48 h in the batch record and 72 h in a newer study, an FMEA that credits a Raman probe the receiving site does not have, a parameter nobody varied at small scale that will behave differently in a bigger vessel. Found late, they can turn into a failed engineering run or a deviation at PPQ.
Estimated split, in working days from kick-off to a complete package draft, by hand and with the solution. Deciding gaps can take a little longer, because more of them are found before the run.
Six agents read the records, check the package against the transfer checklist and write every gap; the transfer lead decides each one.
Veltrimab drug substance is moving from Process Development in Cambridge, MA to Plant 3 in Leiden — 200 L to 2,000 L single-use — with engineering run 1 booked for Nov 16. A new hold-time study has just arrived. Here is what happens next, screen by screen, in the working solution.
Lena opens the solution to nine transfers in motion across four of her company’s plants and three CDMOs: 45 open gaps, 39 of them blocking a start, and 23 waiting for her decision. The departures board lists the next milestones, and the first item under Needs you is new.
“3 new documents for Veltrimab → Leiden — Hold-time study arrived Oct 6 · run the gap check.”
The transfer sits in the Protocol phase. Against the Biologics drug substance v4 checklist, 32 items are found, 7 partial, 5 missing and 2 not applicable, backed by 43 source documents. A banner lists what has arrived since the last check on Oct 2: the hold-time study DR-VLT-0451, Leiden’s equipment list rev 2 and the buffer hold-time study BHT-VLT-04.
The Document reader reads the three new documents, bringing the package to 46. The Parameter extractor re-reads 212 parameters and flags one: the neutralised pool hold, where two sources disagree, 48 h against 72 h. The Equipment fit analyst recomputes Leiden against Cambridge, the Checklist checker runs all 46 items, and the Gap writer writes up what changed.
Each step shows what it found and how long it took — 1.9 s to read the new documents, 2.0 s to re-read the parameters.
Readiness drops from 81 % to 78 %. Checklist item G1, In-process hold times — “Supported hold times for every intermediate” — is now marked two sources disagree. The new gap, G-2611-03, says where each value came from and that the study notes the batch record has not yet been updated.
“1 new gap written for you to decide.”
The batch record MBR-VLT-DS-200 v5.2 says to hold the neutralised pool at 2–8 °C for not more than 48 h. The new study supports 72 h, with HMW up by only 0.1 %. Lena picks the recommended option — 48 h as the operating limit, 72 h as the proven limit — and her reason goes on the audit trail with the decision.
“The Parameter extractor found two values for this limit. Agents never pick one — you decide which transfers.”
Ten aspects compared: 4 fit, 3 need an adjusted setting, 3 are gaps. Matching 20 W/m³ in the 2,000 L bioreactor needs about 1.5 m/s tip speed, above the 0.8–1.3 m/s studied and near Leiden’s 1.6 m/s maximum. Leiden’s drilled-hole sparger means pCO₂ is likely to rise, it has no Raman port for glucose control, and its virus filter comes from a different supplier.
G-2611-01, High, blocks the engineering run: peak pCO₂ at 200 L stayed between 62 and 95 mmHg and was never studied as a factor, and the FMEA does not assess it. The proposed action — six 3 L scale-down runs at 120–180 mmHg before the engineering run, plus a CO₂ stripping strategy in the Leiden recipe — goes to Sam Patel, due Oct 30.
The Gap writer proposes actions. It never decides or closes a gap.
Ten sections, from purpose and scope through parameters and control strategy, equipment fit and scale-up, analytical methods, risk assessment, holds and stability to open gaps and agreed actions. Every statement cites its source, and the hold decision Lena just made is already in section 9. It exports as PDF, as Word, or as structured parameters for Leiden’s systems.
Every gap that blocks the engineering run needs an agreed action before anyone signs, so the Sign button stays locked. Lena reviews the four the Gap writer proposed — pCO₂, the unassessed second supplier of medium A, off-line glucose without Raman, and the engineering-run sampling plan — each with its owner and due date, and agrees them.
Dr. Maya Chen signed for the sending site on Oct 5. Lena signs TTP-2611 v1.0 with her password and the meaning “Approved — transfer lead”, confirming she reviewed every gap decision that blocks the run. Sam Patel signs for Leiden, Omar Haddad approves for Quality, and TT-2611 moves to Engineering run.
“Protocol signed by all four — TT-2611 moves to Engineering run.”
The same transfer, seen by the sending site, the receiving site, Quality and the transfer lead who holds it together.
Six agents read the records, check the package against the transfer checklist and write every gap; the transfer lead decides each one.
Reads development reports, batch records, FMEAs, methods and equipment lists; records each one’s code, version, effective date, product, site and scale, and splits it by unit operation.
Extracts every process parameter — set point, operating and proven ranges, class and scale-dependence — with its source passage, and normalises units.
Compares sending and receiving equipment for each unit operation and computes the scale factors — power per volume, tip speed, kLa, CO₂ stripping.
Checks the package against the transfer checklist for the modality and marks each item found, partial, missing or in conflict, citing the passages that satisfy it.
Writes each gap with its evidence, severity, what it blocks — engineering run or PPQ — a proposed action and a suggested owner.
Drafts the tech transfer package, the transfer protocol and the engineering-run sampling plan in the company template.
Decides each gap. The agents propose; a named person decides.
Anyone on the transfer can ask about a parameter, a gap or a signature — or tell it what to change. Answers cite the passages they come from.
Which hold time should Leiden use for the neutralised pool?
The executed batch record allows 48 h at 2–8 °C; the new hold-time study supports 72 h with HMW up only 0.1 %. I recommend transferring 48 h as the operating limit and 72 h as the proven limit, and updating the batch record at its next revision.
Can Leiden match the agitation?
Not inside the studied range. Cambridge runs 20 W/m³ at 1.1 m/s and studied 0.8–1.3 m/s. At Leiden, matching 20 W/m³ needs about 1.5 m/s, near the 1.6 m/s maximum; matching tip speed would drop to about 8 W/m³. The agreed action runs 1.5 m/s with daily viability and HMW checks.
What does the FMEA miss for Leiden?
Two things: FM-14 credits in-line Raman for detection (score 2), which Leiden does not have, and FM-22 — pCO₂ at scale — was never assessed. G-2611-09 proposes a joint re-scoring session.
Add a rule: every scale-dependent parameter needs a scale rationale
Done. The rule is on, and the Checklist checker re-ran on the open transfers: 2 new gaps — TT-2614 has 6 scale-dependent parameters without a rationale and TT-2620 has 4. Each gap proposes a scale calculation or a scale-down study reference. The change is on the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
Checklists, gate rules and who signs are settings, not a project — changes apply to the next gap check.
| Setting | Default | Choose from |
|---|---|---|
| Checklist for biologic drug substance | Biologics drug substance v4 | Biologics drug substance v4 · Biologics drug substance v3 |
| Checklist for oral solid dose and API | Oral solid dose and API v3 | Oral solid dose and API v3 · Oral solid dose v2 |
| Protocol signature needs an agreed action on every gap that blocks the engineering run | On | On · Off |
| Closing a gap needs both sites | On | On · Off |
| Every scale-dependent parameter needs a scale rationale | Off | On · Off |
| Flag receiving-site ranges narrower or wider than the filed range | On | On · Off |
| Two sources that disagree always go to a person | Always on | Cannot be turned off |
| Who signs for the sending site | Dr. Maya Chen | Dr. Maya Chen · Dana Okafor |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample transfer data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = industry estimate of 40–60% faster package assembly. Context: ICH Q10 (knowledge management) and the WHO guideline on transfer of technology. People, companies and products named on this page are fictional — characters and sample data in the working solution.
The set of documents a receiving site or CDMO needs to run a process: the process description, critical parameters and ranges, materials, equipment and scale-up, analytical methods, risk assessments and hold times. This solution builds it from your development records and lists every open gap with its agreed action.
The Checklist checker marks each item of your transfer checklist found, partial, missing or in conflict, with the passages that support it. The Equipment fit analyst compares the two sites’ equipment and flags parameters pushed outside their studied range. The Gap writer turns each finding into a gap with evidence and a proposed action.
Both values are shown side by side with their source passages, and a person decides which one transfers. The agents never average or pick a value, and that rule cannot be turned off.
Yes. Agents propose; people decide. Only a person agrees an action, accepts a risk or closes a gap, closing a gap needs both sites, and the protocol cannot be signed until every gap that blocks the engineering run has an agreed action.
Yes. The working solution runs transfers to company plants, to CDMOs and from an acquired company’s data room. Each CDMO sees only its own transfer through the CDMO portal.
It ships with transfer checklists for biologic drug substance, oral solid dose and API, antibody–drug conjugates and analytical methods, each versioned. You choose which version applies in Settings.
A process knowledge library of every parameter with its source, the tech transfer package in your company template, a gap list with owners, the engineering-run sampling plan and the transfer protocol for signature. The package exports to Word or PDF, and parameters export as structured data for the receiving site’s systems.
The Agentic Solution Engine builds and deploys it from your requirements — your transfer procedure, checklists, package template and the development records of a recent transfer — and it goes live once every quality gate has passed.
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