Every localisation project, CDMO switch and site consolidation lives or dies on technology transfer. Most failures are not scientific. They come from knowledge that stayed in the sending unit's heads, acceptance criteria nobody agreed, and a receiving site that met the documents but not the process. This playbook follows the structure of the WHO guideline on technology transfer (TRS 1044, Annex 4, 2022), translated into what teams actually do.

SENDING UNITprocess knowledge, development report, history of deviations and changes 0 · Due diligence& gap analysis I · Initiationteam, scope, agreement II · Planningprotocol, criteria, risks III · Executiontraining, batches, report RECEIVING UNITpremises, equipment, qualified methods, trained people, validated process
Figure 1. Transfer as a joint project. Both units contribute at every stage.

Stage 0: due diligence and gap analysis

Before anyone signs a transfer agreement, compare what the product needs with what the receiving site has: equipment train and scale, containment and cross-contamination controls, utilities, analytical capability, supplier approval for materials, and regulatory status in the target markets. The output is a gap list with owners and costs. Skipping this step is the most common reason transfers overrun.

Phase I: project initiation

Joint transfer team
Named leads from both units for production, QC, QA, engineering and regulatory.
Scope and responsibilities
A technical and quality agreement that states who delivers what, and who decides.
Knowledge package
Development report, critical process parameters, control strategy, deviation and change history, not just the batch record.

Phase II: planning

The transfer protocol is the heart of the project. It defines what will be transferred, how success is measured and what happens when results fall outside expectations. Acceptance criteria must be agreed before data exist, for the process (critical quality attributes, yields, in-process results) and for each analytical method transferred. A risk assessment should rank the steps most sensitive to scale, equipment differences or raw material sources.

If the acceptance criteria are written after the batches are made, the transfer has not been tested. It has been described.

Phase III: execution

Analytical method transfer first. Comparative testing, co-validation or revalidation, so the receiving lab can trust its own results before process batches start.
Training and shadowing. Operators and analysts from the receiving unit work alongside the sending unit, ideally on real batches.
Engineering and demonstration batches. Confirm parameters at scale and adjust within the knowledge space before validation.
Process validation and transfer report. Results against every acceptance criterion, deviations and their resolution, and a formal statement that the transfer is complete.

Five common failure points

Failure pointPrevention
Tacit knowledge never written downInterview experienced operators; transfer the deviation history
Equipment "equivalent" on paper onlyCompare design principles and operating ranges, not names
Methods transferred after process batchesComplete analytical transfer first
Raw material source changes unnoticedMap every material and supplier; assess differences
Regulatory filing out of syncPlan site-change variations for each market alongside the technical work

Molgenium supports technology transfers for manufacturers, CDMOs and licensors in Europe and the Middle East, from gap analysis to the transfer report. Talk to us about your next transfer.

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