Evaluating an established process for a receiving site
You have development knowledge or a process package and need to assess its compatibility with the proposed receiving environment.
CDMO · Technology Transfer
Radiopharmaceutical Technology Transfer
HUAHE supports the transfer of radiopharmaceutical processes and analytical methods to receiving sites. Within the authority granted by the client or technology owner, we assess gaps between development knowledge and receiving-site capabilities, develop the transfer plan and coordinate training, on-site implementation, engineering or trial runs and analytical method transfer, with documentation supporting acceptance by the receiving site.
Discuss technology transfer
Your starting point
Where this service fits
Transferring analytical methods
You need to plan the documentation and coordinate analytical method transfer activities at the receiving laboratory.
Connecting transfer planning with implementation
You need support with technical preparation, training, and agreed trial work in addition to document transfer.
Scope of work
Process and analytical method transfer
Integrated delivery
HUAHE plans and coordinates delivery by specialist organizations, with responsibilities, stage deliverables and acceptance criteria defined in the Project Master Plan.
Scope and responsibilities
Confirm which processes and analytical methods will be transferred and the authorization to transfer them. Establish the technical baseline from product, formulation, process and analytical knowledge, control requirements, material specifications, development risks, historical deviations and stage-specific acceptance criteria.
Gaps and risks
Assess receiving-site facilities, utilities, equipment, materials, methods and personnel against the technical baseline. Assess material and equipment equivalence, identify required adaptations and document site-specific risks.
Plan and preparation
Agree on the transfer plan, supporting documents, materials, training and schedule. Define the conditions and records needed for implementation and evaluation.
On-site implementation
Support training, engineering or trial runs and analytical method transfer at the receiving site, with contemporaneous process and implementation records.
Evaluation and closeout
Review implementation results against agreed acceptance criteria, document deviations and open issues, and establish the basis for receiving-site acceptance.
Project outcomes
What you receive
You receive a technology transfer package covering the gap assessment, transfer plan, training and implementation records, analytical method transfer, trial-run results and documentation supporting acceptance by the receiving site, with deviations and open items tracked through closure.
- Transfer readiness and receiving-site assessment summaries
- Agreed transfer plans and technical support records
- Training materials and implementation records
- Analytical method transfer documentation, trial-run results and documentation supporting acceptance by the receiving site
- Transfer reports, deviation and open-issue records, and agreed closeout documentation
Technology transfer requires appropriate authorization and the applicable site licenses and quality systems. Transfer scope, site responsibilities and stage-specific acceptance criteria are defined in the project agreement, applicable quality agreement and jointly confirmed transfer plan. Technical decisions, validation, change control, manufacturing, testing and batch-release responsibilities remain with the designated authorized parties.
Discuss a process or analytical method transfer
Tell us what you intend to transfer, its current development stage, and the proposed receiving-site context. A non-confidential summary is enough to begin.
Discuss technology transferConnected expertise
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