Build versus buy
What does your institution need to own?
An automated system is one part of a programme. Use this comparison scaffold to examine equipment, processes, people and institutional responsibility together.
| Decision area | Automated equipment | Capability transfer | Evidence needed |
|---|---|---|---|
| Facility | Confirm installation footprint, utilities, biosafety and cleanroom requirements with the equipment supplier. | Facility layout planning; Equipment specification; Cleanroom & GMP design. | A site assessment and supplier specifications are needed. |
| Staffing | Confirm the local skills, operator training and service support included in the purchase. | Staff training programmes; Competency assessments. | Obtain staffing assumptions and a training scope for both options. |
| Processes | Confirm which workflows, SOPs, batch records and validation responsibilities are included. | SOP development; Wet lab workflow transfer; Batch record templates; Release testing protocols. | Document process scope and validation responsibilities. |
| Regulatory ownership | Confirm the national regulatory pathway for the proposed device, manufacturing process and clinical use. | Regulatory documentation; Ethics submission support. The local institution owns the regulatory dossier. | Obtain country-specific advice and the local authority’s requirements. |
| Vector supply & IP | Confirm vector access, supply continuity, permitted use and IP rights separately. | Vector / plasmid strategy: supply, qualification and contingency planning. | Review supply agreements and IP terms; no vendor assumptions are verified here. |
| Cost | Obtain a quotation including consumables, service, utilities, staffing and recurring supply. | Cost assessment: evaluate input costs, resource needs and investment requirements. | Comparable, dated total-cost estimates have not been supplied. |
| Operational sustainability | Confirm maintenance, upgrades, support continuity and dependence on external supplies. | Quality assurance framework; External quality assessment; Long-term follow-up planning. | Assess continuity, governance and local capability against the programme’s needs. |
Before a procurement decision
Questions for the local team.
- Which platform and intended use are we preparing for?
- What infrastructure and skills do we already have?
- Who owns the regulatory dossier, quality system and clinical governance?
- What vector and consumables access will the programme require?
- Which workflows and training must stay within our institution?
- How will operating costs, continuity and long-term follow-up be supported?
Compare the same operating boundary.
A procurement comparison becomes useful when both options cover the same intended use, workload and institutional starting point. Record inclusions and exclusions rather than infer an advantage from a headline purchase or programme price.
WIPO distinguishes IP licences, know-how arrangements, material transfers and research collaborations. Agreements need to reflect the particular technology, permitted uses and responsibilities rather than rely on a universal contract.
WIPO: Technology Transfer AgreementsFDA’s CAR-T development guidance covers manufacturing controls, nonclinical development, clinical study design and analytical comparability. It distinguishes product-specific considerations for autologous and allogeneic approaches.
FDA: Considerations for the Development of CAR T Cell ProductsExternal references explain the wider context. They do not verify or endorse the supplied VectorGene or partner offering.
Questions for the programme brief
Initial scope
Compare equipment, facilities, qualification, training and documentation using dated supplier records.
Continuing operation
Request comparable assumptions for staffing, consumables, maintenance, supply access and change support.
Evidence and ownership
Identify who must deliver each requirement and which quotation, specification or contract supports the comparison.
What to prepare for review
- Consistent scope and workload assumptions
- Dated supplier and transfer quotations
- Inclusions, exclusions and unresolved evidence
Working environments
Consider the entire working environment.
Illustrative stock photography provides context for the people, processes and working environments behind this capability.
Separate the layers of this illustrative window. A useful comparison also separates what is supplied from what the institution must prepare.
- Initial scope
- Compare equipment, facilities, qualification, training and documentation using dated supplier records.
- Continuing operation
- Request comparable assumptions for staffing, consumables, maintenance, supply access and change support.
- Evidence and ownership
- Identify who must deliver each requirement and which quotation, specification or contract supports the comparison.
Move across the drawing to explore.
