Technology Transfer refers to the process of transferring all, or part of a manufacturing process from one location to another, or from a technology developer of to a commercial partner. A key goal is that the performance and outputs must remain unchanged, particularly when transferring registered products between sites and locations.
Often technology transfer is a result of scaling-up or rolling out to multiple locations following mergers and acquisitions, as a part of the product’s clinical development and product commercialisation activities, or as activities are relocated within the same site.
How technology transfer takes place
For technology transfer to take place, several legal and commercial processes and documents need to be addressed, including:
- Provision of confidentiality and commercial agreements
- Material transfer agreement
- Deed of assignment
- License agreement
Succeeding in technology transfer
The success of technology transfer depends on the provision of information and data by the “sending location” to the “receiving location”. The information required is recoded and submitted in module 3 of a CTD, but at a greater level of detail and volume, including:
- Equipment specification (DQ, IQ, OQ, PQ) and operating ranges
- Manufacturing process steps/ stages / specifications (manufacturing Instructions)
- Validation Master Plans (VMP) and Validation Reports
- Raw materials suppliers, specifications, and storage / use conditions
- Analytical test methods, equipment used, and specifications
- Training materials
Meeting with the regulatory agencies is advised to discuss any specific requirements and to identify the relevant regulatory framework to be used for the registration of the technology transfer. This may include simple license variations and supplements, through to comparability and equivalence protocols.
Acceptance criteria for individual parts of the technology transfer, as well as the overall success measures, should be agreed in advance.
Need further information?
Woodley BioReg has managed many technology transfers involving both pharmaceutical and biopharmaceutical products. WBR has also successfully presented several comparability and equivalence protocols to obtain regulatory approvals without the need for bridging clinical studies.
While each technology transfer has its own unique requirements, WBR has developed and published a robust set of criteria that can be used as a framework and template for transfer.