Technical transfer is defined as the verification process by which a rapid test transfers from research and development (R&D) pilot scale production to high throughput manufacturing. At the end of the process, the product is classed as a manufactured product with all necessary validation and documentation completed.
Products which undergo technical transfer to manufacture may be new products developed by Abingdon Health, or a third party, which have achieved design freeze or could be products already manufactured elsewhere.
Technical transfer has 2 key elements:
- Batch manufacturing –replicating the manufacturing process to ensure a reproducible, robust assay.
- Documentation - to ensure quality standards are adhered to.
Generation of manufacturing batches
This typically involves producing the lateral flow product in 3 batches of increasing size, with the final batch being the maximum size expected to meet the manufacturing forecasts. Most commonly these batches are 50 metres of membrane for batch 1, and either 50 or 100 metres for the second batch, and 100 or 200 meters for the third
The objective here is to reduce risk by ensuring reproducibility and robustness on an increasing scale, while also validating the processes employed in manufacture.
Documentation: meeting quality and regulatory requirements
Detailed documentation during technical transfer is critical for quality and regulatory purposes. A typical manufactured product may have over 80 documents associated with its manufacture.
Checking the documentation is fit for purpose and captures all the necessary components of manufacture is critical for ensuring robust manufacturing processes and procedures are able to cope with the rigours of high throughput lateral flow manufacturing.
An additional key objective of the technical transfer process, from both a quality and regulatory point-of-view, is to ensure all staff involved in the production process, both primary production (materials preparation) and secondary production (assembly and final packaging) are fully trained in the processes involved for each specific product.
Output of Technical Transfer
- Established manufacturing protocols
- Completed quality documentation
- Batches of manufactured product
Devices generated during technical transfer are frequently used for stability and shipping studies and also for field trials. Once the technical transfer process is complete any remaining devices generated can be used as sale stock.
Contact us and see how we can meet your quality, quantity and cost objectives..