Lateral flow manufacturing case study

Industry: Infectious disease testing
Sample: Human blood
Target: Detection of antibodies to HIV-1 and HIV-2
Immunoassay format: Sandwich (Non-Competitive)
Label: Gold
Time to result: 15 minutes

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The Brief:

Abingdon Health’s customer previously employed a manufacturer in the Far East. The test had reached design freeze, however the supply chain and communication channels were challenging. Looking for a consistent, collaborative European based solution for their lateral flow manufacturing, the client approached Abingdon Health to manage a simplified supply chain and transfer the test into routine manufacturing. The test is a high sensitivity and high specificity infectious disease test that mandated consistent product quality.

How Abingdon Health met the brief:

Abingdon Health used its established network to source and reselect quality and sustainable materials. Our technical transfer team applied the new materials to the assay’s specification, completed the verification & validation and scaling up.

The process from validation into routine production was done in close collaboration with the client.

From the outset of the project Abingdon Health’s team knew there was no room for error and was committed to meeting a high-performance requirement with approval coming via independent European reference lab evaluation.

The client selected Abingdon Health on our ability and commitment to meeting the deadlines.  Abingdon Health were also willing to commit ongoing product improvement programs and operate as an extension of the client’s team but bringing our lateral flow manufacturing know-how and capabilities.

Outcome:

The client was able to focus their resources confident that their manufacturing needs were being met. The collaboration ensured that the forecasts were planned and the strong communication delivered a supply chain solution that was efficient and met product demand.

“There is a high bar for achieving CE marking for this lateral flow test…which requires a lot of commitment and accuracy…There was a lot of work needed [to apply new materials to the specification] and there was a requirement to find someone [a company] with a broad spectrum of knowledge, experience and reach across supply chains…Without exception the group of people involved were just as committed to the project as I was…”

Senior Technical Lead

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