Lateral Flow Test Development

Case Study

Verax Biomedical partners with BBI Solutions to develop assay for FDA clearance: One supplier to deliver assay stability, robustness and manufacturing scale up

Verax Biomedical were seeking a custom conjugation expert, to deliver the required stability for the development of a world first rapid test for the detection of bacterial contamination in platelets. Discovering BBI Solutions for a custom conjugation project gave rise to the beginning of a full assay development and a long-term manufacturing partnership.

The BBI team took a very complicated problem and delivered an assay that is very simple to use and easy to interpret - successfully adapting the technology to the application

The Challenge

Verax was founded upon a single vision – to improve patient safety by detecting bacterial contamination in blood components, cells and tissues prior to transfusion and transplantation.

The company set out to ‘fill the hole’ in blood safety by developing a very complex Pan Genera® Detection (PGD®) assay to rapidly detect all the likely types of bacteria that are found in blood components.

A challenging assay requiring FDA clearance, the company needed an experienced conjugate partner to deliver stability, an assay developer providing a robust platform and manufacturing capability to scale up to meet demand.

The gold and conjugation processes at BBI are unrivalled - we found that BBI was the best that we could work with

The Solution

Firstly, the company sought a partner with the level of conjugation experience necessary to deliver the required stability.

Chief Executive Officer (CEO) James Lousararian explained "In a bio-chemical platform, stability and consistency is crucial. When added to the multi-target complexity of our assay, this put an enormous premium on having a partner experienced in making stable and consistent conjugate."

On the selection of BBI Solutions, James commented “The gold and conjugation processes at BBI are unrivaled – we found that BBI was the best that we could work with.”

While BBI was initially selected for its gold and conjugate supply, on learning about their excellent reputation for developing hundreds of assays under regulated conditions and FDA design control, the relationship quickly expanded to full development and a long-term manufacturing partnership. Meeting all Verax’s needed requirements from one supplier.

With 6 million platelet transfusions performed annually worldwide, BBI was also able to offer Verax the ability to scale up when required through its FDA registered manufacturing facility. The facility has a capacity of 15 million assays annually with batch sizes up to 100k.

What started as a component supply and service relationship quickly blossomed into a collaborative development process and a real partnership

The Result

By partnering with BBI, Verax met its objectives, delivering a world first product that has proven to be remarkably effective and consistent in the field.

James commented "What started as a component supply and service relationship quickly blossomed into a collaborative development process and a real partnership. The team took a very complicated problem and delivered an assay that is very simple to use and easy to interpret – successfully adapting the technology to the application."

The demonstrated effectiveness of the product led the US FDA to clear Verax to label the Platelet PGD Test as a safety measure for single donor platelets, instead of merely a process or manufacturing quality control or QC test.

The only FDA cleared safety measure for this application; the Verax Platelet PGD Test is used in hospitals and blood banks throughout the USA, Europe and Middle East.

Verax and BBI have continued their collaboration looking at ways to further develop and improve the assay as part of an ongoing partnership.

Feel free to get in touch, to discuss your next assay development.

Copyright © 2019 BBI Solutions. All rights reserved. Designed trademarks and brands are the property of their respective owners. BBIUS