Our contract development capabilities
At BBI Solutions, our capabilities allow us to take assay development from initial antibody screening through to routine manufacture and beyond.
We have over 25 years’ experience developing qualitative, semi quantitative and quantitative assays using the latest detection technologies including fluorescence, latex, metallic and paramagnetic nanoparticles.
Whether you require the complete outsourced service or just an initial feasibility analysis, we are able to provide customised development packages designed to accommodate any sample matrix, application, budget and requirement level.
The tests we have contract developed are used in a variety of settings including military field use, farms, laboratory and research institutes, hospitals, physician’s offices, and at home.
We are proud to have supported our customers with over 250 lateral flow development projects. Many of these are in routine manufacture across our facilities located in the UK and the USA.
Our flexible turnkey approach
Depending on the complexity of the assay and your requirements, a typical development programme can run from 12–36 months and will work as follows:
Our turnkey approach means you’re not locked in. A dedicated team of scientists work on your product alone and at the end of the development, we hand over the design history file so that you ‘own’ your own test, a service offering unique to BBI.
Post Market Support
At BBI we also offer post market support beyond assay completion. Customers can benefit from our knowledge in getting assays through the required regulatory stages and into the hands of the consumer. BBI will even take on the full named manufacturer responsibilities and submissions if required.
Next generation assay development to enhance the performance of your test
BBI has an unparalleled technical skill set and access to the latest performance enhancing platforms and technologies to help customers make the best test possible. Ask us about our:
- Sensitivity enhancement technology – offering you the opportunity to potentially increase the sensitivity of your assay – without increasing its complexity of use
- Award winning integrated platforms – simplifying the process for end users whilst reducing the risk of user error and cross contamination
- Novarum DX mobile reader solution – allowing quantitative analysis in real time using smartphone technology. Results sharing and databasing of test data
ELISA to lateral flow
Are you looking to transfer your existing lab based test to a point of care (POC) setting? We have considerable experience in converting ELISA to lateral flow.
The BBI difference
- Choice and flexibility – an end to end modular solution tailored to your individual needs
- Quality – FDA and ANVISA registered manufacturing sites. ISO13485:2003 and ISO9001:2008 certified QMS systems across sites
- Innovation – sensitivity enhancement technology, award winning platforms, mobile reader solutions
- Partnership – the design history folder belongs to you
- Experience and Trust – more than 250 different projects completed under regulated conditions and a design control system at FDA standard where required
- Results – outputs agreed at the start, ensure you get the results you demand