Lateral Flow Test Manufacture

“BBI’s experience and world recognised Quality Systems gave us the confidence to move forward”

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Robust and flexible manufacturing options

Whether your assay is established within the market, is previously untested, or is unpredictable in terms of demand, your priority as a supplier is to ensure that it can be manufactured on time, in the required numbers and to the highest quality, whilst remaining cost effective.

At BBI Solutions (BBI), we offer robust and flexible manufacturing options to cater not only for routine manufacturing production but for spiked demand or supply as part of a disaster recovery program. For technically challenging unstable manufacture or assays with high failure or reject rates, we are able to develop a programme of work to address these issues.

Outsource to the experts in lateral flow

Whether you are a new start-up company looking for someone to manufacture your assay or a fast growing company under pressure to meet increasing demand, our manufacturing service will deliver the results you need to fulfil your customers’ expectations:

- 3-4 month technical transfer to manufacturing – BBI has extensive experience and expertise in successfully transferring IVD products to manufacturing, regardless of the project complexities, including transferring assays into BBI for routine manufacture.

- Competitive product pricing – Using our automation capabilities to manufacture on a large scale will drive production costs down without comprising quality, giving you the opportunity to competitively price your product in the market.

- Reliable supply – We have more than 60 assays in routine manufacture across our facilities located in the UK (Cardiff, Wales; Dundee, Scotland) and the USA (Madison, Wisconsin).

- Quality Assurance Guaranteed – We’re certified to the world recognised Quality System for Medical Device and IVD Manufacturers, ISO 13485 and have experience working on FDA projects, so we can guarantee that the entire process is executed to the highest quality specifications within the industry.

Full regulatory ownership and post market support

At BBI we also offer full regulatory ownership and post market support. Ask us how we can help you with complaint handling, post market surveillance and vigilance and regulatory reporting.

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BBI’s manufacturing capabilities

- 30,000 sq feet for manufacturing
- 5 to 100K+ device batch sizes
- Facilities located in the UK (Cardiff and Dundee) and the USA (Madison)
- ISO13485:2003 and ISO9001:2008 certified QMS systems across all sites

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Key benefits

- Quality assurance guaranteed – We’re certified to the world recognised Quality System for Medical Device and IVD Manufacturers, ISO 13485 and have experience working on FDA projects, so we can guarantee that the entire process is executed to the highest quality specifications within the industry.

- Cost competitive – Using automation to manufacture on a large scale will drive production costs down without compromising quality

- Flexible options – Catering for spiked demand and technically challenging manufacture

- Reliable supply – We have over 60 assays in routine manufacture across 3 global sites

- Results – Supporting problematic assays and smoothing your supply

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