Reliability and the consistent delivery of quality lateral flow tests
By working with established material suppliers and combining experience with the latest lateral flow manufacturing automation, Abingdon Health assures the security of supply for all tests and markets, no matter how complex.
With a capacity to produce millions of rapid tests across multiple manufacturing sites, we offer flexible solutions for card and test strip manufacture through to producing assembled devices and kits.
Abingdon Health is certified to ISO 9001 and ISO 13485, and is compliant to FDA 21 CFR 820 and GMP. Abingdon Health also meets regulatory requirements of UK MDR 2002, the IVDD 98/79/EC and the IVDR 2017/746. In addition, our facilities have an establishment registration with the FDA.
Whether you’re looking to expand into new territories with a new or second manufacturer or have outgrown your current LFT manufacturing solution, we offer flexible solutions to meet your needs.
Flexible and Adaptable Manufacturing Solutions
Whether working with newly developed lateral flow assays or tests already on the market, Abingdon Health helps its customers:
- Part or full manufacturing solutions
- Transfer new and existing manufacturing Standard Operating Procedures into routine manufacture
- Troubleshoot test performance and optimise test recipes and specifications
- Conduct scale up from bench to automated manufacture
- Navigate complex regulatory, legal, and commercial barriers to launching products to market
Long-Term Support
- Card and test strip manufacture through to assembled devices and kitting
- Low, medium and high-volume automated manufacture across multiple sites
- Scalable solutions in line with growth plans
- Adaptability in response to spikes in demand
- Stable pricing for budget planning
- International shipping and supply chain management
- In-house regulatory and commercialisation support
Agility
Flexible and scalable solutions to meet growth forecasts while offering contingencies to cope with spikes in demand.
Fulfilment
Batches produced on-time and in-full via established procurement, project management and manufacturing processes.
Reach
Regulatory, commercial and logistics solutions to reach your key markets wherever they are in the world.
An extension of your team
Abingdon Health is proud of being approachable and values its long-term customer-partnerships.
Our team of lateral flow specialists are honoured to share their experience and expertise in pursuit of achieving the best for our customers’ product portfolios.
We also advise on next generation developments, continuous improvement plans and go-to market strategies and offer commercial and regulatory support.
Request a manufacturing project consultation
Our flexible and scalable solutions adapt to meet the different needs of our clients. Whether you’re looking to switch manufacturer, source a second manufacturer, or scale-up production out of R&D, contact our team for a no obligation consultation.
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Abingdon Health’s headquarters and primary LFT manufacturing facility is situated on the York Biotech Campus in York, UK. With a second manufacturing facility located in Doncaster, UK.
Our facilities are certified to ISO 9001 and ISO 13485 and works under IVDD 98/79/EC and in accordance with IVDR 2017/746 and GMP 21CFR820. In addition, our facilities have medical device establishment registration with the FDA and MHRA.
Both sites offer automated manufacturing and connected to international logistic hubs.
