A Design for Manufacture Approach to Diagnostics
Our Scale-up and Technical Transfer team are dedicated to bringing lateral flow products from development through to manufacturing. Our expertise lies in ensuring your product can be transferred under our quality management system into manufacturing at scale in a repeatable, cost-effective and robust manner.
We bring in development projects from customers at this stage or we seamlessly work with our in-house CRO team to transfer products that have undertaken proof of concept and optimisation at Abingdon Health. Importantly our CRO & CDMO teams are all focused from day one on “design for manufacture”, to ensure cost-effectiveness, scalability, and usability, as well as technical performance.
Our Technical Transfer team have a long-established track record of scaling up and transferring into manufacture high quality, robust lateral flow rapid tests across the clinical, animal health, biosecurity, food, plant pathogen and environmental testing markets, amongst others.
Key aspects of scale-up and technical transfer include ensuring that the supply chain is scalable and that all components and reagents can be procured at volume, cost-effectively. In addition, the team focus on transferring lateral flow products onto our high-throughput instrumentation, building Standard Operating Procedures (SOPs), Bills of Materials (BOMs) and controls, so that once transferred to manufacturing, batch production is robust and repeatable.
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 or not our CRO team has completed the R&D proof of concept and optimisation phase work, our Technical Transfer experts help our customers:
- Transfer processes from bench to routine manufacture after Design Freeze
- Implement formal QC methodologies for each project
- Identify, tailor and implement a strong supply chain
- Manufacture the pilot batch
- Deliver 3x Technical Transfer validation batches of each product, from minimum quantity to routine manufacture batch size
- Develop formal SOPs and BOMs
- Complete final output review(s)
Working Hard To Help You Achieve Your Goals
Abingdon Health is proud of being approachable and values its long-term collaborative partnerships. Dedicated account managers and experienced teams of R&D, tech transfer and manufacturing experts work hard to ensure the delivery of optimum rapid test solutions for the life cycle of product portfolios.
We’re passionate about imparting our knowledge and expertise to help you hit your goals. Contact our team to see how can take your assay from R&D to end-users.