Contract Manufacture of Lateral Flow Tests — why an integrated approach is essential
In this blog, Abingdon Health’s COO Mark Jones and CTO Nina Garrett outline the benefits of working with a contract development and manufacturing organisation (CDMO) such as Abingdon Health and why an integrated scientific and operational approach is important to not only development of your lateral flow product but also to ensure continued success in manufacture.
The Value of Outsourced Manufacturing
Firstly, let’s consider why organisations outsource their manufacture? Companies contract out their manufacturing for a variety of reasons, for example:
- the technology not being core to their business
- their business being too small to support the overhead of a manufacturing suite
- good risk management by having a second manufacturing site/capability, or
- the cost of maintaining a compliant quality system being prohibitive.
One clear benefit is that they don't have to invest in and maintain the required operational infrastructure and can focus on other aspects of their business.
There are other benefits however in contracting the manufacturing to a CDMO such as Abingdon Health. We have a pool of deep lateral flow expertise and are experienced and involved in both the contract development and manufacturing processes. This cross-functional pool of expertise is often called upon to support the development and transfer to manufacture as well as troubleshooting and managing change control during manufacture.
Leveraging Cross-Functional Expertise
The synergy between development scientists and manufacturing operations is crucial for successful production. This is where CDMO service providers can add significant value to their customers.
Development teams understand the scientific principles underlying the assay, while manufacturing specialists bring expertise in scaling processes and maintaining consistency.
This collaborative approach provides significant advantages:
- Knowledge continuity — teams that develop tests understand critical parameters that must be maintained during manufacturing. Abingdon Health’s development approach is to “design for the user” but also importantly to “design for manufacture.”
- Efficient technology transfer — smoother transition from development to manufacturing. For example, Abingdon Health’s supply chain team are involved in projects from day one to ensure any reagents and materials used in development are scalable and are suitable for high throughput manufacture.
- Rapid troubleshooting — importantly scientific expertise can be quickly deployed to resolve production challenges.
- Continuous improvement — development insights can be applied to enhance manufacturing processes over time; and operational teams can offer scalability insights to the development teams.
Real-World Troubleshooting Examples
We highlight below some real-life examples of how development expertise provides valuable insight in the manufacturing setting:
Raw Material Changes and Mitigation
On occasion, material suppliers may change their formulation or specification. When this occurs, the development team, alongside regulatory experts, can judge the criticality of the material and determine appropriate actions. In some cases, if the material is deemed 'critical,' aspects of the verification process may need to be repeated.
For example, when a nitrocellulose membrane supplier implemented a manufacturing process change, our development team conducted comprehensive flow rate testing and binding capacity assessments. This allowed us to make minor adjustments to spraying parameters, ensuring consistent test performance without requiring full revalidation.
Signal Development Optimisation
In another instance, a batch of tests showed slightly weaker signal development than expected. Rather than rejecting the entire batch, our scientific team analysed the gold conjugate characteristics and identified a minor shift in particle size distribution. By making a small adjustment to the conjugate formulation, we were able to restore optimal signal development for subsequent batches while maintaining the same level of analytical sensitivity.
Assembly Process Refinement
During scale-up of a particularly sensitive environmental test, the manufacturing team reported inconsistent flow characteristics. Development scientists conducted a systematic investigation revealing that humidity variations in the manufacturing area were affecting the assembly process. By implementing tighter environmental controls and slightly modifying the sample pad treatment, we achieved consistent performance across manufacturing runs.
Quality Systems Integration
Another significant advantage of partnering with an established CDMO is access to robust quality systems designed specifically for lateral flow manufacturing. These systems ensure:
- Consistent application of quality standards across all development and manufacturing activities
- Comprehensive documentation supporting regulatory submissions
- Traceability of materials and processes
- Validation of critical parameters and equipment
- Structured change control processes
- Regular internal audits to maintain compliance
For many companies, building and maintaining such systems independently would require substantial investment and specialised expertise that diverts focus from their core business objectives. By partnering with a CDMO such as Abingdon Health, products leverage an established Quality Management System and set of Standard Operating Procedures throughout development and manufacture which ensures consistency and robustness.
Don’t Underestimate the Role of Good Communication!
While outsourcing manufacturing provides numerous benefits, companies understandably want to maintain appropriate control over their products.
Effective CDMO partnerships balance flexibility with oversight through:
- Regular communication and progress reporting
- Defined escalation pathways for technical issues
- Collaborative approach to process improvements
- Transparency in manufacturing operations
- Clear quality agreements delineating responsibilities
- Joint planning for capacity requirements and product lifecycle
The Key Takeaway
One of the key advantages of working with an integrated CDMO is that the essential link between the scientific and operations team is in place, which ensures products are designed for manufacture and importantly that challenges occurring during routine manufacture are handled by a cross-functional scientific and operational team; to ensure product manufacturing remains robust and product quality is assured.
The successful manufacture of lateral flow tests requires more than just equipment and facilities—it demands an integrated approach where for example scientific expertise informs production processes. By leveraging the specialised knowledge and infrastructure of a dedicated CDMO, companies can bring high-quality lateral flow tests to market efficiently while maintaining focus on their core business objectives.
As lateral flow technology continues to evolve with increased sensitivity requirements, multiplex capabilities, and quantitative applications, the value of this development-manufacturing integration becomes even more significant. Contract manufacturers who can seamlessly blend scientific insight with operational excellence will continue to lead in delivering reliable, high-performance lateral flow products to global markets.
Abingdon Health’s team has over 20 years' experience in the lateral flow market and is a knowledge leader in the development, scale-up, transfer, manufacturing and regulatory approval of lateral flow products across a range of sectors. If you would like to understand more about the development, technical transfer, manufacturing and regulatory process and discuss any specific requirements don’t hesitate to contact Abingdon Health's highly experienced team.
