Edward Wilkinson, Vice President of SCHOTT MINIFAB USA and Head of Strategy, explains why a fully integrated bioscience and engineering approach is the key to risk mitigation.
Assay translation from a standard benchtop workflow (benchmark assay) to a microfluidic environment is a process with inherent risks and complications. While a benchtop assay can be well understood, translating the science to a manufacturable microfluidic device presents two significant challenges. The first is how to best miniaturize the assay into a microfluidic environment. The second is how to develop a manufacturable diagnostic device with the lowest possible cost-of-goods. Over time, we have refined our contract development and manufacturing programs to integrate these two challenges. The result is a unique, holistic process which brings together our bioscience and engineering teams from the very outset of the program. This approach has proven highly successful in mitigating risks and developing the most effective pathway to success.
In this article, I will briefly outline the broad risks to be addressed and how our integrated approach can provide greater clarity and confidence about the best way forward.
KEY RISK FACTORS
Without a robust, integrated approach, the critical risks and errors which can be encountered through the assay translation program include:
- Time to market delays
- Financial loss due to errors, delays and avoidable problems
- Loss of investment from missed milestones and program delays
- Program failure
CAUSES OF PROGRAM FAILURE
Program failure can be due to a wide number of factors. These include a product that:
- Is not manufacturable (for a range of reasons)
- Does not meet cost-of-goods requirements
- Is not scalable
- Does not meet storage and shelf-life requirements
- Has unresolvable performance issues
The risks associated with assay translation are complex, varied and can be difficult to foresee at the outset of the program. That’s why we have developed and refined an approach that we know works better than any other. Effective and continual integration between our engineering and bioscience teams means that we can more comprehensively plan for a successful outcome and reduce the risks of the unknown.
Why integration is key
Our bioscience teams face a number of key challenges during assay translation. This includes developing a thorough understanding of the benchmark assay, including all the fundamental drivers of assay performance, including assay sensitivity and specificity. This is a critical part of the program because without comprehensive knowledge about the benchmark assay, it is very difficult and inefficient to identify and mitigate risks during translation before they significantly impact the program. This insight drives development decisions about reagent selection, assay tolerances, material compatibility, and managing interfering substances.
Our engineering teams work alongside the bioscience team from the very beginning to ensure that each step of the development process is matched by our ability to manufacture a successful device. For example, will the selected reagents be readily available for manufacture? Will certain materials inhibit chemical reactions in any way? Will the microfluidic product meet shelf life stability and other performance requirements? Ultimately, every product design feature that we implement must have a compatible manufacturing capability at both low and high scale volumes.
“Our engineering teams work alongside the bioscience team from the very beginning to ensure that each step of the development process is matched by our ability to manufacture a successful device.” Edward Wilkinson
The engineering teams also face complex challenges around device bonding, replication, and designing products that can be manufactured at low cost and high volumes. While it can be tempting to jump straight to prototyping cartridges because it feels like you are making faster progress, we have learned that the more successful course is to focus first on the assay. Our development mantra is that the “assay leads the cartridge, and cartridge leads the system”. Following this sequence ensures you retain product performance and avoid critical mistakes.
Our integrated program focus has become a deeply ingrained part of the SCHOTT MINIFAB culture. Our engineering and bioscience teams now work seamlessly within a stage-gated program framework involving:
- Proof of concept
- Concept development prototype
- Small volumes for clinic trials (regulatory approval)
- Small to high volume manufacturing for commercial launch
Each stage is fully resolved before proceeding to the next which provides confidence about the overall status and future success of the project. Our approach leads to excellence in both bioscience and engineering because these two teams understand and support each other each step of the way. It’s this synergy and transparency across functional teams which sets us apart and sets us on the right course for success.
SCHOTT MINIFAB is the world’s Number 1 contract developer and manufacturer of polymer microfluidic devices for point-of-care life science applications. We have a well-established and proven track record of successful commercialization outcomes and high-volume manufacture capabilities.
Contact Edward Wilkinson
Edward Wilkinson is the Vice President of SCHOTT MINIFAB USA and Head of Strategy. He heads the North America office of SCHOTT MINIFAB and is a trusted advisor and facilitator to clients worldwide. He has a Bachelors in Mechanical Engineering and Law from Monash University, and a MBA from Stanford University. Edward has been instrumental in the successful commercialisation of a wide range of point of care diagnostics and life science consumables. His unique blend of technical and commercial experience allows him to understand, avoid and overcome complicated development and manufacturing problems and roadblocks. If you have any questions or enquiries for Edward, please contact him using the form below: