Are you developing a diagnostic microfluidic product? Validating assay maturity is critical for commercial success.
Assay maturity describes a benchtop assay’s readiness to be translated to microfluidic cartridge format. It is important for assay developers and microfluidic product developers to properly assess this level of maturity prior to launching a product development program. Although almost every new diagnostic product begins with an assay which functions reliably on a benchtop, this alone is not enough to optimally reduce program risks. Setting a new product up for commercial success requires a thorough investigation and understanding of gaps in data along with identification and mitigation of any critical assumptions. That is why SCHOTT MINIFAB’s unique approach to assay translation always starts with a thorough assessment and characterisation of the standard benchtop workflow (benchmark assay). It is this deep insight that drives and supports the subsequent stages of the program and underpins the product’s success.
WHAT IS ASSAY MATURITY?
Assay maturity exists on a spectrum and can only be measured objectively with a proven framework and specialist microfluidic bioscience expertise. Benchmark assays are usually well understood by clients and this forms a strong base of knowledge upon which to build. There are, however, many additional factors specific to the microfluidic environment which don’t tend to play a role on the benchtop and thus require a specialist partner to assess. Although there is sometimes understandable commercial pressure on clients to accelerate product development it is vital not to “jump straight in” until this assay assessment has been properly made. Conducting this process before commencing product development ultimately saves time, reduces costs and lowers overall risk.
ASSAY MATURITY ASSESSMENT
Before we commence an assay translation program, our bioscience team conducts a thorough review of your existing concept to establish assay maturity and feasibility for conversion to the microfluidic environment. This process involves a series of immersive workshops with you to understand your technology and share data and information. Assay maturity is determined by a comprehensive assessment and gap analysis that includes a number of important factors such as:
- Is the complete assay procedure well defined?
- To what level has the assay been verified or validated?
- Are all the required reagents defined and validated?
- Are any environmental (such as temperature and humidity), storage or transport factors known to affect assay sensitivity or specificity?
- How critical are pressures, temperatures and surface areas to the function of the assay?
- Are there any known material incompatibilities with assay reagents or workflow?
The level at which these, and many other, questions have been answered helps us define assay maturity.
BENCHMARK ASSAY CHARACTERISATION
Assay characterisation is a key part of our translation process because it establishes a highly detailed and thorough understanding of exactly how the benchtop assay functions. Most importantly it establishes the factors critical to maintaining this functionality in a microfluidic environment. During this stage, we work closely and collaboratively with your team to break down and understand the workflow at its most granular levels. This level of understanding underpins the success of later stages of the program because more risks can be addressed at the outset and any future problems that may occur can be efficiently traced back to the source. Fully categorising the benchmark assay will uncover important gaps in data and risks which can be mitigated at the earlier stages of the program. This leads to greater efficiency and provides the best chance of program success.
PRODUCT DEVELOPMENT PROGRAM
Once the benchtop assay has been fully characterised and feasibility analysis successfully completed, the assay can be considered mature and ready for translation a microfluidic device. Our product development approach is always centred around the assay. Assay leads the cartridge, cartridge leads the instrument. This is why assay maturity is really the key driver of success – it underpins and informs the entire program.
Our team will work closely with you to make sure that your assay is ready for translation before we embark on the development stage of the program. We encourage you to talk to us at any point for advice and support on preparing your assay for successful translation.
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 commercialisation outcomes and high-volume manufacture capabilities.
CONTACT SCHOTT MINIFAB
Our team is ready to help you take your benchtop assay through the translation and commercialisation process. One of the first things we do is work with you to understand the exact stage of assay maturity. This insight avoids critical oversights and assumptions and sets your product development program up for commercial success. This unique approach underpins our proven record of successful program outcomes. The earlier you start a dialogue with us about your assay the better we can assist in guiding you on the most efficient product development pathway.
PhD VP Business Development
VP SCHOTT MINIFAB USA & Head of Strategy
General Manager, Europe
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