Assay development doesn’t happen overnight. It generally takes between 12 and 24 months to design, develop and manufacture a new assay which is why you need to think carefully about the company you choose to create it. After all, you will be working closely with them for an extended period of time so it helps if you communicate well. With this in mind, there are several factors to consider when looking for an assay development company.
Do they cater for your exact needs?
Your first choice company for assay development should be able to meet your expectations in terms of batch size, developmental stage and quality when it comes to the nanoparticles used. So for example, if you only require a few thousands assay samples to start with this shouldn’t be a problem. Conversely, if you’d like hundreds of thousands of samples for an automated set-up this also shouldn’t be a problem.
With regards to the developmental stage of your product, it shouldn’t matter whether you are in the very early stages and require help with the design process or whether you already have an existing product as part of an established market. Scientific research is a huge part of assay development and the more help your chosen company can give you the better.
In terms of quality, the assays manufactured by a research company should meet GMP standards at the very least. The production facility should be ISO 13485 and ISO 9001 accredited as well so that you know there are quality management systems in place to guarantee your product.
Do you get a dedicated team of researchers/scientists for your assay project?
There aren’t many assay development companies that dedicate a research group to your specific project but if you can find one then this will be a benefit. The more time researchers can spend designing and developing your assay the quicker you can get it into production and the quicker you get the data you require for further research purposes.
Will your development project be phased?
By splitting your development project into distinct phases a development company allows you to retain control of the entire process. They also provide you with the opportunity to check for feasibility and reliability before putting your assay into full scale manufacture. This is an important point to remember if you are starting your assay development from scratch with no feasibility studies already done.
Who will ‘own’ your assay following production?
Most development companies retain the rights to the assays they design and develop even though their customers have paid to have them created. A small number are different though and actually hand over the case file to you so that you own your assay and all of the information pertaining to it. These are the development companies to look for as they guarantee a future free from disputes regarding your assay and what exactly can be done with it.