Are you a biotech startup or university spin-off company and you want to transform your biomarker or concept assay into a product that is ready for the CE/IVD market or FDA approval? Have you thought about the steps that are required to get to this point? Do you have the experience and/or the resources to make this conversion?
Great concept assays and newly found biomarkers can come from anywhere, but especially startups come up with new innovative ideas to eventually improve patient health. Although startup-staff have a strong scientific background, feedback and advise from experienced biotech companies can be valuable to create an actual product from a great concept assay.
We support startups to get their concept assay to an IVD product that is ready for the CE-IVD market or even FDA approved. In some cases, a Research Use Only (RUO) product is developed, for commercialization, as intermediate for the CE/FDA approved product.
With more than 20 years of experience and over 50 highly experienced employees, we are dedicated to make your development successful. We can accelerate product launches, because of our vast knowledge on and expertise in the entire process of your product development and manufacturing.
A very short overview of how we do this:
- We start by making an adequate inventory of the needs and wishes of a customer.
- Pre-feasibility experiments and risks assessment will be performed to gain insight in key raw materials, parameters and associated challenges of developing the product.
- The assay is further developed, optimized and risk mitigations are implemented to meet required specifications.
- Once the product design meets the requirements, verification lots are produced. The assay specifications are verified using the verification lots. The product is now ready to sell under RUO label.
- Transfer of the assay is needed from Future Diagnostics’ R&D to the Manufacturing site (either at Future Diagnostics or the customer’s site). Within the technical transfer phase the production of the assay components and their processes including all required documentation will be transferred.
- For IVD label validation batches are necessary. They are produced at the manufacturing site and used to validate that the product meets the specifications. The batches are also used for stability studies.
- After successful validation, your product is ready for IVD registration and commercial launch.
During the entire product development, we initiate and update the technical file, also known as design dossier or design history file (DHF), which is necessary to be able to obtain CE marking or FDA approval. The DHF is a compilation of all documents and experimental records that describes the design history of a finished product. Our delivery manager builds and maintains the file during the complete project process. Finally, the customer owns the complete DHF.