Biofortuna’s experienced scientific team offers a wide range of services to assist in the development of IVD immunoassays. Taking your assay through feasibility to technical transfer and into full scale manufacture within our ISO: 13485 accredited facilities.
Design and Development
Outsourcing your assay development to Biofortuna can give you the additional resource to reach market more efficiently. We can add the resource to your team in order to design and develop your ELISA based assays, optimise coatings and stabilise antibodies and proteins.
Technical Transfer & Validation
After successful design and development projects and post design freeze a technical transfer project can begin. In this stage the manufacturing process is scaled up and assessed in order to produce a robust reproducible procedure. Procedures are transferred to either Biofortuna’s manufacturing suite or a manufacturing site of the clients choosing. As a ISO:13485 and FDA registered site, 3 validation lots will then be produced under the relevant quality standards. These batches can then be used to generate data for technical validation, clinical validation and for submission to notified bodies.
Biofortuna’s manufacturing suite can provide an established site to launch a global immunoassay product. All processes and protocols within Biofortuna’s manufacturing facility can be performed to ISO:13485 standards and FDA CFR21 part 820.
Services currently offered:
Contact us now to discuss your project’s needs and requirements.