Synexa Life Sciences’ industry leading position in immunology provides the strong foundation for our large molecule bioanalytical services.
We have extensive experience and expertise in the de novo development, validation and production of pharmacokinetic and immunogenicity assays for Biosimilars, Biobetters and New Biological Entities (NBE’s).
We combine solid scientific and regulatory knowledge with the latest technology platforms. These include immunoassay platforms, such as ECL, ELISA, AlphaLisa and kinetic enzymatic assays. We have dedicated cell labs for neutralizing antibody assays, which includes technology platforms, such as flow cytometry and plate-based fluorescence and luminescence readouts.
Thorough assay development, optimisation and validation is best done well in advance of planned studies as the process can deliver significant improvements in assay sensitivity and overall robustness, with implications for sample volume and sample preparation methods. We strongly recommend starting the development and validation process at least six months before the first patient visit.