Custom Formulation of IVD Reagents

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Custom Formulation of IVD Reagents

The Expert in Consistent Custom
Formulation of IVD Reagents

When it comes to immunoassays, IVD companies are faced with two major challenges:

i. Developing a quality assay and taking it to the market (Product development and regulatory activities) and,
ii. Maintaining the quality of that assay throughout its life period.

Selection of superior quality reagents (monoclonal/polyclonal antibody with desired performance characteristics) is an important step in immunoassay development. SDIX’s reagent development services are geared towards providing the best support for our clients in this process.

 


Development Target

Read more about SDIX's breakthrough technologies.


SDIX also ensures the ongoing supply of reagents. SDIX has years of experience in large scale production. We provide the facilities and services for monoclonal, polyclonal and calibrators production. Below is a case study which explains our work related to polyclonal production consistency.


Production IVD

Through understanding our client’s specific reagent requirements, we blend reagents exactly as it is needed for individual platforms. We consider various factors such as Low End Sensitivity, Linearity/Slope, Dynamic Range, and Prozone for custom formulation.

IVD Custom Formulation Animation

SDIX provides development focused services in the areas of:

IVD Reagents

Large Scale Antibody Production

Co-Development of Analyte Specific Reagents

Vendor Management