Developed & Manufactured by Biomedica

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We Guarantee the Performance of our Products

We at Biomedica understand the importance of high quality, well validated research products.

For this reason,

  • We optimize all Biomedica products for reliability, sensitivity, precision, and ease-of-use.
  • We validate our kits extensively according to FDA, EMA and ICH guidelines (1).
  • Our development, production and customer service teams consist of doctorate-level and industry-trained scientists with long-standing research experience.
  • Biomedica’s manufacturing process conforms to the ISO 9001:2015 certified quality management system.

To ensure continued customers’ satisfaction, we strive to meet the highest quality standards and continuously work on improving both our products and manufacturing process.

Examples of our ELISA (Enzyme Linked Immunosorbant Assay) validation process can be found as an example for the following products:

Bioactive Sclerostin ELISA  – Assay Validation:

The assay validation includes spike recovery, linearity, precision, sensitivity and stability studies, that also includes stability testing of the analyte and stability studies on the kit reagents.

In addition, validation has been carried out for all sample matrices that can be measured in the assay e.g. serum, EDTA-plasma, and citrate-plasma.

Examples of expected sample values in an apparently healthy cohort, as well as sample values in clinical cohorts (e.g. kidney transplant recipients) are shown.

A characterization of the antibodies used in the ELISA has also been performed including Biolayer interferometry measurements (Octet) and HPLC analysis.

For more information on the validation of the Bioactive Sclerostin ELISA please click here .

 

Literature

  1. Q2 (R1) Validation of Analytical Procedures , European Medicines Agency, 1995.