New Recombinant Metabolic Markers for Assay Development
Scripps Laboratories is modernizing metabolic and anemia biomarkers by offering never before seen recombinant forms of human Ferritin, Apoferritin, and Intrinsic Factor. In recent years, the limitations of native-sourced proteins have become evident and these particular biomarkers have been impacted significantly.
Native human Ferritin is derived from liver or spleen tissue, which is processed in bulk volumes to obtain the yields necessary to support the clinical diagnostic industry. This process is arduous and is dependent on donor organs, which are not always available. Procurement of these tissues is unreliable and does not allow for the uninterrupted, long-term supply of purified Ferritin.
Native porcine Intrinsic Factor is a key component in clinical diagnostic assays for vitamin B12 and it has been in short supply in recent years. Although this is a porcine-derived product, difficulties exist in the procurement of its starting material. The extraction process used for decades to obtain porcine viscera underwent a change several years ago, due to environmental and health concerns surrounding the old process. The new process adversely affected the quality and yield of Intrinsic Factor, disrupting the steady supply of native Intrinsic Factor to the clinical diagnostic industry.
The Scripps Laboratories Recombinant Product Development Team recognized the challenges associated with native tissue procurement and got to work developing recombinant forms of Ferritin and Intrinsic Factor. The results are ground-breaking recombinant proteins designed specifically for use in the clinical diagnostic industry.
Recombinant Ferritin & Apoferritin
Scripps Laboratories is developing recombinant human Ferritin and Apoferritin (Ferritin without iron) for use in clinical diagnostic assay development and production. We have created a recombinant form of the 24-subunit molecule, comprised of both the heavy and light chain Ferritin subunits. We are working on recombinant Ferritin, but data generated to date indicate recombinant Apoferritin is homologous to native Ferritin.
On a clinical immunoassay analyzer, the recombinant performs as expected and its reactivity is similar to that of native Ferritin. Upon SDS-PAGE and western blot (WB), the recombinant and native molecules present matching profiles. Both proteins run at the same molecular weight (MW) on SDS-PAGE and their antibody staining patterns are indistinguishable in WB. Of note, the WB profiles were obtained with an antibody specific for heavy chain Ferritin and another for light chain: The staining patterns demonstrate the heavy and light chain profiles of recombinant and native Ferritin are virtually identical.
Given the notable similarities in physical characteristics and assay reactivity, we expect recombinant Apoferritin and Ferritin to be suitable replacements for native liver and spleen Ferritin. They will be excellent solutions for the steady, long-term supply of the bulk quantities required for clinical diagnostic applications.
Contact us for more information or evaluation samples.
Recombinant Intrinsic Factor
Our Recombinant Protein Development Team is working diligently on human Intrinsic Factor for use in clinical diagnostic assays. The recombinant protein is produced in a mammalian cell line, is glycosylated, and displays a molecular weight of 50 kDa, which is equivalent to the MW native human Intrinsic Factor. Though still in development, early purity and B12-binding results are promising and we expect our recombinant human Intrinsic Factor will be a reliable and sustainable alternative to native porcine Intrinsic Factor.
Contact us today to be notified when Recombinant Human Intrinsic Factor is available.