Sustainable Recombinants for Assay Development Now and Into the Future
Scripps Laboratories is changing the way the clinical diagnostic industry perceives recombinant proteins. Recombinants have been available for pharmaceutical, diagnostic, and research use for decades. Despite this, their use in clinical diagnostic applications has been limited, as many recombinant proteins have failed to meet the performance standards set by their native counterparts.
We launched our line of recombinant pituitary hormones in 2021 and feedback at the time indicated our customers’ experience with recombinant proteins from other manufacturers was less than favorable. “Recombinants don’t react like native proteins” and “We’ve tried them, but they didn’t work for us” were common responses to the introduction of our new recombinant line. We knew at the time, however, that those opinions would change. Although they had tried recombinants before, they hadn’t tried ours.
One short year and several trial evaluations later, recombinants from Scripps are replacing native proteins across the industry. Our recombinants are being validated for use in the assay panels of the largest clinical diagnostic corporations in the world.
A key reason for this success is the approach taken by the scientific staff at Scripps Laboratories when developing recombinant proteins. Diagnostic assays are complex, sophisticated systems that require precise interaction among the many components. Developing and producing recombinant proteins to work in these systems is intricate, challenging, and demanding. Rather than churning out proteins in assembly-line fashion, each project at Scripps is researched and planned with the primary objective of creating a product that demonstrates reliable and reproducible performance in clinical diagnostic assay systems.
One of the enduring benefits of recombinant proteins, as applied to diagnostic applications, is the sustainable nature of their starting material. Recombinants are sourced from cell lines that are grown and harvested on-demand, which makes the purified protein available to you when needed. This is not always possible with native proteins. Native tissue procurement is unpredictable and the availability of glands and organs has decreased dramatically in recent years. This phenomenon predates Covid-19, but the pandemic exacerbated the scarcity and high cost of these materials. Renewable, responsibly sourced, recombinant proteins are your assurance of a steady, long-term supply.
Producing top-performing recombinants requires a diligence that goes beyond project planning and production. Once a Scripps recombinant is purified, it is tested, and tested thoroughly, before it is approved for release. Each protein is evaluated in a variety of antibody-based detection systems, including clinical analyzers. In addition, no recombinant is released until it meets our high standards for purity, stability, and performance.
Recombinant proteins from Scripps are exceeding expectations and challenging what clinical diagnostic manufacturers can expect from recombinants. Developed, produced, and tested for efficacy in diagnostic applications, our recombinants are replacing native biomarkers in reproductive endocrinology, anemia and metabolism, cardiology, and several other areas of disease diagnosis.
We are eager for you to evaluate our recombinants, so get in touch with us today to bring these ground-breaking products into your lab for evaluation in your assay systems. Contact us.