As the development of biotherapeutics proceeds through discovery toward the clinic, there is an obligatory increase in the level of performance and validation of assays to monitor the status and efficacy of the candidate molecule. These assays require consistent reagents to perform optimally. As the biotherapeutic progresses into and through clinical trials, there is also a requisite increase in the volume of assays necessary. The problem, simply stated, is that the required high performance of assays cannot be maintained in light of the necessary increase in the volume of assays without a concomitant increase in the supply of high quality, consistently labeled reagents that comprise the assay. The biopharmaceutical industry has not adequately tackled this problem.
Biopharmaceutical companies are seeking a solution to obtaining large scale, single lot batches of the labeled critical reagents that comprise the assays which are necessary to support approval of the candidate therapeutic.
Radix has leveraged our scientists’ many years of experience in large scale protein conjugation and purification to develop a labeling process for antibodies and other assay reagents that is scalable from microgram amounts to multiple gram amounts of input reagents. Additionally, we utilize multiple chromatography methods to purify the labeled product from every labeling reaction to remove aggregates and metabolites that contribute to assay variability.
This scalable labeling process and chromatographic purification of the labeled product allow us to rapidly deliver consistent single lot productions of labeled antibodies and reagents from milligram amounts for discovery efforts to multi-gram scale amounts to produce consistent clinical trial results.
To submit your reagent labeling specifications, please use our submission form.