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Next-Generation Immunoassays
Published in Richard O’Kennedy, Caroline Murphy, Immunoassays, 2017
Valerie Fitzgerald, Paul Leonard
While these figures clearly demonstrate its success, the initial impact of monoclonal antibody technology was somewhat hindered by unwanted immune responses to murine antibodies in patients. Additional limitations include poor immunogenicity of some targets and general issues with expression of full-length antibodies, glycosylation patterns and the lack of purification tags [11]. An additional consideration when looking at the monetary outlay for these products is their effectiveness. The use of companion diagnostics could clearly be of huge benefit, if employed as standard with the roll out of any new therapeutic, to ascertain initial suitability to treatment and subsequently monitor effectiveness of the drug on each patient. Indeed drugs such as Erbitux, Herceptin, Glivex and Plavix are all seen to be highly dependent on an efficient diagnostic marketplace, and have benefitted greatly from the experience [12].
Bismuth coordination chemistry: a brief retrospective spanning crystallography to clinical potential
Published in Journal of Coordination Chemistry, 2021
Andrew H. Bond, Robin D. Rogers
The requirements of chemical and radionuclidic purity in radiopharmaceutical use combined with the needs for the therapeutic radionuclide to be bound to a biolocalization agent to facilitate safe and efficient in vivo targeting underscore the importance of coordination chemistry in targeted radiotherapy. When developed in combination with a diagnostic radionuclide (i.e. “theranostics”), targeted radiotherapy has emerged as a growth opportunity in nuclear medicine. Overall, radiopharmaceutical revenues are anticipated to reach $10B by 2024 with a compound annual growth rate of ≈ 9-11% [104]. While a large number of radionuclides may theoretically be useful in targeted radiotherapy, the pragmatism required of a commercial drug launch has largely narrowed the contenders to 177Lu (with a 68Ga companion diagnostic), 225Ac, and 213 Bi, with some notable traction for 227Th demonstrated in Phase I clinical trials led by Bayer [105]. An even more narrow focus has emerged for the chelators that bind the (most often trivalent) radionuclides and tether them to the biolocalization agents, with 69 active and 161 total human clinical trials using derivatives of the 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA)-based framework as of the end of 2020 [106]. From a coordination chemistry perspective, promising opportunities may lay in the design of versatile and patentable (intellectual property is critical for commercial drug development) selective chelators, as evidenced by Bayer’s $2.3B acquisition of Algeta’s radiopharmaceutical-chelator-antibody platform for cancer therapy. Quoting a Bayer expert [107]: “The targeting component of the drug product, the antibody, can be replaced with others, making this a very flexible technology… The key element is the chelator.” Beyond the opportunities in chelator design, novel and synthetically efficient alternatives to the chemistry linking a chelator to the biolocalization agent are an area of promise in which select development efforts have even progressed to in vivo studies [108, 109].