In-Line Radiolabeling: A Novel Continuous-Flow System for Commercial-Scale Protein Labeling

Journal of Nuclear Medicine

P. August Schubiger¹  Robert Waibel¹  Olga Gasser¹  Raimo Pellikka¹  Steven W. King¹  Missag H. Parseghian¹  Peter Blaeuenstein¹  Debra A. Harris¹ 

关键词: radiolabeling;    protein labeling;    nuclear medicine;    radiotherapeutic antibodies;    glioblastoma multiforme;   

DOI  :  10.2967/jnumed.108.056812

学科分类：医学（综合）

来源: Society of Nuclear Medicine

【 摘 要 】

A key limitation in developing radiotherapeutic proteins is the expense of manufacturing the drug in small batches using traditional reaction vessels. Removing limitations on the quantity of protein labeled at any one time significantly decreases the cost of production, and nowhere is the need for cost-effective radiotherapeutics more acute than in the treatment of cancer. Methods: We describe a novel method that can rapidly radiolabel, theoretically, unlimited amounts of protein, without causing significant damage to binding potency or structural integrity. Our process controls the reaction rate for the isotope and reactants as they simultaneously flow through a reaction tube. Results: We have demonstrated proof of principle by labeling nearly a gram of antibody with 481 GBq (13 Ci) of 131I during a single 30-min reaction run. Conclusion: Simple to construct, our system is already used to manufacture a radiolabeled antibody, both in the United States and in India, as part of clinical trials to treat glioblastoma multiforme. Modified, this system may be also applicable for nonradioactive labeling.

【 授权许可】

Unknown