Evaluation of methods for large scale preparation of antibody ligand conjugates

A rapid, single vessel method for preparation of clinical grade monoclonal antibody-chelating agent conjugates has been evaluated. By use of diafiltration methodology, currently employed dialysis step(s) that are normally used for the production of immunoconjugates may be eliminated. This technique has the advantage of eliminating the use of large amounts of buffer and the several days of time associated with purification of the product conjugate from unreacted ligand by dialysis, reduced risk of metal, pyrogen, and bacterial contamination, all coupled with the ability to produce multi-hundred milligram amounts of product suitable for vialing under GMP conditions for clinical applications. Evaluation of the product by this method indicates a superior quality of purity as compared with immunoconjugates prepared by the established methods.