Challenges and solutions to manufacturing of low viscosity, ultra-high concentration IgG1 drug products: From late downstream process to final fill finish processing.

Challenges in manufacturing of high concentration antibody formulations have seldom been discussed. These are observed mainly form late downstream operations where antibody gets concentrated to its final strength, to final fill finish processing and containerization of the product. Present paper summarizes challenges typically observed in manufacturing and processing of high concentration antibody products and provides turnkey solutions to these typical challenges in order to have their consistent and robust manufacturing process.