Therapeutic strategies involving human monoclonal antibodies (mAbs) are becoming increasingly prevalent. However, solutions of mAbs possess unusually high viscosity, caused by their self-assembly into clusters. This is a bottleneck for industry's ability to scale-up manufacturing and imposes product formats that require healthcare professionals to administer the mAb, both of which increase cost. At present, the cost of mAb therapies can reach several thousands of dollars per year, which is prohibitive to their use – irrespective of how well they treat disease. There is thus an immediate and urgent need to address the manufacturing challenges posed by high viscosity, and this presentation showcases bioconjugate approaches to do so. First, a bioconjugate ‘scavenger’ will be presented to achieve the affinity purification of mAbs from cell culture supernatant. Remarkably, the properties of the polymer component within the bioconjugate were determinant on controlling protein–protein interactions between the scavenger and the mAb. Secondly, a bioconjugate strategy will be presented to reduce the viscosity of concentrated mAb solutions. A polymer additive that transiently couples to mAbs will be described that very efficiently prevents mAb self-assembly, leading to reduced viscosity.

Bio-conjugate approaches to mAb manufacturing

2019 Spring National Meeting

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