10.28.22 -- Innovative Solutions For mRNA, Bispecific Antibodies, Viral Vectors, And More

As a growing pipeline of novel product types commands existing capacity, sponsors must embrace strategies that will reimagine and reinforce resilience in today’s biomanufacturing ecosystem. CDMOs play a critical role in this effort, as innovators can utilize the advantages of these collaborations from an early stage until they are more assured of the future of their projects.

Bispecific antibodies (bsAbs) have gained increasing interest over recent years because they can bind two antigens, offering unique modes of action compared to monoclonal antibodies. This article describes the further development of a two-step purification process of a bsAb.

mRNA-based therapeutics offer precise and individualized therapies and avoid manufacturing issues associated with recombinant proteins. Additionally, compared with current therapeutics, mRNA is faster, flexible, and more cost-effective to produce. Learn more about key objectives, considerations, and strategies in mRNA manufacturing.

We need to industrialize and rethink how we transition from translational clinical centers at smaller scale toward commercial production and methodologies. How can we improve efficiency in virus production? How can we change from planar surfaces into 3D culture and suspension to reach the higher scales that clinical trials and commercial products will require?

In this article, we give an overview of the theory of scaling. Next, we present workflows and strategies and discuss which data are needed for successful scaling. Then, we introduce a scaling tool developed by Cytiva and present several case studies using the tool.

How do you know if an intensification approach will give you advantages over your current biomanufacturing process, and how do you choose the right one? Three process intensification experts show how different intensification approaches affect outputs using different scenarios.