Sterile Filtration: After purification, the mAb solution is passed through a sterile filter, typically with a pore size of 0.2 microns, to remove any remaining bacteria or other microorganisms.

The main technical challenges faced during the scaling of upstream mAb processes include variations in cell densities, cell viabilities, ... “Addressing these scale-up considerations in upstream mAb ...

The Crucial Role that Analytics Play in Product Comparability, Continuous Quality, and Assessment As more biosimilar molecules are approved for use, development and manufacturing processes are ...

Daniel Pirsch is a Senior Scientist in Upstream Process Development at the Catalent facility in Madison, WI, where he maintains a focus on late-phase projects, including those that were developed ...

One way to address the cost issue is to streamline upstream process development and manufacturing. ... The workflow reduces up to 70% of experiments needed.