Whitepapers

This paper details various USP subvisible particulate tests used to assure the minimization of particle counts in intravenous injections and the requirements and technologies used to meet them.

This paper includes a brief introduction to light scattering instruments and techniques, and how they are coupled with fractionation techniques. For several classes of vaccines – including subunit vaccines, mRNA-LNPs, polysaccharide conjugates, and plain old viruses – case studies demonstrate the utility and breadth of analyses using the light scattering toolkit. These include measuring size distributions, characterizing protein-protein binding, and quantifying glycan content in glycoproteins or nucleic acid cargo in nanocarriers. Multiple ways to detect aggregation and other measures of stability are also described.

The proportional–integral–derivative (PID) control mechanism is used for a variety of processes, including dissolved oxygen (DO) control. This protocol introduces a method developed to optimize the PI values on Eppendorf bioprocess controllers.