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.

Efficient virus recovery and impurity removal are challenges for purification of viruses such as H1N1. In a single purification step, Nuvia HP-Q AEX Resin resulted in excellent recovery and impurity removal.

Traditional sequential chromatography usually requires user manipulation which may hinder reproducibility in protein purification runs. Multidimensional chromatography improves the process without sacrificing efficacy. This study compares both purification workflows demonstrating equivalent purity.

Roche Pharma Research and Early Development lab automation specialist, Pawel Linke, discusses their approach to doubling the number of projects in process development without significantly increasing headcount.

The traditional packaging for frozen BDS applications has significant weaknesses at lower temperatures.  This paper discusses new materials and freeze-thaw systems to meet these challenges.