Reduced-volume bioburden testing represents a practical and defensible approach for low-volume, high-value cell and gene ...

University students attended Biotech Week Boston Campus to learn about career options in a volatile biopharma industry and ...

Sanofi says integrated continuous purification is a “universal solution” for downstream processing as it prepares for ...

Examine the use of CHT™ XT Media, a ceramic hydroxyapatite mixed-mode resin, to facilitate purification of various large ...

Allogeneic cell therapies offer scalability but require expanded infrastructure to build a viable commercial foundation ...

Dan is currently a trade media relations expert at Sartorius, and he formerly led the news domain of Bioprocess International ...

Drug sponsors seek to capitalize on opportunities created by streamlined regulations for biosimilar characterization.

The successful European Medicines Agency inspection is the latest in a string of positive news for the big Chinese biotech ...

Increasingly, viral-clearance studies depend on integration of complementary analytical approaches for impurity detection and characterization.

Ion-exchange chromatography (IEC) is a common method for oligonucleotide purification (1, 2). Separation by IEC often uses strong–anion-exchange (AEX) resins at moderate to strongly basic pH values. A ...

The 2011 process validation (PV) guidance document from the US Food and Drug Administration (FDA) states that the number of samples used for PV “should be adequate to provide sufficient statistical ...

Graphical Abstract: We developed a mechanistic model to simulate purification of a viral-protein complex by cation-exchange chromatography on the “wrong side” of the molecule’s isoelectric point (in a ...