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

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 ...

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

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 ...

Helogen collaborates with University College London to produce bone substitutes in microgravity while opening a new aerospace manufacturing hub in LA.

Merck KGaA invests €13 million to expand Bengaluru manufacturing site, boosting biological buffer and raw material production for the Asia-Pacific region.

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

Figure 1A: Antibody–drug conjugate (ADC) structure and delivery pathways; linker chemistry determines the mechanism by which cytotoxin release occurs. This schematic shows a monoclonal antibody (MAb) ...

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 ...