BioPharm International, January 2024

Revolutionary therapies restructure pharmaceutical manufacturing.

There are positive indications for future growth.

The authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.

The success of mRNA-based vaccines paves the way for mRNA in oncology and beyond.

Both adherent and suspension cell culture approaches have their pros and cons, which must be considered for process development.

Developing cell-based potency assays for cell therapies requires meticulous coordination.

Product and process understanding are essential to effective resin selection.

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.

GSI shortages result from how hospitals buy GSI drugs, and the underinvestment in manufacturing operations that follow.