BioPharm International, June 2024

Technological advances are aiding manufacturers to streamline aseptic processes and improve time-to-market.

Using a multi-pronged strategy to find optimum, tailored formulations is best.

The biopharma industry is looking at continuous chromatography for sensitive molecules.

Packaging and packaging line innovations are addressing the industry’s growing use of biologics.

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

Biosimilar analytical assessments focus on demonstrating biosimilarity and interchangeability with the reference biologic.

Improved efficiencies and reduced costs are clear advantages of automating drug manufacturing processes.

Asking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.