BioPharm International September October 2025

Each step of development and manufacturing is becoming more interconnected, and BioPharm's September/October issue highlights the strategies, tools, and innovations shaping the future of the field.

This second part of a two-part article provides a clear understanding of microbiological load reduction during cleaning processes in the non-sterile pharmaceutical manufacturing.

Formulation and analytics are combining to advance drug development synergistically, with evolving tools and related strategies shaping quality, scalability, and innovation.

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

Engineered biosynthetic pathways provide new avenues for accessing complex molecules.

Solutions are emerging to manage advanced modalities and evolving regulatory requirements for viral clearance.

With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.