Provided below are:
● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3).
The issue begins with an exploration of how USP is evolving its standard setting approach for the new generation of biologic products and processes, and follows with a complementary review of the challenges in raw material and excipient use in biologics, in particular. The next two stories focus on the regulator and industry learnings, respectively, in gaining experience with the unique considerations that cell and gene therapies present in facility and operation management.