Maintaining GxP with a 21 CFR Part 11-Compliant Tracking System

CPHI Award winner, Pauline van der Wijst-Janssen, PhD, product development manager and global technical lead at DFE Pharma, explains excipient variability and excipients’ role in continuous manufacturing.

Pauline van der Wijst-Janssen, PhD, of DFE Pharma, won the CPHI Pharma Award for Future Leader. In this interview with PharmTech, she provides advice for scientists looking to advance to leadership roles.

Coverage from AAPS PharmSci 360 and CPHI Milan featured discussion about impurities, devices, and supply resilience. This week also included topics such as AI accountability, oral peptides, and new licensing deals.

No operator touches a CAR-T batch before demonstrating proficiency. Generative AI users should meet the same standard, and a higher one, because an AI error does not stay inside one batch.

argenx will acquire Unnatural Products for up to $1.15B, bringing oral macrocyclic peptides and new formulation challenges to its antibody portfolio.

Onshoring pharmaceutical manufacturing can be made more practical by collaborating with CDMOs that have gray space, supported by strong relationships with used equipment dealers and OEMs.

Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains how her team managed the study’s strict −80 °C handling requirement, quality release, and site readiness, and how the Almac Adapt approach can apply beyond this program.

The PharmTech AI Pulse Check panel discusses why MHRA and FDA oversight of pharma AI continues past go-live, and who validates the regulators' own AI.