PDA Technical Report 83

Boehringer, AbbVie, ASKA, and Evommune license ADC, IBD, thyroid eye disease, and degrader assets, raising tech transfer demands for manufacturers.

Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains the benefits and challenges of the company’s just-in-time manufacturing solution.

Vivek Gupta of Duquesne University explains at AAPS PharmSci 360 why device decisions can't wait and why excipient makers must test beyond drug molecules.

Industry subject matter experts spoke about the challenges of turning complex molecules into medicines patients can reliably use.

The pharmaceutical supply chain is a complex system with high stakes. USP provides insights on how it is helping industry navigate global disruptions and procurement issues.

Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.

Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.

USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.