FDA Launches Major CGMP Review

This year’s AAPS PharmSci 360 highlighted AI transparency, computer modeling in formulation, oral peptide delivery, and new business models.

FDA approves Sun Pharma’s Ilumya for active psoriatic arthritis, BioMarin licenses a subcutaneous Fabry enzyme replacement therapy from GC Biopharma and Hanmi, and Lonza expands bioconjugation capacity in Visp to meet rising ADC demand.

In the second part of an interview for BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall shares 18-month stability data for a 414 mg/mL trastuzumab suspension and explains how ultra-high-concentration formulations could shorten administration and support at-home injection.

Industry experts discuss how reshoring, fill/finish capacity, and cold chain technology are shaping a more resilient biopharma supply chain.

Lonza's Visp expansion adds 3 multiproduct suites at up to 1200 L plus 500-L single-use capacity to scale commercial ADC production from 2028.

The first-in-class molecule, licensed to Dianthus as DNTH212 outside Greater China, is designed to block type 1 interferon production and BAFF/APRIL-driven B-cell activity with a single drug.

HM15421/GC1134A could become the first subcutaneous enzyme replacement therapy for Fabry disease, with BioMarin paying $70 million upfront.

The IL-23p19 inhibitor tildrakizumab becomes the third drug in its class approved for psoriatic arthritis, and the only one given exclusively by a healthcare provider.