Shifting the Biomanufacturing Paradigm - Intensifying Upstream Processes

Samsung Biologics' pending PolyPeptide deal adds peptide API manufacturing, including GLP-1 supply, to its antibody and ADC CDMO services.

The deal gives Fresenius options on biosimilars spanning monoclonal and bispecific antibodies, ADCs, and fusion proteins, starting with polatuzumab vedotin and teprotumumab, and could expand its portfolio from 29 to 66 molecules.

FDA set a May 1, 2027 target date for AMT-130, a one-time gene therapy that silences the huntingtin gene, and plans an advisory committee meeting.

Inovio reports that Voceryq spared 27% of adults with recurrent respiratory papillomatosis from surgery for 12 months in a 26-patient efficacy group.

Three case studies show how automated Raman plate reading can triage samples before chromatography in bioprocess development.

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 an interview for BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall shares 18-month stability data for a 440 mg/mL trastuzumab suspension and explains how ultra-high-concentration formulations could shorten administration and support at-home injection.