Outsourcing Outlook

This article explains the 4 shifts enabling faster, lower-risk, commercially successful biologics technology transfer.

Lilly is set to acquire Merida Biosciences for up to $2.875B, gaining a precision autoantibody-degrading platform led by phase 1 candidate MER511.

This week’s PharmTech.com content covered AI agent authority, hold-time and nitrosamine risk frameworks, biologics formulation, 3D bioprinting, and major oncology and dealmaking news.

PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.

The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.

Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.

2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.

AI can turn medical device risk management into a continuous signal.