Manufacturing

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.

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

Sanofi will transfer 20 mature medicines and three manufacturing sites to Cheplapharm for a 26.4% equity stake, closing by Q3 2027.

This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.

The IMA Pharmaceutical and MedTech divisions will be highlighting the TILE-X fill-finish line, a new VPHP BioIndicator, X-PEN autoinjector platform, and a range of machines from its IMA Active, IMA Life, IMA Safe, and IMA BFB divisions at the CPHI Milan event.

In commercial tablet or capsule operations, validation helps protect the site’s ability to produce, release, and supply product without repeated disruption. This article discusses validation as a technical control system that supports manufacturing continuity.

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

Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, provides a preview of the new Sustainability Summit at CPHI Milan 2026.

In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss navigating CMC requirements for new modalities and AI’s involvement in CMC.

Christy Owings, Thermo Fisher, discusses how customs delays and import complexity risk clinical trial supply chains in Latin America.

This week saw predictive modeling, microstructure intelligence, a CAR T-cell safety pause, and major licensing deals reshape pharma manufacturing.

In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discussed how CMC review practices are evolving and what that means for manufacturing strategy.

The finalists for the 2026 CPHI Pharma Awards span 15 categories including API development, digital transformation, manufacturing, supply chain, sustainability, and leadership, with winners revealed October 6 at CPHI Milan.

In August 2026, Heidi Overton was nominated for FDA commission, and a wave of oncology and neuro drugs were approved.

Nitrosamine control is about understanding why nitrosamines form, where they may form, and how to prevent their formation.

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.

In part 2 of his overview on hold times in biopharmaceuticals, Robert Dream details the regulations that govern hold times and how to mitigate risks that can occur during hold times.

European biotechs are advancing bioinks and high-resolution bioprinting for medical devices and regenerative tissues.

McKesson will acquire Precision Medicine Group for $2.25B, integrating clinical research and commercialization services within its oncology segment.

The FDA grants accelerated approval to Ultragenyx's Genglycos, the first gene therapy for GSDIa, raising manufacturing and post-market monitoring questions.

Postmarketing governance must be evidenced across the full life cycle—design, validation, and live monitoring—not documented once and assumed to hold.

Samantha Hadfield, PPD, explains how mixed FSP/FSO models help sponsors balance speed, cost, and complexity in clinical trial outsourcing.