Manufacturing

The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.

Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.

Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.

Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.

Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.

Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.

Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.

Richard Jaenisch weighs how FDA's new NAM rule could reshape preclinical testing and what CMC teams should do now, on Manufacturing Intelligence.

In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss the implementation of risk-based approaches for CMC.

Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.

Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.

Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.

The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.

The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.

The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.

The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.

This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.

Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.

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.

On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.

Christy Owings, Thermo Fisher, on why early supply chain partnership and site visits prevent costly eCOA and clinical trial delays.