PharmTech Weekly News Roundup – Week of December 1, 2025

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week.

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

How is live-cell, high-content imaging driving drug discovery?

Live-cell imaging, often combined with artificial intelligence and machine learning (AI/ML), provides dynamic insights for phenotypic screening, which accelerates the discovery and optimization of new chemical entities. This methodology is expected to lead to improved target selection and a higher hit-to-clinical success ratio, thereby reducing late-stage drug attrition rates.

What do Immortal Dragons have to do with aging and related diseases?

Etheros Pharmaceuticals is developing a new class of drugs using water-soluble fullerene derivatives that act as catalytic antioxidants to neutralize oxidative stress, a key indicator of cellular damage related to aging and neurodegeneration. The company’s immediate milestones include scaling up manufacturing consistent with good manufacturing practice (GMP) standards and developing reliable biomarkers for use in human clinical trials.

Why do pharma AI agents need smaller, domain-specific models?

While agentic AI systems promise autonomous workflow coordination, they must be trained on proprietary documentation like standard operating procedures and validated procedures, which foundational large language models lack. Domain-specific models, trained intensively on internal data, are crucial for precise decision-making in high-stakes areas such as batch record analysis and quality investigations.

How does the industry close the gap in modern process control and automation for QC/QA?

Digital transformation and advanced analytics are revolutionizing quality control (QC) and quality assurance (QA) by accelerating analysis and supporting the industry’s shift toward real-time release and continuous manufacturing. Investment priority must shift to commercial manufacturing facilities to upgrade instrumentation and automation, as integration of systems and fast data transmission are essential for reliability.

What about batch certification for new manufacturing technologies?

Advanced technologies like continuous manufacturing and artificial intelligence require that qualified persons evolve from traditional document reviewers into digitally fluent leaders capable of bridging science, technology, and regulation. Certification is shifting to a proactive “certification by design” approach, where quality is embedded into process design using real-time monitoring and data-driven controls, moving away from retrospective end-product testing.

What’s there to know about 3D printing in pharma manufacturing?

Additive manufacturing facilitates patient-centric treatment by enabling the precise construction of personalized dosage forms, including modifying dose strength or combining multiple medications into one unit, which is critical for pediatric and geriatric patients. However, primary challenges include regulatory complexity, manufacturing scalability (as layer-by-layer production is currently slow and costly), and the need for new distribution models for highly individualized production.

What are the current trends and innovations in pharmaceutical outsourcing?

Contract development and manufacturing organizations are evolving to offer end-to-end services, establishing strategic partnerships with sponsors that prioritize quality and speed to market. Recent collaborations demonstrate the growing use of AI-enabled research for target identification, alongside expansions in specialized areas such as aseptic filling technologies and radiopharmaceuticals.

How does a “plan, prevent, prove” approach help avoid facility and equipment problems?

Proactive maintenance, often supported by digital monitoring and AI tools, enhances GMP compliance, minimizes downtime, and strengthens regulatory credibility. A strong approach relies on robust facility design that incorporates risk mitigation from the start, such as proper zoning and reliable utility systems, documented clearly in a computerized maintenance management system.