In the opening remarks, Michael Kopcha, Director of the Office of Pharmaceutical Quality (OPQ), offered CDER’s perspective on advanced manufacturing and pharmaceutical quality. He began the ...

How integrated pharmaceutical manufacturing helps CDMOs simplify scale-up, reduce complexity, and move from raw materials to finished dosage forms faster.

While braille is mandatory on all pharmaceutical packaging in Europe, U.S. regulatory agencies remain quiet on the issue, according to Pharmaceutical Processing. The U.S. Food and Drug Administration ...

Asahi Kasei acquires Aicuris for €780M ($920M), adding anti-infective assets to its transplant and nephrology specialty pharmaceutical platform.

Join our daily and weekly newsletters for the latest updates and exclusive content on industry-leading AI coverage. Learn More Digital twins — a digital replica of the factory floor — are an important ...

For those monitoring innovation pipelines, patent intelligence is becoming a leading indicator of competitive positioning.

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration fosters the adoption of innovative technologies by pharmaceutical companies. To assist CDER in those efforts, an ...

Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product ...

In this interview, Charles Chase, PhD, the VP and Technical Business Development at Asymchem, a technology-focused pharmaceutical manufacturing company, discusses the significant impact of RNA ...

Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...

EMS is one of the most hands‑on and practical automation systems in pharma. It is simultaneously about engineering, regulatory requirements and operator convenience. Proper architecture (local logic ...