Continuous Manufacturing for Solid-Dosage Drug Production

Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.

This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.

Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.

This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.

FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.

Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.

Jason Bertola, executive director of Commercial Development for the Advanced Synthesis Platform at Lonza in North America, explains the demand for spray drying and the hurdles involved with scale up, in an interview with PharmTech.

Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.