Mike Auerbach

Liquid-Filled Capsules: From Niche to Mainstream
Liquid-filled capsules are no longer a specialized workaround but a technically sophisticated platform that demands deliberate alignment among formulation design, manufacturing capability and quality strategies. read more
Digital, Continuous and Data-Rich
Advances in technologies, data, and development strategies are reshaping how oral solid dosage drugs are designed and manufactured, with a clear emphasis on lowering cost, shortening timelines, and improving quality and ... read more
What’s Next for Tableting?
Speed-to-market, efficiency, flexibility, quality. These aren’t just buzzwords — they’re critical goals every pharma manufacturer must achieve to bring new therapies to patients. The challenge lies in how to reach them. read more
Taking on bRo5 Compounds
Beyond Rule of Five compounds were once considered unlikely to demonstrate oral bioavailability. This article examines what bRo5 drugs are, how they are formulated, and the modern manufacturing considerations for developing them ... read more
Particle Size Control: Balancing Solubility, Safety and Regulatory Compliance
As more potent and complex small molecules enter development, manufacturers face growing challenges in formulating them into effective oral drugs. Central to these hurdles is particle size control — a key factor influencing ... read more
Modern Cleaning Validation: Ensuring Safety and Quality in Today’s OSD Production
Today, cleaning validation is a multifaceted process that integrates risk assessment, analytical chemistry, microbiology, and quality systems. Modern approaches focus on developing cleaning processes that are not only effective ... read more
The Future of Pharma Capsules
The pharmaceutical capsule industry is experiencing a renaissance, driven by technological advancements, evolving patient needs and stringent regulatory requirements. From AI-driven filling machines to vegan capsule alternatives, ... read more
Titanium Dioxide: The White Pill Dilemma
Titanium dioxide has long been a crucial excipient in pharmaceutical tablets, serving as an opacifier and white colorant. However, recent developments have raised concerns about its safety and prompted a search for alternatives. read more