Drug Development

Antonello Barresi is Professor of Process Design and Development at Politecnico di Torino.

Articles

The same recipe obtained in laboratory-scale equipment cannot, without modifications, generally be used to freeze-dry the product in a pilot-scale or industrial-scale freeze-dryer.

Overcoming Common Lyophilization Scale-Up Issues

Getting an answer is easy-asking the right question is apparently more difficult.

All the Wrong Questions

Sometimes, there are just too many cooks in the kitchen.

Quality Overload

Common Sense Required

In any industry, inspections can be a pain, and pharma is no exception.

Inspections Gone Mad

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The need for greater process understanding raises the bar for suppliers.

A QbD World for Suppliers

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi,  Tel. +91.9650770650, asrathore@biotechcmz.com.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Quality by Design for Biologics and Biosimilars

Just when things seem to be looking up, the unexpected problem occurs.

One Step Forward, Two Steps Backward

Taking care to note, file and re-check information can save one from future mishaps.

Looking in All the Right Places

The authors highlight the need for a technology-transfer process that is efficient, cost-effective, and repeatable, stressing the importance of process understanding. Read this and other preferred organization articles in this special issue.

Process and Scaling