Quality by Design

Lyophilization: How to Meet Scale-Up Challenges Using QbD

July 02, 2012

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

35th Anniversary Special: Reader Views on Changes in Pharmaceutical Manufacturing

July 02, 2012

Readers point to quality by design as having a significant influence on manufacturing and drug development during the past decade.

Atypical Visible Particles

July 02, 2012

An industry roundtable on how users and makers can best assess and manage black specks.

Bioprocessing Trends: Annual Survey Results

May 01, 2012

Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey.

Q&A with Chris Meissner, Meissner Filtration Products

March 02, 2012

A Q&A with Chris Meissner, president of Meissner Filtration Products, on recent industry trends.

Advancing Unit Operations for Continuous Processing in Solid-Dosage Manufacturing

March 01, 2012

The article examines some recent developments for this process step and for continuous manufacturing overall.

An Enhanced Approach to Drug-Substance Development and Manufacture

February 02, 2012

FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.

Inside ICH: ICH Implementation Support

February 02, 2012

ICH Q8, Q9, and Q10 support and implications for the future.

Q&A with Gilles Cottier, SAFC

January 02, 2012

A Q&A with Gilles Cottier, president of SAFC, on recent industry trends.

Water-Intrusion Test Integration

November 02, 2011

The authors describe the operational qualification of test accuracy with regard to temperature drift using a thermal-compensation algorithm on several freeze dryers.