BioPharm International, April 2010

Features

A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass Vials

By Xiaochun Yu, PhD , Don DeCou, PhD , Derek Wood , Steven Zdravkovic , Heather Schmidt , Laurie Stockmeier , Robert Piccoli, PhD , Daniel Rude , Xiaoya Ding, PhD

A systematic approach facilitates formulation component selection.

Applying Computational Fluid Dynamics Technology in Bioprocesses-Part 1

By Zhiwu (David) Fang

Computational fluid dynamics is a powerful tool to optimize processes.

Developing a MAb Aggregate Removal Step by High Throughput Process Development

By Gustav Rodrigo , Kristina Nilsson-Välimaa

HTPD allows rapid screening of chromatographic parameters.

Regulatory Beat

REMS Raise Concerns for Biotech Products

By Jill Wechsler

The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.

From the Editor

Preparing For an Uncertain Future

By Laura Bush

Given today's challenges, traditional strategies were bound to change. Now, there is one more big threat (or opportunity?) on the horizon.

Final Word

Better Times Ahead for Biotech

By James C. Greenwood

This year's BIO International Convention will be occurring against a backdrop of profound change in our industry.

Burrill on Biotech

Biotech on a Roll to Start 2010

By G. Steven Burrill

As the capital markets in the US and globally continue to strengthen, the biotech industry can expect to see a rise in initial public offerings this year.

Outsourcing Insights

Complex Clinical Trials are Posing New Challenges Across the Clinical Supply Chain

By Jim Miller

The ability to deal with the complexity of the clinical supply process has shifted the balance of power to clinical supply chain specialists.