Articles

Biomanufacturing Morphs

In biopharma, budgets are returning and manufacturers are emphasizing innovation, productivity, and cost control.
Post Date: 06/14/2011
Author: Eric S. Langer, President, BioPlan Associates, Inc.

Looking for Supply Chain Answers in 2011

Interest in protecting the drug supply chain is becoming top of mind for drug manufacturers, technology providers, and governments as they begin to understand the current and elevated risks to patient safety.
Post Date: 04/25/2011
Author: Ken Appel, Manager of Regulated Markets, Vaisala

Biotech Production: Planning, Scheduling and Throughput Analysis with a Combined Theory of Constraints, Lean and Simulation Approach

A major biotech company's only final stage bio-manufacturing facility in the world was struggling to meet rapidly increasing customer demand. Unanticipated production delays and frequent starvations at critical parts of the operation were causing not only late and missed deliveries, but also the expiration of ...
Post Date: 07/22/2010
Author:

PDA 2010: Stopper Sensibility

At PDA 2010, lyophilization experts debate issues that confound them and compromise product and vial integrity.
Post Date: 03/23/2010
Author: Paul Thomas, Senior Editor

Bringing More Science to Tableting

Last month brought news of resources and newer techniques being brought to bear on tableting.
Post Date: 03/22/2010
Author:

Taking the Plunge to Harmonize Pharmaceutical Regulations

Within the past five years, more of world's regulatory agencies and pharmacopeias have gotten on the same wavelength.
Post Date: 03/04/2010
Author: Agnes Shanley, Editor in Chief

Getting More Scientific About Tableting

Last month brought news of resources and newer techniques being brought to bear on tableting.
Post Date: 02/23/2010
Author:

From the Editor: Ordinary Measures

Everything I needed to know I learned in Freshman Chemistry 101
Post Date: 02/02/2010
Author: Agnes Shanley, Editor in Chief

Are Biosimilars Bound for No Man’s Land?

Follow-on biologics regulation could stifle the innovation that defines and drives the biopharmaceutical industry, say two of Deloitte’s leading experts in the area.
Post Date: 01/05/2010
Author: Paul Thomas, Senior Editor

Webcast: A Look Ahead: The Impact of Biosimilars on the Pharma Landscape

Follow-on biologics, or biosimilars, will soon become reality in the U.S. Given their inherent complexity and the current state of analytics, how will their safety and quality be ensured? Will they boost or diminish competition and innovation in biotech? Join us for a thought-provoking presentation and panel ...
Post Date: 12/15/2009
Author:

Flexible Pharma: Puzzling Out the Plant of the Future

The need to improve agility and reduce financial risk is driving new approaches to plant design and operation, and the use of new technologies. Industry experts look at the future pharmaceutical plant from all angles.
Post Date: 11/30/2009
Author: Agnes Shanley, Editor in Chief, with Paul Thomas, Senior Editor

From the Editor: Excipients: Out of Sight, Not Out of Mind

Questions of QbD, supply chain management, anticounterfeiting and adverse reactions cannot end with the formulation or active ingredient. PAT will be essential
Post Date: 05/13/2009
Author: Agnes Shanley, Editor in Chief

Low-Risk Lyophilization

Developing a successful lyophilization program requires equal parts design, technology, and expertise.
Post Date: 03/16/2009
Author: Brian Bucur, Associate Director, Lyophilization & Sterilization and Timothy ...

Interphex Stands Test of Time (and Economy)

Despite a tough economy, few question the value of attending Interphex, and this year’s show promises to be as good as ever.
Post Date: 02/05/2009
Author: Paul Thomas, Senior Editor

Living the Biopharma Dream in Lincoln

Nebraska-Lincoln has built it, but will they come to this state-of-the-art bioprocessing facility?
Post Date: 12/17/2008
Author: Paul Thomas, Senior Editor

Product Spotlight: Newest DeltaV, a Sneak Peak

Ease of use, cybersecurity and batch management improvements are the focus of Emerson’s latest process control offering
Post Date: 10/16/2008
Author:

e-Pedigrees: Change During a Time of Uncertainty

<P>A view of the future from Todd Applebaum, VP of Strategy and Operations Practice at Maxiom Group <a href="http://www.maxiomgroup.com/" target="_blank">(www.maxiomgroup.com)</A></P>
Post Date: 10/02/2008
Author: Agnes Shanley, Editor in Chief

From the Editor: e-Pedigrees: A Little Less Conversation (and a Little More Action, Please)

All this inactivity can’t be a good thing.
Post Date: 09/23/2008
Author: Agnes Shanley, Editor in Chief

Weak Links

A recent survey suggests that manufacturers don’t have as much control over supply chain security as they think they do.
Post Date: 09/03/2008
Author: Carla Reed, Marsh Inc.

Vaccine Manufacturing Déjà vu: A 483 Review

Noncompliance appears to focus on the same issues: inadequate SOPs, root cause analysis and CAPA
Post Date: 06/24/2008
Author: Agnes Shanley, Editor-in-Chief