Articles

Industry Thought Leaders Share Visions and Lessons about Quality for Innovation and Continuous Process Improvement


Post Date: 10/28/2011
Author: Justin O. Neway, Ph.D.

From the Editor: Entropy: Can the Center Hold at Your Facility?

Operations, like natural systems, are drawn to chaos. Only energetic management can stop the slide.
Post Date: 10/24/2011
Author: Agnes Shanley, Editor in Chief

Control Cross-Contamination Risk with HAPIs: Using a Risk-MaPP Master Matrix

How Alkermes implemented Risk-MaPP to maximize operator and patient safety.
Post Date: 10/12/2011
Author: Mark O’Reilly and Aisling Horan, Alkermes

Managing Pharma Supply Networks in Emerging Markets

Before rushing to sources in emerging markets, do you have the right long-term strategy, partners, and resources for managing the partnership?
Post Date: 10/12/2011
Author: Vikas Bhadoria and Jaidev Rajpal, McKinsey & Company

Demand for Innovation: Disposable Devices Top the List in 2011

The demand for improvements in single use, disposable bioprocessing equipment have shot to the top of end-users’ wish list of better, more innovative products in 2011.
Post Date: 10/11/2011
Author: Eric S. Langer, President, BioPlan Associates

Closed System Control: From Defense to Pharma

Authors from Pfizer and Rockwell Automation propose a closed-control scheme for pharmaceutical PAT.
Post Date: 10/04/2011
Author: David A. March, Rockwell Automation, and Wentao Wang, Pfizer

Afnan: Scientific Sampling

Process knowledge demands a very different approach to sampling.
Post Date: 10/04/2011
Author: Ali Afnan, PhD, Principal, Step Change Pharma, Inc.

Therapeutic Dose: Problems in Pharma? Time to Examine the Rules

Enforcing existing laws is a start.
Post Date: 09/28/2011
Author: Emil W. Ciurczak, Contributing Editor

Sorry, Agnes. Pharmaceutical Pricing <i>Does</i> Follow the Laws of Supply and Demand

Reader response from last month's Editor's letter.
Post Date: 08/17/2011
Author:

Exploring Fluorescence as an Online PAT Solution

Mike Ponstingl, owner of Custom Sensors & Technology, shares insight into new methods of monitoring fermentation and other bioprocesses.
Post Date: 08/02/2011
Author: Paul Thomas, Senior Editor

Afnan's Letter from Japan: Japanese Pharma's Embracing PAT, QbD and Opex Tools

As its auto industry has done, Japan pharma may demonstrate that a cheaper manufacturing base is not necessarily the solution to our problems.
Post Date: 08/02/2011
Author: Ali Afnan, Principal, Step Change Pharma, Inc.

Managing Change Management in Pharma: A Talk with Bill Wilder

People generally don’t resist change, says the Life Cycle Institute's Bill Wilder. “They resist being changed when they don't know why.”
Post Date: 07/27/2011
Author:

Therapeutic Dose: Facilius per Partes in Cognitionem Totius Adducimur

We are more easily led part by part to an understanding of the whole. –Seneca
Post Date: 07/20/2011
Author: Emil W. Ciurczak, Contributing Editor

Chatterjee: How Much is Enough? API Quality Assurance and the New Process Validation Guidance

The challenge all quality professionals face is answering the question, “How much is enough?”
Post Date: 07/20/2011
Author: Bikash Chatterjee, President and CTO, Pharmatech Associates

PharmaView: Shattered Trust in Manufacturing and FDA, a Renewed Faith in the Press

A Milwaukee newspaper reminds an industry of its flaws.
Post Date: 07/12/2011
Author: Paul Thomas, Senior Editor

Afnan: Will Biopharma Dare to be Innovative?

Three-to-four-month flu vaccine manufacturing cycles are within reach.
Post Date: 06/27/2011
Author: Ali Afnan, Contributing Editor

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.

PharmaView: Can RFID Make Waves Again?

Reports of the demise of radio frequency identification as a breakthrough supply chain technology have been greatly exaggerated.
Post Date: 06/14/2011
Author: Paul Thomas, Senior Editor

Beyond the Mandates: Finding Business Value in Mass Serialization and Supply Chain Visibility

Tunnell Consulting’s Carla Reed provides a six-step approach for establishing drug products’ digital DNA, with an eye towards ROI as well as compliance.
Post Date: 06/08/2011
Author: Carla Reed, Principal, Tunnell Consulting

Manufacturing Drives Value In Biopharmaceuticals

Long-term success in biopharma will hinge on the technical and commercial decisions companies make today.
Post Date: 06/01/2011
Author: Marco Ziegler and Alberto Santagostino, McKinsey & Co.