Articles

Afnan: Biopharm: Thinking Too Linearly?

The idea that “the product is the process and the process is the product” can either result in sameness, or true control.
Post Date: 06/13/2012
Author: Ali Afnan, President, Step Change Pharma, Inc.

A Framework for Technology Transfer to Satisfy the Requirements of the New Process Validation Guidance: Part 2

In the life of any drug product, the technology transfer of a process is a complex matter, made more complicated by the new definition of the Process Validation (PV) guidance issued by FDA in January 2011.
Post Date: 05/22/2012
Author: Bikash Chatterjee and Mark Mitchell, Pharmatech Associates

PDA Examines Benefits and Flaws of Single-Use Systems

This year’s PDA Annual Conference paid special attention to the issues posed by use of single-use biopharmaceutical processing equipment.
Post Date: 05/08/2012
Author: Agnes Shanley, Editor in Chief

Potato Chips, Soap Flakes, Biopharm (and Pharma)

Consultant Robert Dream shares thoughts on evolving industries
Post Date: 05/08/2012
Author: Agnes Shanley, Editor in Chief

With a Full Range of Products, EMD Millipore Turns Its Attention to Solutions

The company aims to leverage the expertise it has always had in-house, yet hadn’t fully capitalized on with the pharma industry, says VP Christophe Couturier.
Post Date: 05/02/2012
Author: Paul Thomas, Senior Editor

A Framework for Technology Transfer to Satisfy the Requirements of the New Process Validation Guidance: Part 1

A risk-based model allows the manufacturer to fully consider process and product design at the outset of tech transfer.
Post Date: 04/25/2012
Author: Bikash Chatterjee and Mark Mitchell, Pharmatech Associates

Instrument Tolerances: Manufacturer vs. Process

Using the instrument maker’s tolerance, there is often a higher risk of an “Out of Tolerance” appearing on a calibration certificate; this costs money.
Post Date: 04/11/2012
Author: Michael Boetzkes, Quality Manager, Vaisala

From the Editor: Pangloss or Popper: Has Drug Manufacturing Advanced in the Past Decade?

Can drug manufacturing reach its potential without standards, science and an admission that there’s a need for improvement?
Post Date: 04/11/2012
Author: Agnes Shanley, Editor in Chief

Therapeutic Dose: Reforesting Innovation

Trade show consolidation can be a good thing, at least when it gives smaller innovator companies room to grow.
Post Date: 04/11/2012
Author: Emil W. Ciurczak, Contributing Editor

The Pulse of Pharmaceutical Manufacturing

The big picture has changed very little in ten years. While pointing out root causes, observers also see reasons for optimism.
Post Date: 04/04/2012
Author: Agnes Shanley, Editor in Chief

Raman's New Reach

Allied with other imaging techniques, Raman spectroscopy is being used for more QC, process control, and QbD efforts.
Post Date: 03/14/2012
Author: Agnes Shanley, Editor in Chief

Pfizer: Moving from Centralized to Holistic Supply Chain Security

When it comes to patient safety, says Brian Johnson, there should be no “competitive advantage.”
Post Date: 02/14/2012
Author: Paul Thomas, Senior Editor

Therapeutic Dose: A One-Trick Pony Won’t Carry Continuous Processing

Sometimes, analytical methods, including NIR, just aren’t enough.
Post Date: 02/14/2012
Author: Emil W. Ciurczak, Contributing Editor

Studying Outliers to Ensure Ingredient and Product Quality

Out-of-trend results from APRs offer unique insights into ingredients and finished products.
Post Date: 01/31/2012
Author: Bir (Barry) Gujral and Peter Amanatides, Noven Pharmaceuticals

Imaging the Blending Process

Hyperspectral imaging can be used to optimize blending, by monitoring the distribution of excipients and APIs in formulation.
Post Date: 01/03/2012
Author: Gabor Kemeny and Gina Stuessy, Middleton Research

MedImmune in Frederick: Using Ordinary Tools in Extraordinary Ways

MedImmune’s approach may help take the blame off automation for plant startup delays.
Post Date: 01/03/2012
Author: Paul Thomas, Senior Editor

Therapeutic Dose: Sampling: Good News, Bad News

Changing from the status quo to meaningful testing will satisfy both FDA and ASTM.
Post Date: 01/03/2012
Author: Emil W. Ciurczak, Contributing Editor

Want Better Logistics? Make a Clean Start

Pharmaceutical manufacturers consistently spend too much on downstream logistics services. Clean sheet modeling helps them plan networks around real costs, rather than historical precedents.
Post Date: 11/30/2011
Author: Knut Alicke, Raoul Dubeauclard, Martin Lösch and Michael Schmeink, McKinsey &...

Therapeutic Dose: Fractal Pharma

When the whole so closely resembles the individual parts, where is the big picture, or the path to continuous improvement?
Post Date: 11/15/2011
Author: Emil W. Ciurczak, Contributing Editor

Solvent Recovery at Pfizer: A Continuous Solution for Small Waste Streams

When equipment and processes challenge solvent recovery for small-volume streams, an atypical approach is needed, says Pfizer’s Frank Urbanski.
Post Date: 11/09/2011
Author: Paul Thomas, Senior Editor