Articles

Tech Transfer Risk

Alkermes’ proven risk-analysis rubric assures healthier, more profitable partnerships by requiring companies to analyze the technical and business risks.
Post Date: 02/07/2013
Author: Paul Hurley, Associate Director, Product Development and Scale-Up, Alkermes ...

Breaking the Biotech Bottleneck

Downstream capacity still lags behind upstream, but shortages are now “acute” rather than “chronic”
Post Date: 01/07/2013
Author: Eric Langer, BioPlan Associates

Ask the Right Stats Questions to Find the Best Statistics Tools

Once you know what the objective is and what the need is, you can figure out which tools can help meet your objectives
Post Date: 12/18/2012
Author: Ronald D. Snee, PhD, Snee Associates

Therapeutic Dose: How I was Shanghaied (and Surprised)

Watch out. Asian pharma professionals are serious about learning how to do PAT and QbD
Post Date: 12/18/2012
Author: Emil Ciurczak, Contributing Editor

Holiday Inspiration from Takeda's EVP, Tadataka Yamada

Become partners with emerging markets, in the broadest sense, he said, and always support, and embrace, revolutionary, rather than evolutionary change.
Post Date: 12/11/2012
Author: Agnes Shanley, Editor in Chief

Reviewing the Basics of Stats

A quick check of the fundamentals will help you approach manufacturing analytics with the right statistical mindset.
Post Date: 12/03/2012
Author: Kate DeRoche Lusczakoski, Ph.D., and Aaron Spence, M.A., Aegis Analytical

Using Quality by Design to Optimize Tech Transfer of a BFS Process

Catalent worked within the QbD framework to help a customer transfer a new blow-fill-seal (BFS) process.
Post Date: 11/14/2012
Author: Norman Weichbrodt and Mike Camalo, Catalent Pharma Solutions

Trouble Shooting Depth Filtration

Some common scenarios (and their root causes)
Post Date: 10/03/2012
Author: Brittany Nixon, 3M Purification

Tracing NIR's Trajectory for Bioprocess Monitoring

By better combining and interpreting readily available data, biomanufacturing experts are improving control of fermentation and other processes, says Sartorius’ Roland Bienert.
Post Date: 10/02/2012
Author: Paul Thomas, Contributing Editor

Trust, but Verify (Continuously)

FDA’s Process Validation guidance calls for continuous process verification. Here’s how to do it, and how automation can help.
Post Date: 09/25/2012
Author: Heather Schwalje, Emerson Process Management

Quantifying Breakeven Point with Contingencies

Suggestions for bias-free “go/no-go” decision-making.
Post Date: 09/20/2012
Author: Dan Collins

Tracing NIR’s Trajectory for Bioprocess Monitoring

By better combining and interpreting readily available data, biomanufacturing experts are gaining better control of fermentation and other processes, says Sartorius’ Roland Bienert
Post Date: 09/12/2012
Author: Paul Thomas, Senior Editor

Tracing NIR’s Trajectory for Bioprocess Monitoring

By better combining and interpreting readily available data, biomanufacturing experts are gaining better control of fermentation and other processes, says Sartorius’ Roland Bienert.
Post Date: 09/11/2012
Author: Paul Thomas, Senior Editor

Are Your Validation Efforts Based on Sound Process Design?

Process design is the key to effective validation
Post Date: 09/05/2012
Author: Parveen Bhandola, Ph.D.

Estimating Risk-Based Cost and Contingency

How to Apply Monte Carlo Simulation to Engineering Capital Projects
Post Date: 09/05/2012
Author: Keith Melchiors

Soaring Innovation, Grounded Goals

Readers recognize tools that break new ground but promise to improve efficiency
Post Date: 08/15/2012
Author: Paul Thomas, Senior Editor

On-Demand: Ensuring Pharmaceutical Product & Process Quality with Spectrometric Methods

More than 20 on-demand webcast presentations from industry experts and leading solutions providers. NIR, Raman and Particle Characterization technologies and applications that are improving pharmaceutical product and process quality.
Post Date: 08/06/2012
Author:

PharmaView: Single-Use Standards: What’s the Rush?

Can standardization and innovation coexist?
Post Date: 08/06/2012
Author: Paul Thomas, Senior Editor

Tailoring Production to Demand at Pfizer

The company’s manufacturing facility in Freiburg, Germany, uses an approach that maximizes flexibility and segmentation
Post Date: 08/01/2012
Author: Colin Seller, Pat Field, Dr. Andreas Werner, Gereon Schepers, Frank Lesmeister

A Practical & Structured Approach To Deploying Process Analytical Technology In a Manufacturing Environment

Let’s redefine PAT as the Practical Application of Technology
Post Date: 07/31/2012
Author: Martin Gadsby, Director, Optimal Industrial Automation Ltd