BioPharm International, December 2008 - BioPharm International

ADVERTISEMENT

ADVERTISEMENT

BioPharm International, December 2008
Features
How to Make the Business Case for Quality by Design
By Justin Neway, PhD
No time for QbD? How to convince management to make it a priority.
QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1
By Anurag S. Rathore, PhD , Azita Saleki-Gerhardt , Stephen H. Montgomery , Stephen M. Tyler
Using multivariate experiments to define acceptable ranges.
Antibody Purification Using Membrane Adsorbers
By Leonardo Giovannoni, PhD , Marco Ventani , Uwe Gottschalk, PhD
Results from a process developed for a commercial antibody.
Columns and Departments
How to Avert Supply-Chain Quality Failures
By Matthew Kopecky
To stave off quality issues associated with production processes, a centralized and enterprise-wide quality management initiative must be enforced.
Regulation of Biomarker Clinical Laboratory Tests Used in Personalized Medicine
By Paul Radensky
A clear oversight framework for biomarker clinical laboratory tests used in personalized medicine is required.
Big Changes Ahead for Biotech Manufacturers
By Jill Wechsler
To expand coverage amidst the economic crisis, Obama will be looking hard for ways to cut healthcare costs.
The Case for Outsourcing Biologics Process Development
By Stephanie Morris
Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.
Will The Biotech Industry Survive The Financial Crisis?
By G. Steven Burrill
The meltdown in the financial markets represents a sea change in the world of financing that will continue to affect the flow of much needed capital into the sector for the foreseeable future.
The New Era of Process Validation
By Laura Bush
The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.
Indian Biopharmaceutical Industry: 2008 in Review
By Eric S. Langer
A closer look at the past year's development in India.
Disposable Technologies Implementation: Understanding and Managing Risks
By Andrew Sinclair , Miriam Monge
In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.

ADVERTISEMENT

ADVERTISEMENT

Click here