BioPharm International, June 2008 - BioPharm International

ADVERTISEMENT

ADVERTISEMENT

BioPharm International, June 2008
Features
Modeling of Biopharmaceutical Processes—Part 1: Microbial and Mammalian Unit Operations
By Anurag S. Rathore, PhD , Ken Green , Yas Hashimura , Greg Nyberg
Process-modeling tools can ensure smooth tech transfer.
Avoiding the Pain of Out-of-Specification Results
By Brian K. Nunnally, PhD , Deedra F. Nunnally , John S. McConnell
Improving your quality operations by using sound statistical principles.
A Rational Approach for Setting and Maintaining Specs for Biological and Biotech–Derived Products—Part 1
By Izydor Apostol, PhD , Timothy Schofield , Gerhard Koeller, PhD , Susan Powers, PhD , Mary Stawicki , Richard A. Wolfe, PhD
A staged approach to limits should embrace future capabilities.
Columns and Departments
Healthcare Reform Threatens Biotech Coverage and Access
By Jill Wechsler
The comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies.
Funding the FDA, Finally
By Laura Bush
A stronger FDA will benefit both the industry and the public. And it now looks like we are starting down a path to build up that strength.
Validation Failure is Not an Option. Should it be?
By Stephan Krause, PhD
The industry needs to open up to validation failures.
The Power of Hypothesis
By Steven Walfish
How to use hypothesis correctly, and understanding the difference between one-sample, two-sample, and z-test.
How to Evaluate the Cost Impact of Using Disposables in Biomanufacturing
By Andrew Sinclair
The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis.
Biotech Survives Difficult Opening to 2008
By G. Steven Burrill
Following the market crisis of the first quarter of 2008, biotech IPOs and financing are down, but partnering continues, and mergers and acquisitions (M&As) remain hot.
Considerations When Outsourcing the Production of Clinical Material
By Josée Ethier , Chantal Déziel
It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.

ADVERTISEMENT

ADVERTISEMENT

Click here