BioPharm International, September 2008 - BioPharm International

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BioPharm International, September 2008
Features
Plasmid DNA Recovery Using Size-Exclusion and Perfusion Chromatography
By Miladys Limonta Fernández , Gabriel Márquez , Isabel Rey , Martha Pupo , Odalys Ruiz Hernández , Yalena Amador-Canizares , Santiago Duenas-Carrera
Scalable method to recover plasmid-DNA.
Viral Clearance Strategy Using a Three-Tier Orthogonal Technology Platform
By Suma Ray, PhD , Klaus Tarrach
How to implement a risk-based approach to eliminating viruses.
Columns and Departments
The Company at the Crossroads. Part 1: To Commercialize or Not?
By Joseph J. Villafranca, PhD , Conrad J. Heilman, Jr., PhD , Siddharth J. Advant, PhD
Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.
The Outlook for Quality by Design
By Laura Bush
The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.
The Art of the Deal
By Jim Miller
Risk mitigation should be a key aspect of any contract manufacturing organization's business strategy.
Minimizing the Problem of OOS
By Steven Walfish
Statistical methods for calculating confidence intervals, tolerance intervals, and capability analysis to reduce out-of-specification situations.
Protecting Patents for Personalized Medicine
By Michael J. Shuster , Pauline Farmer-Koppenol
There are several challenges associated with protecting patents for personalized medicines.
Global Manufacturing Challenges Industry Regulators
By Jill Wechsler
The heparin debacle and other crises involving imported drugs and biologics has put pressure on the US FDA to step up its oversight of foreign drug manufacturing.

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