BioPharm International, July 2006 - BioPharm International

ADVERTISEMENT

ADVERTISEMENT

BioPharm International, July 2006
Featured Article
Peak Shape Calibration Method Improves the Mass Accuracy of Mass Spectrometers
By Don Kuehl , Yongdong Wang
A novel calibration approach was developed that not only calibrates the X-axis, but also calibrates the peak shape.
Articles
Getting the Most from Your CMO Relationships: A Life Cycle Approach
By Todd Applebaum
Many CMO relationships are established while a product is early in clinical or preclinical development.
Disposables: A Solution for Efficient Biopharmaceutical Production
By Hélène Pora
Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.
Taking Control of Your Quality Control
By George Rodriques
Federal regulations are broad and open to interpretation. Most have not caught up with advancements in technology.
Columns and Departments
Legal Forum: Literal Claim Scope and After-Arising Technologies
By Judy M. Mohr, PhD
The courts regard biotechnology as highly unpredictable
StreetTalk: The Buffett Way 2006
By Brian O'Connell
Buffett prefers to buy small, publicly traded companies with ample room for growth.
Regulatory Beat: Nanotechnology Presents Opportunities and Challenges for FDA and Manufacturers
By Jill Wechsler
Food and Drug Administration is encouraging public–private collaborations to more fully explore the physical and chemical characteristics of nanoparticles.
Outsourcing: Nonclinical Development Becoming a Big Business
By Jim Miller
The lack of biomanufacturer acquisitions seems surprising.
Test article
By Laura Bush
This is just a lovely test of how we post articles in HTML.
Final Word: Using Molecular Tools for Biopharmaceutical Quality Control and Plasmid DNA
By W. Alan Moore
For decades now, it has been said that "the process is the product" for biologics. Great care and consistency must be applied in their upstream manufacture—during fermentation, harvest, and early purification—to preserve their complex structure, which confers their activity and specificity. As the product moves to late-stage purification, however, the relative concentration of impurities and altered product forms is diminished. Also, the final dosage form of most large molecule biopharmaceuticals is the relatively simple liquid formulation of parenteral dosage form. In contrast, manufacturing the solid dosage forms common for small-molecule drugs involves more complex processes, such as mixing dry powders, granulation, manufacturing controlled-release matrices, and tableting.
From the Editor in Chief: A Shot In The Arm
By Laura Bush
The approvals of two groundbreaking vaccines in the last month is encouraging news. Vaccines have long been undervalued because they haven't been as profitable as other pharmaceuticals. So it's good to see them getting deserved attention that goes beyond fears of flu outbreaks.

ADVERTISEMENT

ADVERTISEMENT

Click here