BioPharm International, March 2012 - BioPharm International

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BioPharm International, March 2012
Features
Scale-up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in a Single-use Bioreactor
By Daniel Kehoe , Aletta Schnitzler , Janice Simler , Anthony DiLeo , Andrew Ball
Demonstration of large-scale stem-cell scale-up.
Recombinant Albumin Facilitates Formulation Design of Stable Drug Products
By Mark Perkins
Recombinant albumin can stabilize a drug product and assist in API release.
Assessing Filling Technologies For Contamination Risk
By Benoît Verjans , Charles H. Reed
The authors compare the exposure risk from viable particles from the air supply in four well-established aseptic filling technologies.
A 25-Year Retrospective on the Public's Perception of the Biopharmaceutical and Biotech Industry
This month, we rewind to an article titled "Demystifying the New Biology."
From the Editor
FDA Guides the Way to Biosimilars in the US
By Angie Drakulich
Has the long-awaited guidance answered all of the industry's questions?
Regulatory Beat
Communications Advances Present Challenges to Manufacturers
By Jill Wechsler
Social media use raises questions about applying old standards to new information technology.
Perspectives on Outsourcing
CMOs Face a Kodak Moment
By Jim Miller
The evolving bio/pharmaceutical business model poses risk for CMOs.
Compliance Notes
Putting Risk-Based Decision-Making Where It Belongs
By Greg T. Plante
Focusing on how risk affects the entire organization can improve the business bottom line.
Boot Camp Business Guide
The Drive for Best Practice in Biopharmaceutical Manufacturing
By Anjan Selz
Key business considerations when developing biosimilar products virtually.
Boot Camp Tech Guide
Playing the Drug-Development Game
By Paul Nelles
Key technical considerations when developing a clinical project in the biotech world.
Final Word
Biosimilar Developers Face a Reference-Product Dilemma
By Fiona Greer
Does global development have to entail multiple comparability studies?

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