BioPharm International, March 2012 Issue (PDF)
Scale-Up of Human Stem Cells
Scale-up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in a Single-use Bioreactor
Demonstration of large-scale stem-cell scale-up.
Recombinant Albumin Facilitates Formulation Design of Stable Drug Products
Recombinant albumin can stabilize a drug product and assist in API release.
Biosimilar Developers Face a Reference-Product Dilemma
Does global development have to entail multiple comparability studies?
Communications Advances Present Challenges to Manufacturers
Social media use raises questions about applying old standards to new information technology.
The Drive for Best Practice in Biopharmaceutical Manufacturing
Key business considerations when developing biosimilar products virtually.
CMOs Face a Kodak Moment
The evolving bio/pharmaceutical business model poses risk for CMOs.
FDA Guides the Way to Biosimilars in the US
Has the long-awaited guidance answered all of the industry's questions?
Assessing Filling Technologies For Contamination Risk
The authors compare the exposure risk from viable particles from the air supply in four well-established aseptic filling technologies.
Putting Risk-Based Decision-Making Where It Belongs
Focusing on how risk affects the entire organization can improve the business bottom line.
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."
Playing the Drug-Development Game
Key technical considerations when developing a clinical project in the biotech world.
