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2009 BIO Convention

View BioPharm's vidcasts live from BIO 2009
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From the Editor
The Ups and Downs of the FDA Budget

Disposables Advisor
User Viewpoints on Disposables Implementation

Perspectives on Outsourcing
Criteria for Selecting a CMO: A Case Study

Final Word
Biological Potency Assays are Key to Assessing Product Consistency

Genzyme Recalls Fabrazyme 5 mg
June 30, 2009
Genzyme has voluntarily recalled all remaining stock of Fabrazyme 5 mg (agalsidase beta), with batch numbers A8049H04 and A8060H01.
OctoPlus Opens New GMP Manufacturing Facility
June 24, 2009
OctoPlus has started production in its new manufacturing facility in Leiden.
Vetter Installs Six Automatic Packaging Lines at its New Facility
June 19, 2009
Vetter Pharma International (Ravensburg, Germany) has completed the installation of six automatic packaging lines at Vetter Secondary Packaging (VSP), the company?s new packaging services facility.
Genzyme Detects Virus Contamination of Bioreactor, Halts Production
June 17, 2009
Genzyme Corporation has halted production at its manufacturing plant in Allston Landing, MA, because it has detected a virus that impairs cell growth in one of the six bioreactors there.
Three Shared Audit Models Tested at Rx-360 Consortium's Launch Meeting
June 17, 2009
The newly formed Rx-360 consortium had an impressive turnout of over 125 people at its launch meeting in Washington, DC, on June 5.
FDA Approves Multaq to Treat Heart Rhythm Disorder
FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban
FDA Seeks Public Input on Tobacco Regulation
FDA Confirms E. Coli O157:H7 in Prepackaged Nestlé Toll House Refrigerated Cookie Dough
U.S. Attorney News Release: Ringleader Sentenced to Nine Years In Federal Prison For Allergy Testing Health Care Fraud Scheme That Bilked Insurance Companies and Deceived Thousands of Patients

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Bio Pharm Now
Click to listen to the Podcast Series
Keith Webber, PhD, Deputy Director of the Office of Pharmaceutical Science, CDER, FDA discusses how product specifications for biological products apply to individual samples or averages; the use of specifications vs. control limits; stability results, and more.
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Stiffer Enforcement at the FDA
Agency officials promise swift action against violators of drug safety and quality regulations.
BioPharm International - June 1, 2009
Comparative Effectiveness Research to Shape Biotech Studies
Authorities are pushing for CE; manufacturers prefer to focus on value.
BioPharm International - May 1, 2009
Food and Drug Safety Crises Prompt White House, Congressional Action
The FDA is poised to gain more authority and resources to ensure product quality.
BioPharm International - April 1, 2009
 

Webcasts

Chiral Analysis and Purification
Sponsored By Thar Instruments

No More Tiers! A new Approach for Evaluating Formulary Contracts
Sponsored By Amundsen Group and Wolters Kluwer Health

Revolutionizing KOL Relationship Management for Maximum Impact
Sponsored By Cegedim Dendrite

Purification of Murine IgG1 Using UNOsphere S and CHT Ceramic Hydroxyapatite Chromatography
June 23, 2009
Purification of a Monoclonal Antibody Using a Combination of UNOsphere Rapid S and UNOsphere Q Media Ion Exchange Chromatography After Protein A Capture
June 23, 2009
Lancaster Labs develops extractables database for LC/MS analysis
May 15, 2009
In-Vivo Spectroscopy of Human Tissue: Skin and Cartilage
May 13, 2009
Fermentation Process Monitoring II: Mammalian Cell Culture
April 1, 2009
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