BioPharm International - Articles on bioprocessing methods, regulatory compliance, and biotech strategies

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Enhancing Tech Transfer
April 29, 2008
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Burrill on Biotech
Biotech Survives Difficult Opening to 2008

Perspectives on Outsourcing
Considerations When Outsourcing the Production of Clinical Material

Disposables Advisor
How to Evaluate the Cost Impact of Using Disposables in Biomanufacturing

Final Word
Validation Failure is Not an Option. Should it be?

SemBioSys Demonstrates Functionality of its Safflower Produced Apo AI(Milano)
June 11, 2008
SemBioSys Genetics, Inc. (Calgary, Canada) has demonstrated that its safflower-produced Apo AI(Milano) is functional in a widely accepted animal model.
Sweeping Changes Ahead for Biotech, Says Ernst & Young
June 11, 2008
The global biotechnology industry achieved record levels in financing and deal making in 2007, as investors and strategic partners showed strong confidence in the sector amid tightening global financial conditions that will continue to test the industry in 2008.
BSPA Roundtable Addresses Disposal of Disposables
June 11, 2008
As the use of disposable bioprocessing equipment has increased, a new question is gaining prominence: What is the best way to dispose of the equipment after use?
USP Updates Guideline for Pending Monographs
June 11, 2008
The US Pharmacopeial (USP) Convention (Rockville, MD) has announced updates to the guideline for its pending monographs approach.
FDA Approves Expanded Adjuvant Indications for Herceptin
May 23, 2008
US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.
FDA Food Protection Plan Shows Significant Progress
FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
FDA Approves Diaphragm-Pacing Device
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Healthcare Reform Threatens Biotech Coverage and Access
Biotech companies fear comparative effectiveness analysis will emphasize product costs over value.
BioPharm International - June 1, 2008
An Underfunded FDA Fights Back
Under fire, FDA is taking steps to regain its stature as an effective science-based regulatory agency.
BioPharm International - May 1, 2008
FDA's Inspection Program Under Scrutiny
The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight
BioPharm International - April 1, 2008
Characterization of anti-HCP Antibodies by 2D-HPLC
May 12, 2008
Asset Management for Growing Biotech Companies
May 9, 2008
Cleaning Validation: On-Site Trials of SpotView(R)
April 14, 2008
Fermentation Process Monitoring: Dissolved Carbon Dioxide
March 1, 2008
Rapid Characterization of Variable Regions of Monoclonal Antibodies by Top-Down Sequencing using Synapt HDMS
January 21, 2008
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