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BioPharm International-10-01-2012
BioPharm International
BioPharm International, October 2012 Issue (PDF)
October 01, 2012
Issue PDF
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Vaccine Packaging and Delivery Systems
India Enforces Stricter Patent Laws
October 01, 2012
Global Reports
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India has enforced stricter patent laws compared to other countries. For a drug to be patentable in India, the invention has to be novel, inventive, and industrially applicable.
A Manufacturing-Capacity Sharing Model
October 01, 2012
Features
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The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."
FDA and the Importance of Confidentiality
October 01, 2012
Final Word
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Do you have to worry about FDA releasing confidential data? Apparently so.
New Era for Generic Drugs
October 01, 2012
Regulatory Beat
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User fees aim to speed approvals and support inspections.
Discovery Pipeline: Nanoparticles for Targeted Delivery
October 01, 2012
Global Reports
25
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Recently published research demonstrates how nanoparticles can be used to overcome hurdles in localized drug delivery.
Considerations in Vaccine Packaging and Delivery Systems
October 01, 2012
Features
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Glenn Thorpe of West Pharmaceutical Services gives an update on packaging and delivery methods for vaccines.
Sizing the Market for Contract Manufacturing
October 01, 2012
Perspectives on Outsourcing
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Measuring the size of the market for contract manufacturing services requires a careful hand.
Bringing Innovation to Neglected Disease R&D
October 01, 2012
Features
25
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A new report highlights the industry's contributions to neglected diseases and calls for further collaboration.
Recent Therapeutics IPOs Outshine Market, but Performance Mixed for Broader Life-Sciences Issues
October 01, 2012
Burrill on Biotech
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A handful of therapeutics have performed extremely well in 2012, but as a whole, life-sciences are still down from 2010.
Vaccine Packaging at the Clinical Interface of Vaccine, Healthcare Worker, and Patient
October 01, 2012
Features
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Packaging vaccines using prefilled syringes can increase dosing efficiency, reduce costs, and improve patient safety. This article is part of a special section on vaccines.
Meeting Challenges for Analysis of Antibody-Drug Conjugates
October 01, 2012
Bioanalytical Best Practices
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The complex structure of ADCs necessitates different analytical strategies than those for either small molecules or unconjugated monoclonal antibodies.
Downstream Processing: A Primer
October 01, 2012
Boot Camp Technical Guide
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NIBRT's Ian Nelligan on what to expect when starting a downstream process.
USP Further Strengthens Quality Standards for Heparin
October 01, 2012
Inside USP
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USP optimizes identification tests and impurities procedures.
Key Considerations in Biosimilars Development
October 01, 2012
Features
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Understanding opportunities and challenges across all major phases of development.
Partnerships Remain Crucial to Future Development
October 01, 2012
Guest Editorial
25
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Working together affords many unseen opportunities for pharmaceutical innovation.
Will the next US President support R&D?
October 01, 2012
From the Editor
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Will the next US President support the backbone of our industry?
Considerations in Outsourced Vaccine Manufacturing
October 01, 2012
Features
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Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.
Moisture Matters in Lyophilized Drug Product
October 01, 2012
Analytical Best Practices
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Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.
Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations
October 01, 2012
Features
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MIT survey results address product and site characteristics that statistically correlate with quality performance.
A 25-Year Retrospective on Cleanroom Management
October 01, 2012
Features
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Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management."