BioPharm International, October 2012 Issue (PDF)
Vaccine Packaging and Delivery Systems
India Enforces Stricter Patent Laws
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
The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."
FDA and the Importance of Confidentiality
Do you have to worry about FDA releasing confidential data? Apparently so.
New Era for Generic Drugs
User fees aim to speed approvals and support inspections.
Discovery Pipeline: Nanoparticles for Targeted Delivery
Recently published research demonstrates how nanoparticles can be used to overcome hurdles in localized drug delivery.
Considerations in Vaccine Packaging and Delivery Systems
Glenn Thorpe of West Pharmaceutical Services gives an update on packaging and delivery methods for vaccines.
Sizing the Market for Contract Manufacturing
Measuring the size of the market for contract manufacturing services requires a careful hand.
Bringing Innovation to Neglected Disease R&D
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
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
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
The complex structure of ADCs necessitates different analytical strategies than those for either small molecules or unconjugated monoclonal antibodies.
Downstream Processing: A Primer
NIBRT's Ian Nelligan on what to expect when starting a downstream process.
USP Further Strengthens Quality Standards for Heparin
USP optimizes identification tests and impurities procedures.
Key Considerations in Biosimilars Development
Understanding opportunities and challenges across all major phases of development.
Partnerships Remain Crucial to Future Development
Working together affords many unseen opportunities for pharmaceutical innovation.
Will the next US President support R&D?
Will the next US President support the backbone of our industry?
Considerations in Outsourced Vaccine Manufacturing
Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.
Moisture Matters in Lyophilized Drug Product
Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.
Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations
MIT survey results address product and site characteristics that statistically correlate with quality performance.
A 25-Year Retrospective on Cleanroom Management
Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management."
