BioPharm International, October 2012 - BioPharm International

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BioPharm International, October 2012
Features
Considerations in Outsourced Vaccine Manufacturing
By Amy Ritter, PhD
Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.
Considerations in Vaccine Packaging and Delivery Systems
By Amy Ritter, PhD
Glenn Thorpe of West Pharmaceutical Services gives an update on packaging and delivery methods for vaccines.
Vaccine Packaging at the Clinical Interface of Vaccine, Healthcare Worker, and Patient
By Brian Lynch , Philip Song
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.
A Manufacturing-Capacity Sharing Model
By Patricia Van Arnum
The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."
Key Considerations in Biosimilars Development
By Raymond Donninger , Joe Bower , Raymond Kaiser , Sian Estdale , John Carlsen
Understanding opportunities and challenges across all major phases of development.
Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations
By Reuben D. Domike , Jeffrey T. Macher , Paul W. Barone , Stacy L. Springs , Anthony J. Sinskey , Scott Stern
MIT survey results address product and site characteristics that statistically correlate with quality performance.
Bringing Innovation to Neglected Disease R&D
By BIO Ventures for Global Health , Biotechnology Industry Organization
A new report highlights the industry's contributions to neglected diseases and calls for further collaboration.
A 25-Year Retrospective on Cleanroom Management
By Anne Marie Dixon
Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management."
From the Editor
Will the next US President support R&D?
By Angie Drakulich
Will the next US President support the backbone of our industry?
Guest Editorial
Partnerships Remain Crucial to Future Development
By David Mitchell
Working together affords many unseen opportunities for pharmaceutical innovation.
Global Reports
Discovery Pipeline: Nanoparticles for Targeted Delivery
By Amy Ritter, PhD
Recently published research demonstrates how nanoparticles can be used to overcome hurdles in localized drug delivery.
Report from India
By Jane Wan
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.
Regulatory Beat
New Era for Generic Drugs
By Jill Wechsler
User fees aim to speed approvals and support inspections.
Perspectives on Outsourcing
Sizing the Market for Contract Manufacturing
By Jim Miller
Measuring the size of the market for contract manufacturing services requires a careful hand.
Burrill on Biotech
Recent Therapeutics IPOs Outshine Market, but Performance Mixed for Broader Life-Sciences Issues
By G. Steven Burrill
A handful of therapeutics have performed extremely well in 2012, but as a whole, life-sciences are still down from 2010.
Inside USP
USP Further Strengthens Quality Standards for Heparin
By Anita Y. Szajek
USP optimizes identification tests and impurities procedures.
Bioanalytical Best Practices
Meeting Challenges for Analysis of Antibody-Drug Conjugates
By Yi Qun Xiao , Andreea Halford , Roger N. Hayes
The complex structure of ADCs necessitates different analytical strategies than those for either small molecules or unconjugated monoclonal antibodies.
Analytical Best Practices
Moisture Matters in Lyophilized Drug Product
By Leu-Fen H. Lin, PhD , Richard Bunnell, PhD
Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.
Boot Camp Technical Guide
Downstream Processing: A Primer
NIBRT's Ian Nelligan on what to expect when starting a downstream process.
Final Word
FDA and the Importance of Confidentiality
By David L. Rosen
Do you have to worry about FDA releasing confidential data? Apparently so.

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