BioPharm International, April 2014 - BioPharm International

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BioPharm International, April 2014
Cover Story
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
By Cynthia Challener, PhD
The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.
Features
Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations
By Ivo Eggen , Brian Gregg , Harold Rode , Aleksander Swietlow , Michael Verlander , Anita Szajek
USP evaluates raw materials used in the chemical synthesis of peptides.
Manufacturing Best Practices
Raw Material Variability
By Simon Chalk
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
Peer-Reviewed Research
Implications of Trace Levels of Redox-Active Metals in Drug-Product Formulation
By Vikram Sadineni , Sangita Chandrasekharan , Munir N. Nassar
The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.
European Beat
Quality by Design Bridging the Gap between Concept and Implementation
By Sean Milmo
As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.
Regulatory Beat
FDA and Manufacturers Seek a More Secure Drug Supply Chain
By Jill Wechsler
New identifiers and tracking requirements aim to block illegitimate products.
Perspectives on Outsourcing
Biopharma Outsourcing Activities Update
By Eric Langer
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Burrill on Biotech
Biotech IPOs on a Hot Streak
By G. Steven Burrill
Life-sciences companies continue upward momentum in 2014.
Global News
Global Instability Affects the Pharma Market in Brazil
By Hellen Berger
How badly is Brazil's pharmaceutical market suffering from the global instability of emerging markets?
From the Editor
Publishing Beyond the Printed Page
By Rita Peters
More media options open publishing opportunities for bioprocessing experts and authors.
Products
High-Performance Separation-Electrospray Ionization System
By Melanie Sena
High-Performance Separation-Electrospray Ionization System
Aggregation System Improves Analysis of Sub-Visible Particles
By Melanie Sena
Aggregation System Improves Analysis of Sub-Visible Particles
UPLC Separation Intergrates into Mass Spectrometers
By Melanie Sena
UPLC Separation Intergrates into Mass Spectrometers
Mass Spectrometer Enhances Performance in Protein Analysis
By Melanie Sena
Mass Spectrometer Enhances Performance in Protein Analysis
Line of Environmental Measurement Products
By Melanie Sena
Line of Environmental Measurement Products
Liquid Chromatography Column Separates Glycans
By Melanie Sena
Liquid Chromatography Column Separates Glycans

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