BioPharm International, March 2014 - BioPharm International

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BioPharm International, March 2014
Cover Story
Advances in Linker Technology
By Cynthia Challener, PhD
The targeted delivery of cytotoxic drugs using antibody drug conjugates would not be possible without effective linkers to connect and then release the key chemical and biological materials.
Features
Control Strategies for Synthetic Therapeutic Peptide APIs— Part I: Analytical Consideration
By Aleksander Swietlow , Harold Rode , Anita Szajek , Michael Verlander , Ivo Eggen , Brian Gregg
USP evaluates quality attributes for synthetic peptides.
Predicting Lyophilization Performance
By Cynthia Challener, PhD
Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.
Special Section
An Environmental Lifecycle Assessment of Single-Use and Conventional Process Technology: Comprehensive Environmental Impacts
By William Flanagan , Matthew Pietrzykowski , Vincent Pizzi , Andrew Brown , Andrew Sinclair , Miriam Monge
An environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.
Single-Use Technology for Syringe Filling
By Andrea Detroy , Christian Matz , Mark Leykin , Ernest Jenness , Ross W. Acucena
A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.
Peer-Reviewed Research
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
By Mark Mitchell
This series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
Perspectives on Outsourcing
Under New Ownership
By Jim Miller
Changes in company ownership shake up the CMO industry.
Analytical Best Practices
Design of Experiments for Analytical Method Development and Validation
By Thomas A. Little, PhD
Design of experiment is a powerful development tool for method characterization and method validation.
Global News
Regulators Get Tough on Corruption in China
By Jane Wan
China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.
Regulatory Beat
Manufacturers Struggle with Breakthrough Drug Development
By Jill Wechsler
Accelerated testing and production create challenges in documenting product quality.
European Union Packaging Safety Features Come into Effect
By Sean Milmo
Manufacturers are taking measures to comply with new package safety rules.
Guest Editorial
INTERPHEX 2014: New Partners, New Programs
By RJ Palermo
Conference programming from PDA and BioPharm International expand educational opportunities at Interphex 2014.
Products
ALpHA G Capsule Filter for Single-Use Systems
By Melanie Sena
ALpHA G Capsule Filter for Single-Use Systems
Stain-Free Chromatography Workflow
By Melanie Sena
Stain-Free Chromatography Workflow
UPLC System for Nano- to Microscale Separations
By Melanie Sena
UPLC System for Nano- to Microscale Separations

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