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BioPharm International-03-01-2014
BioPharm International
Manufacturers Struggle with Breakthrough Drug Development
March 01, 2014
Regulatory Beat
27
3
Accelerated testing and production create challenges in documenting product quality.
Regulators Get Tough on Corruption in China
March 01, 2014
Global News
27
3
China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.
Control Strategies for Synthetic Therapeutic Peptide APIs— Part I: Analytical Consideration
March 01, 2014
Features
27
3
USP evaluates quality attributes for synthetic peptides.
UPLC System for Nano- to Microscale Separations
March 01, 2014
Products
27
3
UPLC System for Nano- to Microscale Separations
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
March 01, 2014
Peer-Reviewed Research
27
3
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.
Predicting Lyophilization Performance
March 01, 2014
Features
27
3
Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.
ALpHA G Capsule Filter for Single-Use Systems
March 01, 2014
Products
27
3
ALpHA G Capsule Filter for Single-Use Systems
Design of Experiments for Analytical Method Development and Validation
March 01, 2014
Analytical Best Practices
27
3
Design of experiment is a powerful development tool for method characterization and method validation.
European Union Packaging Safety Features Come into Effect
March 01, 2014
Regulatory Beat
27
3
Manufacturers are taking measures to comply with new package safety rules.
Advances in Linker Technology: Improving the Safety and Efficacy of Antibody Drug Conjugates
March 01, 2014
Cover Story
27
3
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.
Under New Ownership
March 01, 2014
Perspectives on Outsourcing
27
3
Changes in company ownership shake up the CMO industry.
INTERPHEX 2014: New Partners, New Programs
March 01, 2014
Guest Editorial
27
3
Conference programming from PDA and BioPharm International expand educational opportunities at Interphex 2014.
An Environmental Lifecycle Assessment of Single-Use and Conventional Process Technology: Comprehensive Environmental Impacts
March 01, 2014
Special Section
27
3
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
March 01, 2014
Special Section
27
3
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.
BioPharm International, March 2014 Issue (PDF)
March 01, 2014
27
3
Click the title above to open the BioPharm International March 2014 issue in an interactive PDF format.