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BioPharm International-03-01-2015
BioPharm International
USP Publishes Monoclonal Antibody Guidelines
March 02, 2015
Inside Standards
28
3
A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
Maintaining the Stability of Biologics
March 01, 2015
Features
28
3
It is important to understand degradation and processing to maintain product stability in biologics.
Springing Forward
March 01, 2015
From the Editor
28
3
Sessions address cell therapies, serialization, contract services, and more.
Reinventing the Cold Chain in a High-Stakes Market
March 01, 2015
Features
28
3
Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.
A Robust CAPA System for a Global Supply Chain
March 01, 2015
Features
28
3
Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
CMOs Plan for Capacity Expansions
March 01, 2015
Perspectives on Outsourcing
28
3
Is there enough talent to go around?
Vaccine Development and Production Challenges Manufacturers
March 01, 2015
Regulatory Beat
28
3
Scientists and industry experts seek effective preventive therapies to combat global disease.
Detecting Protein Aggregates and Evaluating their Immunogenicity
March 01, 2015
Features
28
3
The thorough analysis of a therapeutic protein product’s propensity to aggregate may be a necessary step in the prevention of a cell-mediated immune response.
Re-use of Protein A Resin: Fouling and Economics
March 01, 2015
Features
28
3
Large-scale implementation of Protein A chromatography offers several challenges.
SEC in the Modern Downstream Purification Process
March 01, 2015
Features
28
3
Recent technological advances in the way biologic therapeutics are purified may bring size-exclusion chromatography back into the modern purification process.
Polyethylene Biocontainer Increases Customizability
March 01, 2015
Product Spotlight
28
3
Meissner’s TepoFlex is a polyethylene biocontainer designed for secure handling and it is part of the One-Touch single-use systems portfolio.
3M Purification’s Emphaze AEX Hybrid Purifier
March 01, 2015
Product Spotlight
28
3
The all-synthetic clarifying product line contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.
Tools of the Trade for Preventing Drug Shortages
March 01, 2015
Inside Standards
28
3
A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.
BioPharm International, March 2015 Issue (PDF)
March 01, 2015
Issue PDF
28
3
Click the title above to open the BioPharm International March 2015 issue in an interactive PDF format.
The Global Biomanufacturing Outsourcing Market
February 20, 2015
Global News
28
3
The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.