USP Publishes Monoclonal Antibody Guidelines
A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
Maintaining the Stability of Biologics
It is important to understand degradation and processing to maintain product stability in biologics.
Springing Forward
Sessions address cell therapies, serialization, contract services, and more.
Reinventing the Cold Chain in a High-Stakes Market
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
Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
CMOs Plan for Capacity Expansions
Is there enough talent to go around?
Vaccine Development and Production Challenges Manufacturers
Scientists and industry experts seek effective preventive therapies to combat global disease.
Detecting Protein Aggregates and Evaluating their Immunogenicity
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
Large-scale implementation of Protein A chromatography offers several challenges.
SEC in the Modern Downstream Purification Process
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
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
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
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)
Click the title above to open the BioPharm International March 2015 issue in an interactive PDF format.
The Global Biomanufacturing Outsourcing Market
The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.
