BioPharm International
September 01, 2015
Troubleshooting
28
9
Three case studies illustrate some analytical methods important for stability testing.
September 01, 2015
Cover Story
28
9
Focusing on niche and specialty service offerings gives contract biomanufacturing organizations an opportunity to differentiate in a crowded market.
September 01, 2015
Features
28
9
imagewerksBiophysical binding studies utilizing surface plasmon resonance, biolayer interferometry, isothermal titration calorimetry, or related techniques are ce
September 01, 2015
Features
28
9
Sorendls/Getty ImagesTo maintain a state of control and comply with regulatory authorities, many pharmaceutical, biotech, and medical-device companies have adopted continued pro
September 01, 2015
Regulatory Beat
28
9
Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
September 01, 2015
Perspectives on Outsourcing
28
9
Suppliers indicate prices for single-use equipment are likely to increase.
September 01, 2015
Product Spotlight
28
9
Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.
September 01, 2015
Features
28
9
The author discusses the current best practices in technical qualification of single-use systems.
September 01, 2015
Quality
28
9
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
September 01, 2015
Guest Editorial
28
9
Ensuring data integrity involves effort on an individual and global basis.
September 01, 2015
Downstream Processing
28
9
New single-use technologies and other filtration systems are beginning to address cost, throughput, and manufacturing footprint demands.
September 01, 2015
Issue PDF
28
9
Click the title above to open the BioPharm International September 2015 issue in an interactive PDF format.