Stability Testing in Biopharma
Three case studies illustrate some analytical methods important for stability testing.
Contract Biomanufacturing Firms Become More Specialized
Focusing on niche and specialty service offerings gives contract biomanufacturing organizations an opportunity to differentiate in a crowded market.
Enhancing Protein Binding Studies with a Light-Scattering Toolkit
imagewerksBiophysical binding studies utilizing surface plasmon resonance, biolayer interferometry, isothermal titration calorimetry, or related techniques are ce
Utilizing Run Rules for Effective Monitoring in Manufacturing
Sorendls/Getty ImagesTo maintain a state of control and comply with regulatory authorities, many pharmaceutical, biotech, and medical-device companies have adopted continued pro
Manufacturers Face Key Policy and Regulatory Challenges
Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
CMOs Concerned With Cost of Single-Use Equipment
Suppliers indicate prices for single-use equipment are likely to increase.
Biocontainer Assemblies Provide Repeatable Performance
Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
Data Integrity: Getting Back to Basics
Ensuring data integrity involves effort on an individual and global basis.
High Titers and Perfusion Processes Challenge Cell Harvesting Systems
New single-use technologies and other filtration systems are beginning to address cost, throughput, and manufacturing footprint demands.
BioPharm International, September 2015 Issue (PDF)
Click the title above to open the BioPharm International September 2015 issue in an interactive PDF format.
