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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
September 01, 2015
Three case studies illustrate some analytical methods important for stability testing.
Focusing on niche and specialty service offerings gives contract biomanufacturing organizations an opportunity to differentiate in a crowded market.
imagewerksBiophysical binding studies utilizing surface plasmon resonance, biolayer interferometry, isothermal titration calorimetry, or related techniques are ce
Sorendls/Getty ImagesTo maintain a state of control and comply with regulatory authorities, many pharmaceutical, biotech, and medical-device companies have adopted continued pro
Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
Perspectives on Outsourcing
Suppliers indicate prices for single-use equipment are likely to increase.
Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.
The author discusses the current best practices in technical qualification of single-use systems.
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
Ensuring data integrity involves effort on an individual and global basis.
New single-use technologies and other filtration systems are beginning to address cost, throughput, and manufacturing footprint demands.
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