BioPharm International February 2018

February 2018 | Volume 31, Issue 2
BioPharm International February 2018 Issue
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By BioPharm International Editors
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Cover Story
The critical quality attributes of biotherapeutics must be monitored to ensure product safety and efficacy.
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.
Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.
As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
BioPharm International asked Andrew Bulpin, head of Process Solutions at MilliporeSigma, about the end-of-life options for disposable components of biopharmaceutical single-use systems.
Regulatory Beat
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
From the Editor
Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.
Ask the Expert
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
Product Spotlight
By BioPharm International Editors
The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP-regulated biotechnology and pharmaceutical operations.
By BioPharm International Editors
LogTag has added two new devices to its temperature data logger series.
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