BioPharm International
February 02, 2018
Features
31
2
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
February 01, 2018
Cover Story
31
2
The critical quality attributes of biotherapeutics must be monitored to ensure product safety and efficacy.
February 01, 2018
Product Spotlight
31
2
The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP-regulated biotechnology and pharmaceutical operations.
February 01, 2018
Product Spotlight
31
2
LogTag has added two new devices to its temperature data logger series.
February 01, 2018
Features
31
2
This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
February 01, 2018
Features
31
2
Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.
February 01, 2018
Features
31
2
Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.
February 01, 2018
Features
31
2
As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
February 01, 2018
From the Editor
31
2
Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.
February 01, 2018
Features
31
2
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
February 01, 2018
Regulatory Beat
31
2
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
February 01, 2018
Ask the Expert
31
2
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.
February 01, 2018
Features
31
2
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
February 01, 2018
Features
31
2
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
February 01, 2018
Features
31
2
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.
February 01, 2018
Issue PDF
31
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Click the title above to open the BioPharm International February 2018 issue in an interactive PDF format.