BioPharm International-02-01-2018

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

The critical quality attributes of biotherapeutics must be monitored to ensure product safety and efficacy.

Product Spotlight

February 01, 2018

The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP-regulated biotechnology and pharmaceutical operations.

Product Spotlight

February 01, 2018

LogTag has added two new devices to its temperature data logger series.

Features

February 01, 2018

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.

From the Editor

February 01, 2018

Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.

Features

February 01, 2018

Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.

Regulatory Beat

February 01, 2018

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

Ask the Expert

February 01, 2018

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.

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.

Features

February 01, 2018

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.

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