List view / Grid view

Issue 5 2018

 

Solid-state NMR spectroscopy: predicting stability in lyophilised biological products

2 November 2018 | By , ,

The emergence of biological drugs has led to an increase in lyophilised drug products in the market. Lyophilisation is a technique used to stabilise parenteral formulations in a solid form with the goal of producing chemically and physically stable, homogeneous, and high-quality lyo-products.

LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics

2 November 2018 | By

For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive…

Integrating data from QC and Production to enable fast, informed decisions

2 November 2018 | By

Managing the vast amounts of data involved in biopharmaceutical manufacturing and quality control workflows is often challenging due to the use of multiple stand-alone systems and devices that can act as information silos. However, with the need for tighter control of collected data, due to an increased regulatory focus, safeguarding…

Siemens: Spotlight on… Continuous Manufacturing

30 October 2018 | By

In this Spotlight on Continuous Manufacturing, Siemens offers pharmaceutical companies a unique portfolio of products (hardware and software), systems, solutions, and service – considering GxP* regulations – over the entire plant life cycle – as well as professional experience and interdisciplinary expertise...

Taking a collaborative approach to continuous pharmaceutical manufacturing

30 October 2018 | By

Offering increased yields, lower utility consumption and reduced waste, continuous manufacturing presents a paradigm shift in drug production and meets the pharmaceutical industry’s demands for faster product development, reduced costs, improved production economics and increased flexibility.