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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…

NIR inspection of each tablet that exits a tablet press

31 October 2018 | By , , , ,

In the pharmaceutical industry, waste represents at least 25% of the cost of quality. In 2004, the Food and Drug Administration (FDA) published a guide to promote the implementation of Process Analytical Technologies (PATs) in the pharmaceutical industry. This would allow better quality control (QC) and monitoring directly on the…

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.

Expert view: The QC micro labs have grown to tackle new challenges

29 October 2018 | By Charles River

Timelines, budgets and regulatory constraints have grown alongside that of the Quality Control (QC) lab’s position in drug development. The main goal of the lab and more widely of the manufacturing industry is to increase safety for the end user and guarantee patients’ health...