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David Elder

 

QA/QC In-Depth Focus

In this In-Depth Focus: Quality control of freeze-dried oral formulations;…

25 August 2017 | By

In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...

Separations & Purifications In-Depth Focus 2017

In this Separations & Purifications In-Depth Focus: Experts from Leo…

3 July 2017 | By

In this Separations & Purifications In-Depth Focus: Experts from Leo Pharma explain how they use an MHC 2D-LC system in their analytical troubleshooting laboratory and how it can be applied to solve key tasks in the lab. Plus, Dave Elder explains how guidance for mutagenic impurities has necessitated control of…

NIR In-Depth Focus 2017

In this NIR In-Depth Focus: Monitoring and controlling drug products…

22 February 2017 | By

In this NIR In-Depth Focus: Monitoring and controlling drug products and manufacturing processes with NIRS; Development of a NIRS method for quantification of a minor polymorphic form; and an Expert View with Metrohm Process Analytics...

Biosimilars – future prospects

Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs),…

30 June 2016 | By

Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs), are playing an increasingly important role in global healthcare. It was recently reported that mAB therapeutics sell for over $50 billion globally. However, one of the major downsides of biological therapeutics is their significantly greater costs compared with small molecule…

Foreword: The evolving pharmacopoeia

Globalisation has facilitated greater international harmonisation and standardisation of quality…

29 February 2016 | By

Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias1. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on…

Dissolution testing in the modern world

Historically, dissolution testing has been used primarily as a quality…

29 February 2016 | By ,

Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…

PAT In-Depth Focus 2015

Featuring an overview of process analytical control; Beyond API monitoring:…

6 January 2016 | By

Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable...

Use of the ‘purge tool’ in assessing mutagenic impurities

The International Conference on Harmonization M7 text provides guidance on…

6 January 2016 | By Dave Elder, GlaxoSmithKline and JPAG

The International Conference on Harmonization M7 text provides guidance on establishing acceptable levels of mutagenic impurities (MIs) . It also outlines the safety and quality risk management processes that manufacturers need to undertake to control MIs that may potentially affect the drug substance or drug product. Over the past decade,…

Foreword: Importation testing: an unnecessary burden on industry?

One of the principle objectives of the Internal Conference on…

22 October 2015 | By ,

One of the principle objectives of the Internal Conference on Harmonisation (ICH) initiatives was to introduce harmonised approaches, prevent duplication and eliminate wasteful and unnecessary testing. Although good progress was made initially, there was evidence that certain countries, regions and trans-national organisations were unhappy with some of the proposed harmonised…

Informatics In-Depth Focus 2015

In this Informatics In-Depth Focus: Informatics in 2025, Methods for…

3 September 2015 | By

In this Informatics In-Depth Focus: Informatics in 2025, Methods for the detection of drug-drug interactions in text & Computational approaches to mutagenicity assessments of impurities: in silico methods...