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Issue 5 2020
In this article, William E Weiser discusses the advantages global pharmaceutical developers and manufacturers can gain from a laboratory information management system (LIMS) solution and highlights the key considerations to be made when integrating and standardising LIMS in their organisations.
On 6 August 2020, US President Donald Trump signed an executive order, dubbed ‘Buy American’, with the aim of increasing the production of essential medicines in the US for domestic use. Here, Victoria Rees discusses the order and what it means for drug manufacturers in the US and rest of…
As the race to develop a COVID-19 vaccine intensifies, nations are already ramping up production capacity on a scale never seen before – but what does this mean for manufacturers? Here, Rod Schregardus makes the case for advanced planning and scheduling techniques in new and existing facilities.
This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
Solid-state NMR spectroscopy is an effective technique for the analysis of both crystalline and amorphous pharmaceuticals, both in the drug substance and drug product. In this article, Eric Munson provides an overview of the technique and how it applies to pharmaceutical analysis.
Species-level microbial identification (ID) is a growing requirement under good manufacturing practice (GMP) to ensure patient safety.
A major challenge in achieving clinically relevant oral delivery of biologics is overcoming the multiple physiological barriers in the gastrointestinal tract. In this article Nikki Withers discusses these challenges with Shawn Davis, Head of Drug Delivery, BioPharmaceuticals Development, R&D at AstraZeneca, who shares some of the latest advances in drug…
The Vi-CELL BLU automates the widely accepted trypan blue dye exclusion method for cell viability that has historically been performed with a light microscope, pipette, and a hemacytometer.
Reducing unnecessary regulatory burden relating to excipients is important for any pharmaceutical manufacturer. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Kalyan Janjanam discuss a rational basis for controlling and specifying conflicting excipient attributes to avoid potentially tedious and complex regulatory processes.
There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
Expert view: The OXYCAPT™ multilayer plastic vial and syringe provides solutions for problems with current primary containers
There are several problems with existing primary containers; for example, glass suffers from breakage, delamination, etc., and plastic is an insufficient oxygen and ultraviolet (UV) barrier.
Digital transformation refers to the advent of various new and advancing technologies and their application in business to drive organisational efficiencies that would otherwise be impossible to achieve.