Improving fungal ID options
This article explores a novel method for fungal identification. A case study is presented which showed this method was superior to the reference method with increased identification rates and lower misidentification.
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Articles
How an integrated LIMS platform can transform drug development and manufacturing workflows
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.
How will Trump’s ‘Buy American’ executive order impact pharmaceutical supply chains?
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…
Stepping up metformin production: a case study
This article describes how researchers stepped up metformin tablet production from a pilot scale coater to three industrial scale equipment lines.
Scaling up production capacity when the world is waiting
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.
Should life sciences businesses require employees to use the NHS COVID-19 App when at work?
The NHS COVID-19 App was introduced in the UK on 24 September. Many welcome its arrival as another step to contain the spread of COVID-19, while others are concerned about using the app for data and privacy reasons. In this article Helen Farr, a partner at Taylor Wessing, explores the…
Primary validation of the growth direct bioburden system and media
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 of drug substances and drug products
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.
Expert view: Mitigating risk with modern microbial identifications
Species-level microbial identification (ID) is a growing requirement under good manufacturing practice (GMP) to ensure patient safety.
Alternative routes of administration – a focus on oral biologics
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…
How a global network provides a genuine advantage
When a client gets an opportunity to expand rapidly, it takes a global partner to pull it off without a hitch.
Science and risk-based specification setting for excipients
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.
Approval of regulatory starting materials
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.
Expert view: Enabling Pharma 4.0 through digital transformation
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.
