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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.
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…
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…
When a client gets an opportunity to expand rapidly, it takes a global partner to pull it off without a hitch.
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…
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.
Rodney Steel, Chief Executive of the BCMPA – the Association for Contract Manufacturing, Packing, Fulfilment and Logistics – discusses the continued important role of outsourcing in the pharmaceutical industry and how contract manufacturers and packers have responded to some of the latest challenges.
The COVID-19 pandemic initiated a huge pharmaceutical effort to tackle the virus at the cause, resulting in a surge in innovation in vaccines and antiviral drugs. This is an R&D trend that is likely to continue in an attempt to protect ourselves from future outbreaks. In this article, IP Analyst…
Behind every technological advance there is often a leadership story just as interesting. In this article, Ben Woollard highlights key leadership behaviours that have been fundamental in biological innovation and suggests how businesses can implement these attributes to strive forward in a new era of biologics.
Numerous developments are ongoing to make advanced therapy medicinal products (ATMPs) more accessible, effective and less expensive. Here, legal experts Robert Stephen and Jane Hollywood from CMS discuss the increasing prevalence of these highly regulated therapies and the challenges faced by innovators in this space.
