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.
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Articles
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.
Outsourcing firms demonstrate resilience in the face of uncertainty
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.
Using patent data to get ahead of the next pandemic
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…
Biologics: a leadership journey
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.
A crucial turning point for increasing patient access to ATMPs
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.
What the world can learn from the UK’s pharmaceutical industry
Through the recent coronavirus crisis, the UK’s pharmaceutical sector has performed strongly and delivered innovation at a time when it was most needed. In this article, Dr Cheryl Teoh discusses how the industry has been set up for success.
Availability of critical medicines during pandemics
The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
Expert view: High viscosity, high volume biologics call for new delivery device designs
The increasing use of subcutaneous administration stems from the significant advances in biological drug development, as well as the rising trend of self-administration.
Expert view: Maximising treatment efficacy
As a world-leading drug device combination solutions specialist, our purpose of putting patients first enables us to design and manufacture devices that maximise treatment efficacy.
