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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.
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.
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.
The increasing use of subcutaneous administration stems from the significant advances in biological drug development, as well as the rising trend of self-administration.
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.
High-potency drugs present numerous opportunities for improved drug selectivity, efficacy and safety profiles.
The identification of N-nitrosodimethylamine (NDMA) in an active pharmaceutical ingredient (API) in 2018 not only led to regulatory warnings and product recalls, but wider recognition that pharmaceutical manufacturers should adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
Specialising in chromogenic and turbidimetric reagent technologies, ACC has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years.
