COVID-19 therapeutics to rely on large-scale biomanufacturing reactors, report says
A new report has found that if COVID-19 biologics are approved, it could apply pressure to the global biomanufacturing capacity.
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A new report has found that if COVID-19 biologics are approved, it could apply pressure to the global biomanufacturing capacity.
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
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…
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
Species-level microbial identification (ID) is a growing requirement under good manufacturing practice (GMP) to ensure patient safety.
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…
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.
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
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…
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.
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.
Hosted online from 11 – 12 November, Chemspec Digital 2020 provides an interactive networking event for the fine and speciality chemicals community. From all over the world, industry experts will have the opportunity to meet, conduct business, discover innovative substances and learn about the latest trends and developments.
Extractables studies for chromatography resins based on the adapted requirements of the USP support risk evaluation for chromatography steps.