List view / Grid view
Relying on manual processes for managing serialised medicines at an individual pack level is a labour intensive and time-consuming process that can disrupt normal operations. In this article, Sébastien Sliski outlines how digitally enabled inventory processes, such as aggregation and consolidation, can help pharmaceutical wholesalers and hospital pharmacies meet their…
The rapid evolution of the COVID-19 situation has created significant barriers to normal operations, from locking down borders to the imposition of restrictions on trade and export – not to mention a surge in demand for many common medicines. Each of these events in isolation can affect production and supply,…
Downstream processing is an integral part of the production process of biopharmaceuticals and contributes quite significantly to the overall productivity and product quality, as well as to processing costs. Melanie Diefenbacher of Genedata provides a comprehensive overview of downstream processes, highlighting several challenges and the importance of investing into automation…
Blockchain is perhaps best known as the technology on which Bitcoin and other cryptocurrencies are built. Notwithstanding that adoption in the life sciences and healthcare sectors is still in its relative infancy, companies and other organisations in these sectors are increasingly exploring and deploying blockchain solutions. Here, legal experts James…
The COVID-19 pandemic has had huge knock-on effects on economies around the world. In this article, legal experts from Taylor Wessing explore how the novel coronavirus has hit the life sciences and biotech investment sector and how they see investors behaving as the lockdown and pandemic eases and develops over…
The field of regenerative medicine – an area promising a revolution in 21st century healthcare – has been enabled by rapid scientific advancements in recent years. There is a growing need for a new generation of therapeutic products, made more severe by the global shortages of organs available for transplantations.…
Although steps have been taken to enable the implementation of continuous manufacturing in industry, a lack of global harmonisation in regulations has slowed the adoption of this promising emerging technology. Dave Elder discusses how ICH Q13 seeks to provide a harmonised approach to support this important initiative.
This article explores the reasons behind the introduction of the EU Medical Device (MDR) and In Vitro Diagnostic Devices (IVDR) regulations, the problems that beset them and how COVID-19 finally persuaded the European Commission that a further year’s preparation time for full application of the regulations was necessary.
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.
Earlier this year, MGC Pharmaceuticals, in collaboration with the Slovenian National Institute of Biology (NIB) and the Neurosurgery Department at the University Medical Centre in Ljubljana, Slovenia, announced successful research results for their novel cannabinoid formulation, which has been developed for the treatment of glioblastoma. This article highlights the key…
Earlier this year, Johnson & Johnson announced the first major regulatory approval of a vaccine developed by Janssen for the prevention of Ebola. Nikki Withers spoke with the Global Head of Vaccines, Johan Van Hoof, to discover what technologies were used and how they are now being leveraged to develop…
This application note explores how BD is dedicated to deliver best-in-class product performance and services by applying the latest advances in drug delivery technology.
Beckman Coulter Life Sciences has introduced the MET ONE 3400+ portable air particle counter to help GMP cleanroom users simplify their routine environmental monitoring and improve data integrity.
A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
