How digitalisation can help pharma weather the COVID-19 storm
Andrew Dunbar outlines five digital technologies that can help pharma function to the best of its abilities over the course of the COVID-19 pandemic.
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Articles
Overview of workflows and data approaches in bioproduction – an industry perspective
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…
Exploring and deploying blockchain solutions in the life sciences and healthcare sectors
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…
How biotech is financing the lockdown dip
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…
Regenerative medicine: a manufacturing overview
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.…
Continuous manufacturing: ICH Q13
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.
The trials and tribulations of the medical devices and IVD regulations
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.
Improving quality in investigator‑led clinical trials
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.
NDMA: a recall trigger for the drug development industry
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.
Release of sterile medicinal products – looking at the focal points
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.
A novel cannabinoid formulation for glioblastoma treatment
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…
Developing a preventive vaccine regimen to tackle Ebola
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…
Expert view: Our air samplers are designed to perfectly match customer needs
A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
Expert view: Realising real-time TOC testing and Pharma 4.0 improvements in pharmaceutical grade water systems
This expert view from SUEZ discusses how total organic carbon (TOC) and conductivity monitoring are crucial aspects of purified water system quality and control.
Expert view: How robust is your fungal ID strategy?
This expert view from Charles River explores the different methods of fungal identification, allowing you to proactively address issues before they occur and provide information for successful remediation.
