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Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists. NCIMB’s Identification…
Cyclodextrins are a frequently used excipient in the pharmaceutical industry, employed in multiple dosage forms and with multiple purposes simply because of their numerous positive properties, including being generally well tolerated and safe. In this short article, René Holm, Professor in pharmaceutical physical chemistry at the University of Southern Denmark,…
A new age of sustainability: discover how ACC’s PyroSmart NextGen® recombinant Cascade Reagent (rCR) enhances bacterial endotoxin testing (BET).
Here, Jason Fontenot, Chief Scientific Officer of Sangamo Therapeutics, discusses with EPR’s Hannah Balfour how the industry is developing chimeric antigen receptor (CAR) T regulatory cells (Tregs) as a potentially paradigm-shifting therapeutic option for conditions driven by the immune system, such as autoimmunity and transplant rejection.
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
Dave Elder explores US patent developments amid growing concerns that current approaches potentially delay generic drugs and biosimilars entering the market.
Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…
In EPR Issue 5, articles explore the role of whole genome sequencing in pharmaceutical microbiology, the formulation of oral taxanes and the potential for tackling immune-mediated disease with CAR T regulatory cells. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing and much…
Here, Origin’s Rich Quelch explores how pharma can adopt more sustainable packaging practices while balancing consumer safety.
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
Highlighting the findings of a recent supply chain report, EPR’s Hannah Balfour discusses measures pharmaceutical suppliers may adopt to establish demand- and crisis-resistant supply chains. Commenting on the findings, Ernst & Young Global Limited colleagues Famke Krumbmüller, Derron Stark and Olaf Zweig elaborate on the impact and lessons learned through…
Here IQVIA’s Dr Sophie Jouaville discusses the importance of risk minimisation measures, how their effectiveness can be assessed and why transparent reporting of these effectiveness studies is crucial.
In this article, Recipharm’s Joe Neale explores how learnings from the COVID-19 pandemic can be applied in the future and asks how nasal administration could help our fight against tomorrow’s outbreaks.
FUJIFILM Irvine Scientific excels in facilitating improved upstream cell culture and process development for the production of therapeutic proteins with custom media. Here, Burga Kalz-Fuller, Product Manager for Custom Media Services at FUJIFILM Irvine Scientific, answers frequently asked questions about personalised cell culture media solutions.
