Guide to Testing 2024
In this Guide to Testing articles explore limit of detection requirements for microbial testing of short-shelf-life products and sustainable endotoxin testing.
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Articles
European Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
Supporting female leaders to advance cell and gene therapies
At the 2024 Advanced Therapies conference, panellists discussed the lack of women in leadership positions within the cell and gene therapy space and what could be contributing to this.
Safeguarding purity under pressure: detecting nitrosamine contamination
In this article, analytical chemist Venkata Ranga Rao Attaluri explores the ongoing challenges posed by nitrosamine contamination in pharmaceuticals, highlighting the importance of robust and sensitive analytical detection methods.
Unlocking innovative hydrogel treatments
Researchers from Queen's University Belfast, Garry Laverty, Sreekanth Pentlavalli and Yuming An, delve into the potential of an innovative ‘hydrogel’ version of the HIV drug zidovudine.
Monitoring pharmaceuticals in the environment
Andreas Häner, an environmental risk assessor at Roche in Group Safety, Security, Health & Environmental protection (SHE), speaks to EPR about how the pharmaceutical industry monitors manufacturing emissions that can impact local environments.
ebook: Twin-screw extrusion for pharmaceutical applications
This compendium explains how hot-melt extrusion can help overcome common challenges in pharmaceutical development, with guidance on all stages of the HME process from formulation characterization to process design/development, and downstream processing.
Is the pharmaceutical sector realising its potential for sustainable manufacturing?
Digitalisation could dramatically streamline the process of setting up and running pharmaceutical manufacturing processes, bringing sustainability and cost benefits, as Eric Flynn, Head of Pharmaceutical and Life Sciences at Siemens, explains.
Advancing microbiome innovation
In the fourth instalment of EPR's ‘Microbiome therapeutics: microscope to medicine’ series, Emilie Plantamura, Deputy Chief Medical Officer at MaaT Pharma, examines the promising potential of microbiome therapeutics beyond Clostridium difficile infection, particularly in the onco-haematological field.
Fractionation, purification and downstream processing: the path to commercialisation
With increasing progress in the life sciences, we are now able to treat diseases that were previously deemed incurable. This progress, however, comes with new challenges due to the growing complexity of chemical and biotherapeutic products. Developing and manufacturing compounds of interest in a pure and stable form quickly and efficiently…
Championing UK ATMP clinical trials
In this Q&A, Jacqueline Barry, Chief Clinical Officer for Cell and Gene Therapy Catapult, elucidates on how the Advanced Therapy Treatment Centre (ATTC) Network can strengthen UK ATMP clinical trials.
Endotoxin testing: the international regulatory landscape
In this extract from EPR’s Pharma Horizon’s report, Evelyn Der, Lindsey Silva and Carmen Marín Delgado de Robles from Roche Group discuss the regulatory guidelines for bacterial endotoxin testing and the move towards adoption of recombinant methods.
Coherent Raman scattering microscopy: a powerful tool for pharmaceutics
Coherent Raman scattering (CRS) microscopy is a powerful label-free technique that enables high-speed imaging of a sample’s chemical composition. Here, Raman experts Giulio Cerullo and Matteo Negro discuss how technological advances in the field can boost the broad applicability of CRS microscopy, as both an analytical tool for online monitoring…
Clinical trials for rare diseases
In this interview, Mindy Leffler, Managing Director of Qualitative Research and Psychometrics at Emmes Endpoint Solutions, discusses the nuances of designing clinical trials for rare diseases including specific challenges related to traditional endpoints.
Process analytics for the new era of continuous RNA manufacturing
In this article, Edita Botonjic-Sehic, Head of Process Analytics and Data Science at ReciBioPharm, examines the need for a digitally controlled continuous manufacturing process to correct the shortcomings of the current standard of batch processing. She highlights the critical role in-line process analytic technologies (PAT), automation and real-time data analytics…
