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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.
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.
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.
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…
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.
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 (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…
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.
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…
In this Q&A, EPR talks with health access specialist Dr Michal Davidescu about patient centricity, it’s impact on drug development considerations and why it’s essential to help treat our diverse and evolving global population.
This ebook explains how single-use filtration can support safer, more efficient biopharmaceutical production. Discover more on different filtration stages and unveil key characterisations, like pore size and membrane material, empowering tailored selection to specific biomolecules and processes.
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
On World Kidney Day 2024, Dr Marshall Fordyce, CEO of Vera Therapeutics explores the challenges of treating kidney disease and shares why the company’s lead candidate could become the first self-administered B-cell modulation therapy.
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
