Validation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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Articles
Developing a new treatment paradigm for IgAN
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.
Live biotherapeutic products: bridging innovations and challenges in manufacturing
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.
Data integrity considerations in pharma and life sciences
In this Q&A, data expert Joseph S Boakai addresses decisive factors impacting data integrity in the pharma and life sciences industries.
Developing new treatment regimens for HIV
Here, Sherene Min, Vice President and Head of Global Clinical Development at ViiV Healthcare, explains how the HIV treatment landscape is changing, with moves towards long acting and self‑administered treatments.
The future of targeted alpha therapy development and manufacture
Following the first industrial-scale facility for targeted alpha therapy (TAT) production in Europe beginning construction, in this exclusive Q&A, Julien Dodet, CEO of Orano Med, elaborates on the key trends in radioligand therapeutics and why TATs hold significant advantages as cancer treatments.
Under the microscope: Time to consider perfusion?
Erik Vaessen, Chief Business Officer at FUJIFILM Irvine Scientific, reveals the benefits of continuous culture processing and considerations for optimal bioproduction.
Analytica 2024 in overview
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum…
Delivery systems for biologics
Designing systems for delivery of biologics is often a significant challenge during clinical development. Here, Dave Li, Edyta Działo and Anna Baran of KCR Consulting highlight the need for balancing safety, effectiveness, cost and reducing patient discomfort.
Forward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends
Some of the most sought-after human experiences are health and happiness. Although pharmaceutical companies cannot determine personal happiness, they are working to improve personal health outcomes that can tip the scale. The demand for personalised medicines, cell and gene therapies, hyperresponsive and patient-centric healthcare, real-world data fuelled by artificial intelligence…
European Pharmaceutical Review Issue 1 2024
EPR Issue 1 includes articles on separation & purification, process analytical technology and drug delivery. Register your details now to download this exclusive content.
Rare disease spotlight: first EU-approved treatment for Friedreich’s ataxia
In this exclusive article, Biogen’s Vice President and Head of the Neuromuscular Development Unit, Dr Toby Ferguson, discusses the current rare disease landscape and recent developments in treating Friedreich’s ataxia (FA).
Making ATMPs a reality for rare disease patients
Advanced therapy medicinal products (ATMPs) will be among the first to undergo joint clinical assessments at EU level in 2025 and these will form the basis for national value assessments and pricing negotiations. Here, Paolo Morgese from the Alliance for Regenerative Medicine discusses how methodologies for joint clinical assessments (JCAs)…
Driving the UK’s “innovation engine” for novel AMR therapeutics
Despite the UK having “a very healthy” therapeutic pipeline, more needs to be done in the fight against antimicrobial resistance (AMR), NovaBiotics’ CEO asserts.
