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There is an urgent need for novel treatment options for people living with rare diseases, but carrying out clinical research in this field is notoriously difficult. As Clinical Trials Day approaches, Cezary Statuch, Head of Medical Affairs International and Japan at Alexion Pharmaceuticals, highlights how adopting patient-centric approaches can help…
It is a well-established expectation that regulatory processes will become increasingly data focused, which places a new urgency on data quality governance in the pharmaceutical industry. In this Q&A Steve Gens and Preeya Beczek present a pragmatic view of what is involved.
In this Q&A, Dr Michael Wechsler, Professor of Medicine, Director of the National Jewish Health (NJH)/Cohen Family Asthma Institute, reveals details of the data from the MANDARA Phase III trial, showing remission is achievable in EGPA with Fasenra.
In this article, Amanda Guiraldelli Mahr, Joachim Ermer, Jaime Marach, Phil Borman and other members of USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. The authors also identify areas that would benefit from additional guidance and compare…
Taking place in Frankfurt, Germany on 10-14 June, ACHEMA 2024 is expected to bring together chemists, engineers and process technicians from across the pharmaceutical and other industries.
In this article, Jigar Shah, Senior Group Leader in Analytical Development at Baroque Pharmaceuticals, explores the intricacies of capsule dissolution testing.
Christopher Weidenmaier, PhD, Chief Scientific Officer, and Johannes B. Woehrstein, PhD, Chief Technology Officer at mbiomics share with EPR about the challenges and considerations of manufacturing microbiome-based therapeutics.
Sigma Mostafa, PhD, Chief Scientific Officer at KBI Biopharma, discusses the current trends in biologics and how technologies such as automation are advancing the field.
In this interview, Vikas Gupta, President of CDMO ReciBioPharm, outlines several key trends shaping the biopharma manufacturing landscape, including the rise of nucleic acid-based therapeutics, and the quest for continuous manufacturing.
Q&A with Dr Jin Li and Dr Chad Galderisi of ICON Specialty Laboratory Solutions on how Next Generation Sequencing can support more accurate monitoring of chronic myeloid leukemia patients.
Veronika Wills, Associate Director, Global Technical Services at Associates of Cape Cod, Inc (ACC), discusses in-depth, motivations and strategies surrounding the use of recombinant reagents for bacterial endotoxin testing.
This in-depth focus features articles on bioreactor size, as well as bioprocess development and manufacturing of bioconjugated products.
In this Guide to Testing articles explore limit of detection requirements for microbial testing of short-shelf-life products and sustainable endotoxin testing.
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
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.
