ICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
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Articles
Why patient-centricity is essential to accelerate rare disease clinical research
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…
Effective data quality governance: challenging five common myths
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.
Insights into AstraZeneca’s MANDARA Phase III data
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.
Advancements and knowledge gaps in ICH Q2(R2)
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…
Advancing pharmaceutical technology: trends and innovations at ACHEMA 2024
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.
Dissolution of capsule with cross-linking
In this article, Jigar Shah, Senior Group Leader in Analytical Development at Baroque Pharmaceuticals, explores the intricacies of capsule dissolution testing.
Pioneering the next wave of LBP-based therapeutics
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.
What is the future of biologic medicines?
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.
From viral vectors to nucleic acids: biopharma’s evolving manufacturing landscape
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.
Application of NGS to enhance the molecular monitoring of CML patients
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.
Under the microscope: Using recombinant reagents for BET
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.
Bioprocessing / Bioproduction In-Depth Focus 2024
This in-depth focus features articles on bioreactor size, as well as bioprocess development and manufacturing of bioconjugated products.
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.
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.
