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Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
Cleanroom and laboratory managers need to collaborate to set their employees up for success. They must also be willing to review their procedures even when it seems an employee is responsible for an error.
Features in this in-depth focus highlight the opportunities presented by targeted protein degradation therapeutics, as well as the breakthroughs in developing treatments for sickle cell disease.
Articles in this in-depth focus discuss how you can compare the accuracy of alternate and compendial micro methods and explore the use of RMM to enhance microbial control alongside compendial methods.
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need for data integrity in life sciences and how costs can be reduced but patient safety increased, and Charles River showcase their services and how they stand…
Here, Andrew Mitchell of IQVIA outlines the six stages of pharmacovigilance case automation, exploring how implementing intelligent automation such as AI and ML could benefit pharmaceutical companies.
In this issue experts explore the development of targeted protein degradation drugs, how potential legislative changes may impact the EU and selecting the right downstream process for bi-specific antibodies. Also featured in this journal, how RMM can enable efficient shutdown recovery, five critical areas for data integrity in life sciences…
The pandemic has been a game-changer for the pharmaceutical industry, sending the seemingly inexorable globalisation trends into reverse, with Big Pharma increasingly seeking more domestic supply chain options. Here, Karen Winterhalter of Onyx Health shares her expert insights on the impact of this emerging trend on the industry.
The EU’s identification of medicinal products (IDMP) standards implementation was all set to go ahead, when the EMA suddenly announced a change of plan. The DADI user interface will now enable structured data submissions for the EMA PMS, at least for the near future. Drawing on recent dialogue with the…
Here, Origin’s Rich Quelch explores the potential benefits of basing drug prescription on pharmacogenomic data and how transitioning to such a system could impact the UK’s National Health Service.
With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.
Small biopharma companies often need to partner with larger firms to achieve their goals, but such agreements can fail if preparations are poor. Here, Diane Seimetz and Jörg Schneider at Biopharma Excellence discuss how due diligence smooths the path to collaboration.
Work is underway to create a collaborative virtual research institute (VRI) to support the fundamental research and subsequent clinical translation of precision medicine in Abu Dhabi, as well as the United Arab Emirates more broadly. Here, European Pharmaceutical Review’s Hannah Balfour discusses the project with the Head of the new…
As the face of healthcare changes and the emphasis on more-targeted remedies and preventative care increases, pharma’s traditional role in healthcare must also evolve. Here, Vintura Consultancy’s Gérard Klop looks at how pharma might carve out a new role in a more value-based healthcare market.
