List view / Grid view
The landscape of biopharmaceutical manufacturing is changing, with complex molecules such as bi-specific antibodies (bsAbs) becoming increasingly prevalent. bsAbs are a large, structurally diverse family of molecules designed to recognise two targets and globally there are over 230 in development as promising therapies for cancer and other diseases. While they…
With almost every aspect of pharmaceutical regulation currently under review across Europe and the proposal for changes expected in December 2022, in this article, Maarten Meulenbelt, Partner at Sidley Austin LLP, discusses with European Pharmaceutical Review some of the more controversial amendments under consideration and emphasises why industry participation is…
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
With two knighthoods in the last month, here EPR discusses five developments in the drug development community’s C-suite.
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…
