QA/QC Microbiology/RMM In-Depth Focus 2022
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.
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Articles
Guide to Data Integrity
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…
Future of pharmacovigilance: the six stages of automation
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.
European Pharmaceutical Review Issue 3 2022
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…
Onshoring and global health – has the pandemic sent globalisation into reverse?
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.
What lies ahead for IDMP?
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…
Could personalised prescribing revolutionise the UK’s healthcare system?
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.
Early phase CGT trials: key design elements correlating to distinctive biological characteristics
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.
Preparation is key: the role of scientific due diligence in successful partnerships
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.
Establishing precision medicine in Abu Dhabi
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…
Pharma’s new healthcare role brings new opportunities
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.
The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
Advancing extractables and leachables testing
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
Can continuous manufacturing add shareholder value for pharmaceutical companies?
A recent empirical study of continuous manufacturing (CM) versus batch processing of US and non‑US pharmaceutical manufacturing facilities suggests that CM would be more economical than batch facilities, at least for the production of oral solid dosage products. This has significant consequences for policies and strategies to reduce supply chain…
Reducing downtime: acoustic emission testing of compressed air pressure vessels in pharmaceutical production
Leakage, cracking and corrosion in pressure vessels present a serious risk for operators of pharmaceutical production systems. Imminent damage must be reliably identified at an early stage to enable necessary steps to be promptly taken. Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, explains how TÜV SÜD…
