A refreshed approach to fault tree analysis can be an incredibly helpful addition to your problem-solving armamentarium. Having the confidence to begin using it — or begin using it more often — is the first step toward getting more comfortable with it and mastering its effects and nuances.
With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.
Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.
The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health based exposure limits, for the implementation of science- and risk-based approaches to cleaning validation, and on the use of statistical techniques for measuring the risk in cleaning and assessing the effectiveness of cleaning processes.
The true effect of an intervention is often not seen until real-world usage takes place, but with such a delay between R&D and healthcare delivery, how can the industry close the gap? And what is needed to deliver more effective interventions that patients really want?
The new trade regime unleashed by President Trump has not only heightened trade tensions, it has the potential to affect patient access to affordable medicines. His administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.
While the designation for what constitutes a combination product is clearly defined by the FDA, industry continues to push the boundaries for disease treatment with new and innovative breakthrough drug therapies. As regulatory professionals, the challenge we face is to align these new therapies with application-filing strategies including investigational new drug applications, new drug applications, biologics license applications, and medical devices.
Most biopharmaceuticals are therapeutic proteins that are produced in living cells through recombinant engineering, and then purified from the cells or their culture media using sophisticated protein-purification techniques in a multistep downstream process. These processes — and the technologies that enable them — have experienced remarkable progress in the past 30 years, since the first biopharmaceuticals were approved for human use. This article will highlight some of today’s top trends in bioprocessing, as this exciting field continues to flourish.
During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?” The tone of the question was one of exasperation, as a number of those present at the meeting had recently felt the frustration and disruption of information security incidents.