The nitrosamine impurity crisis continues to be on the mind of every stakeholder involved in the development and manufacturing of affected drug products. In our interactions with key opinion leaders and those in the lab having to develop and validate nitrosamine testing methods, we’ve come across a few common questions that we want to address here
The recent nitrosamine impurity crisis has brought into question the quality of many APIs (Active Pharmaceutical Ingredients) produced and sourced for a number of popular drugs, resulting in product recalls, lost profits, and regulatory actions.… Read more >
In our most recent Method Lifecycle Management webinar held Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach, Joseph A. Turpin, Director of Chromatography Products and Services at S-Matrix Corporation and Tran Pham, Business Development Manager at Waters Corporation, presented an overview of Quality by Design approaches to analytical method development (AQbD), the regulatory views on this approach, examples of design of experiments in AQbD, and case studies demonstrating software assisted AQbD method development.
In January of 2018, Waters kicked off its global Bioharmonization campaign with a blog post and video release, laying out a vision for how the Biopharmaceutical industry can achieve accelerated development and improved quality while… Read more >
For starters no one wants a disastrous vacation, the same goes for a bioanalysis assay! What makes for a great vacation? A booking agent who understands you, on time transit, a room with a view… Read more >
What does “intelligence” mean in the context of biopharma analysis? Given the complex setting, much of the answer comes down to the task a user needs to complete, along with the question of who exactly… Read more >
There’s no question that we’ve entered the age of smart technology. Your phone, your home, your refrigerator, even your light bulbs are all getting smarter. Such technologies do more and more to run themselves, removing… Read more >
In late January, I traveled to WCBP (Well Characterized Biological Products), an industry conference that is hosted every year by the CASSS organization. It serves as a forum that brings together biopharmaceutical industry professionals and… Read more >
Waters recently surveyed 100 method developers from innovator and generic pharmaceutical companies to better understand their existing challenges and views on Method Lifecycle Management (MLCM). We’ll share with you the top questions and findings from our survey results.
Its great promise for routine monitoring of biologic drugs begs the question: Just when will LC-MS analysis become a true bedrock analytical tool for scientists and technicians throughout biopharma?