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Sample handling and preparation can have a substantial effect on an analytical method’s variability and data quality. It is important to consider and address the risks associated with sample preparation as part of the method development process. This requires carefully designed and executed experiments and clear documentation in the method to give the analyst an…
Scientists that have worked with peptides understand that peptide quantification can be challenging. One of the keys to successful peptide analysis is thorough and selective sample preparation. Sample preparation improves various aspects of chromatography and mass spectrometry analyses by utilizing solid phase extraction (SPE) to chemically separate different analytes and aid in removing the interfering…
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. Within a drug manufacturing process that is increasingly outsourced and globalized, companies manufacturing the API or in-sourcing the API or…
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.
The characterization of peptides and proteins can be challenging due to issues such as adsorption, varying hydrophobicities, and specificity to name just a few. When analyzing peptides by Liquid Chromatography (LC) and Mass Spectrometry (MS), it’s beneficial to introduce mobile phase additives in order to facilitate ionization and enhance the analyte signal. Additionally, these additives…
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 enhancing productivity and lowering production costs. Central to this vision are “fit-for-purpose” analytical tools working together within a single compliance-ready…
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 a stones throw from the beach, friendly staff and great cuisine? Knowing that you are in safe hands and leaving…
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 that user is. In developing our BioAccord System, we wanted to expand the possibilities of high-resolution LC-MS analysis from characterization…
Confronting the challenge of sensitivity and sample loss As a relative newcomer to peptide and protein quantification coming from the small molecule world, I have learned that I need to think differently, and more creatively, to meet the challenges of these molecules. As scientists with assay sensitivity goals, we sometimes have to take extra steps…
My sample stayed in the solution…or did it? Samples are precious. Well-prepared samples are the starting point of all successful experiments. That’s why we spend time and effort on sample preparation; so that the resulting samples are ready for downstream LC analyses. When we think of good sample prep and handling, we emphasize the sample…
As a chromatography scientist at Waters, I often get the opportunity to travel to different laboratories around the world and to meet with various types of researchers. This allows me to stay up to date on the newest scientific trends and topics, particularly in the fast growing world of biopharmaceutical analysis. In June of this…
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 steps and complexity, while making user interactions easier and more intuitive. They continually improve, and as they do they become…