Q&A with Sean McCarthy
Global Market Manager, Biologics, SCIEX
MAM is an acronym for Multiple Attribute Method. In short, MAM is a method which may be applied for characterization of a biotherapeutic to understand its sequence, identify liabilities, identify post-translational modifications, and develop an understanding of any critical quality attributes which may be present.
The vision of MAM in its first introduction several years ago was as a method that would be used throughout the development process and continue into the quality control environment. A key benefit of a MAM approach is that you are able to directly monitor product attributes. In this way, users may realize the benefit of replacing conventional assays with a single MAM approach.
Q. How has the role of mass spectrometry in biotherapeutic discovery and development changed in recent years?
A. Mass spectrometry (MS) has emerged as a de-facto technology for discovery and development of biotherapeutics. The ability of MS to provide highly accurate and detailed data on biopharmaceutical products, their targets, binding sites, modifications, impurities, and many other aspects is unparalleled by any other single techniques. Adding to this, instrument and software manufacturers have dramatically reduced the complexity of collecting and processing data. This has opened the use of MS to a wider audience than just a few short years ago. It is also clear that the role of MS in biotherapeutics will continue to grow as new molecular entities and their complexity grows.
Q. How can MAM be applied?
A. MAM can be applied in a wide range of ways. In reality, the concept of MAM has been around for quite a long time. Scientists are frequently asking many questions from their data. Using modern instrumentation and software tools, it is now becoming quite simple to define dedicated assays to interrogate data sets to ask and answer a wide range of questions simultaneously. We have seen the application in pre-development for hot spot/liability assessment, formulation, stability studies, process development, and others. In short, whenever there are multiple attributes of a molecule that may be perturbed the application of a MAM approach is appropriate.
Q. Where do you think MAM will go in the short and longer term in its application to biotherapeutic development?
A. In the short term, I see MAM gaining traction in those areas we have already discussed throughout biopharmaceutical development. I really see this approach enabling the QbD initiatives that regulatory agencies are seeking to see and that pharmaceutical companies are actively implementing. In some cases, MAM may begin to displace conventional assays, but in the short term will largely be complementary. In the long term, MAM certainly has the potential to replace many conventional assays and will end up in a quality control (QC) environment. While the potential exists for MAM to be a QC assay widespread adoption is likely to take some time.
Ready to Learn More About Mam and See MAM in Action?
Watch Sean’s on-demand webinar “Multi-Attribute Methodology (MAM) for Biotherapeutics Using LC-MS.” This presentation highlights how to implement a complete and easy-to-use MAM workflow for biotherapeutic PQA monitoring using accurate mass LC-MS. We will demonstrate how this new streamlined MAM workflow can be used to track known impurities and identify new impurities using a single software processing system that is as powerful as it is intuitive. Learn how to reduce your analytical testing burden by incorporating LC-MS into the development process.Watch the Webinar Now >