Is The Answer To Ever Increasing Biotherapeutic Complexity Simple?
In recent years biopharmaceuticals (protein-based pharmaceuticals, manufactured by biotechnological methods) have become successful both medicinally and commercially. Biotherapeutics are inherently heterogeneous and in their pursuit of becoming ever more specific, these drugs are becoming more and more complex.
During development and production of these products, it is essential to detect, characterize, and quantify impurities as well as structural variants and modifications, and to monitor product stability. This is key to demonstrating their safety and efficacy, and is required by the U.S. FDA and other regulatory agencies.
With the plethora of analytical approaches, together with ever increasing molecule complexity, it’s easy to see the challenges - but could the trick actually be to keep things simple!?
Simple Charge Variant Profiling
Charge variant analysis provides essential information regarding biological drug structure, stability, binding affinity and efficacy. It is now possible to simplify and streamline your charge variant profiling using cation exchange pH gradient buffers which enable fast and robust method development and facilitate method transfer into the QA/QC environment. Read about how to improve quality and time of charge variant profiling in this new application note:
During their manufacturing process and storage, biotherapeutics can form protein aggregates which can significantly impact their safety and efficacy, indeed the analysis of aggregates is mandated by the regulatory agencies. To simplify the analysis of these types of aggregates, unique column chemistries are now available which together with an inert UHPLC system avoids secondary interactions. Check out this application note to see how your aggregate analysis can be improved:
Do you need straightforward insights into the proteoform profile of your life changing biologic? Whether it be native intact, denatured intact or sub-unit mass analysis, one platform now fits all! The Thermo Scientific™ Q Exactive™ BioPharma platform offers distinct operational modes optimized for intact and sub-unit analysis. Read all about it in this poster note from ASMS 2016: