Improving Routine Biotherapeutic Analysis: Some Things Work Better Together

By Scott J. Berger, Sr. Manager, Waters Corporation

It’s become clear that all elements of an analytical workflow contribute to the quality of the resulting data and the efficiency in which that data can be acquired. Beyond improvements in data quality, well-reasoned and executed laboratory workflows minimize assays failures, reduce validation costs, and facilitate efficient method transfer between laboratories.

Taking these capabilities further is necessary to realize the full vision of many companies and regulators to transform their existing analytical assays into modern platforms capable of direct measurement of biotherapeutic attributes. It is suggested by both regulators and biopharmaceutical companies that the shift to multiplexed direct attribute-based measurements will increase the quality and quantity of the product and process information that companies must have to make a safer and more consistent product.

In this blog we describe how the BioAccord LC-MS System has proven to be a disruptive force for improvement in routine biotherapeutic analysis. It provides high-performance analytics to non-MS experts, along with waters_connect informatics, enabling the biopharm industry to readily deploy these integrated technologies into regulated development, manufacturing, and quality organizations.