Innovation Standardized – Bioseparation Methods For Biotherapeutics

By Nick Zampa, Principal Product Marketing Manager, Waters Corporation

The goal of biopharmaceutical development is to deliver high quality, safe, and efficacious treatments to patients. Reduced risk and increased efficiency afforded by appropriate standardization serves this goal. This article discusses the most impactful standards in liquid chromatography (LC) for biotherapeutics.

Standardization is a critical part of the innovation process. When an innovation proves itself, it can become the standard. And that’s when an innovation maximizes its impact on users. Having a standard starting point to adapt to own’s needs reduces the effort to develop methods, thereby accelerating development.

Standardization in columns and methods have led to critical innovations in chromatographic separation of biotherapeutics. A standard column architecture, some standardized designs, standardized methods, and standards to benchmark those methods and columns, have enabled focus on process, QC, and supply chain improvements that lead to higher quality, more robust, and more easily validatable solutions.