Enabling the Future: Why Innovation in Purification Media Is Essential for Next-Generation Biologics

Introduction

As biopharmaceutical pipelines become more diversified, and development timelines shrink, the pressure on downstream processing (DSP) to keep pace and deliver optimal results has intensified. Monoclonal antibody (mAb) production dominated the industry and drove the optimization and standardization of highly platformed DSP technologies, most notably Protein A chromatography for capture and a standard suite of polishing steps.
These processes, while robust and regulatory-proven, were not designed to handle the molecular heterogeneity and specific purity requirements presented by new classes of therapeutics.
New biological modalities such as bispecific antibodies, drug conjugates, fusion proteins, viral vectors, and nucleic acid-based drugs have unique physicochemical profiles that challenge the capabilities of legacy purification solutions. Purification of these new biological modalities require tailored strategies, molecule-specific process development, and greater selectivity.
Compounding this are broader industry trends toward more efficient processes, heightened sustainability expectations, and the need for greater supply chain resilience.