(519e) New Protein ? and Multimodal Anion-Exchange Membranes for the Rapid Isolation and Purification of Biologics

Numerous campaigns are underway to develop biologics for many chronic conditions, but the process from biologics discovery to a commercial medicine is long and expensive. Thus, a key challenge in the industry is to translate biologics from research labs to FDA approved medications more efficiently and economically. Improving purification productivity by increasing the speed and capacity of capture step chromatography columns and achieving process compression by conducting polishing step purification without buffer exchange or dilution steps will play key roles in meeting this challenge.

In this study, we present performance data for Purilogics’ novel Protein A and multimodal anion-exchange membranes and compare results with advanced commercial products. We demonstrate that the Protein A membrane achieves high antibody dynamic binding capacity of >50 mg/mL at 0.6 second residence time and high impurity clearance. We further demonstrate that the multimodal anion-exchange membrane achieves high dynamic binding capacities for protein and DNA at high conductivity conditions and at high flow rates. Under conditions of 13 mS/cm conductivity in tris-base buffer, the new multimodal anion-exchange membrane offers more than twice the protein dynamic binding capacity of two leading commercial membrane products at one-half the residence time. In PBS buffer, it offers >14 times higher dynamic protein binding capacity, and >6 times higher DNA binding capacity. These new membrane columns dramatically increase isolation and purification speeds, which is needed to move biologics from discovery to market faster.