Author Archives: Marty Siwak

A Novel Chromatographic Technology: Enhancing Performance Utilizing a Modular, Lattice Supported Resin Bed

This poster highlights the Chromacassette® Technology: First practical modular chromatography platform. Supported-bed enables packing of any resin bead. Constant bed permeability, independent of resin compressibility even at V > 1000 cm/hr. Truly linear scalable. Eliminates packing methods and equipment. New operating domains and resin design are now possible for both bind and elute and flow-through. Hyper-Productive™ process enabling for single-use chromatography. PD devices will be available early 2018.

Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar (Trastuzumab)

Four Protein A resins from leading industry vendors, including Amsphere™ A3, were screened for use in a capture step for a Herceptin biosimilar. Multiple parameters were assessed for their performance against the platform resin. Initially, a dynamic binding capacity (DBC) determination was made using a standard 4-minute residence time (RT) using purified protein. Performance of the resins were then screened for recovery and purity using harvested cell culture fluid (HCCF) where the MAb load was 80% of DBC at 10%…

Platform Purification of Six Biosimilar Molecules Using Amsphere A3 Protein A Resin

Currently more than 70 biosimilar monoclonal antibodies (MAbs) are under development, and multiple originator MAbs are going off patent in the next three to four years. Protein A affinity media material remains the most important workhorse for the purification of monoclonal antibodies. Protein A media has a high impact on both development and manufacturing costs, particularly during early stage clinical phases. This note summarizes key performance parameters for JSR Life Science’s Amsphere A3 high-capacity protein A resin for six biosimilar…