Author Archives: Jie He

Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics

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Part 1 of this article focused on the first two sessions of a CASSS chemistry, manufacturing, and controls (CMC) forum entitled “Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies,†which took place on 16–17 July 2018 in Gaithersburg, MD. Those sessions focused on upstream and downstream process technologies and strategies (1). Part 2 highlights the final two conference sessions on process modeling, control, and analytics. Process Modeling and Control The third conference session was “Modeling and Control Strategies.†Advancements in…

December 17, 2020

Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies

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Future biomanufacturing must address industry drivers, including the need for decreasing cost of goods (CoG), increasing market globalization, shortening development time for pipeline products, reducing risk to patient supply, and improving product quality. A CASSS chemistry, manufacturing, and controls (CMC) forum entitled “Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies†took place on 16–17 July 2018 in Gaithersburg, MD, to address those opportunities. Advanced technologies include single-use bioreactors, alternating tangential-flow (ATF) systems used during fermentation, modular and closed process equipment,…

October 29, 2020

A Scalable Immobilized Metal Affinity Chromatography Resin for Process Purification

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Downstream process purification of proteins requires a resin with optimized bead size for ideal pressure/flow properties and decent dynamic binding capacity (DBC) that provides production efficiencies and good process economics. Our newly developed metal chelate affinity resin — Nuvia™ IMAC — provides the mechanical strength, pore structures, ligand density, and particle size distribution required for an operation run at 300 cm/hr with a DBC of > 40 mg/ml at < 2 bar column backpressure. Protein purification can efficiently be scaled…

December 20, 2016