As single-use technologies have grown in importance and acceptance, offering more solutions every year, their biggest challenges have come in downstream separation, purification, and processing that follows product expression in cell culture. Many technologies in downstream processing present technical and economic problems. Authors in this featured report delve into many of these issues and innovations. They discuss automation, depth filtration, continuous processing, alternatives to resin chromatography, and fill and finish technology.
Introduction: Downstream Disposables —
The Latest Single-Use Solutions
for Downstream Processing
The senior technical editor provides an overview of the challenges of downstream processing and single-use technologies. She includes discussion of innovations in filtration, centrifugation, alternative solutions, chromatography, and final formulation, fill and finish. This article features an automated depth filtration sidebar by guest author Guy Matthews.
Single-Use Depth Filters: Application in Clarifying Industrial Cell Cultures
Given the high cell densities achievable with both mammalian and microbial cell culture processes, primary recovery can be a significant challenge. The authors discuss single-use technologies for harvest clarification — centrifugation, tangential-flow filtration (TFF), and depth filtration — with their different advantages and disadvantages. Through data comparison, the authors conclude that the most promise for resolving processing issues and cost comes through the use of depth filtration.
Multicolumn Chromatography: Facilitating the Commercialization of Monoclonal Antibodies
The downstream processing group at CMC Biologics recognized a need to find alternative processing methods to reduce the cost of protein A capture chromatography. Because of its cost, this step often can be a financial barrier for some pharmaceutical innovators looking to get new drugs to the clinic. The authors delve into prepacked single-use chromatography columns and continuous processing in the commercial production of monoclonal antibodies.
Membrane Adsorbers, Columns: Single-Use Alternatives to Resin Chromatography
Membrane chromatography can reduce operational time, cost, and complexity while maintaining high levels of production output per week for commercial biomanufacturing. This technology is coming of age. Here, authors from Natrix Separations take the stance that membrane adsorption in downstream processing is the future of highly productive, flexible manufacturing for clinical and commercial protein production.
Single-Use Fill and Finish: An Interview with NNE Pharmaplan
Senior technical editor, Cheryl Scott talked with NNE Pharmaplan’s Kim Vincent Andersen (single-use technology and biotechnology specialist) and Niels Guldager (global technology partner in biotech) to discuss their experiences with single-use technology in client facilities. In particular, they highlight a recent project for Novo Nordisk that involved a large-scale greenfield filling and inspection facility in Hillerød, Denmark.