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Chesham, United Kingdom

Fraud N.,Sartorius Stedim North America | Lim J.,Biopharm Services Ltd. | Sinclair A.,Biopharm Services Ltd. | Gottschalk U.,Sartorius Stedim Biotech GmbH
BioPharm International

There has been a rapid uptake of disposable technologies in the biopharmaceutical industry over the last decade, including disposable modules for chromatography. Disposable membrane chromatography has proven to be a powerful alternative to polishing columns, particularly for process-scale monoclonal antibody purification, because of advantages such as high throughput, faster processing time, reduced buffer consumption, and elimination of column packing and packing testing activities. Disposable technologies also allow facilities to run multiple products in a single plant without the risk of cross-contamination between batches. This article demonstrates through, a case study, the practical and economic benefits gained from replacing reusable column chromatography with disposable membrane chromatography. The study looks at the whole process and evaluates the production costs for the stainless steel option, in which all unit operations are performed using stainless steel equipment items, and the disposable option, in which column chromatography is replaced by disposable membrane chromatography and all other unit operations are based on stainless steel equipment items. Source

Pietrzykowski M.,General Electric | Flanagan W.,General Electric | Pizzi V.,General Electric | Brown A.,Biopharm Services Ltd. | And 2 more authors.
Journal of Cleaner Production

Many biopharmaceutical companies have replaced or are planning to replace traditional multi-use facilities (fixed-in-place stainless-steel fermenters, tanks, downstream equipment, and associated piping) with single-use systems to improve flexibility and cost. This article will describe a recentlycompleted comparative study of the environmental impacts of producing monoclonal antibodies using either single use or traditional process technology. The study was performed using Life cycle assessment methodology in which environmental impacts across the entire life cycle of each process component, from materials extraction and refining through component manufacturing, packaging, distribution, use, and disposal at end-of life are all considered. The assessment looked at the production of monoclonal antibodies (MAb) over a 10-batch campaign at three production scales chosen to reflect the clinical phase, scale-up phase, and production phase. The entire process trains were modeled including upstream and downstream processes from N-2 seed fermentation through product purification. Inventory data were derived mainly from Biopharm Services Ltd., developer of BioSolve, an industry standard bioprocess model that includes standard benchmark operations and costs that can be used to build any process including those for manufacture of mAbs, vaccines and bacterial based products. The results of this study indicate that the single-use process train exhibited lower environmental impacts compared to the traditional fixed-in-place process train in each environmental impact category studied. This is primarily due to a reduced need for the energy intensive water-for-injection, process water and clean steam that are required to perform cleaning and sterilization between batches for traditional fixed-in-place equipment. © 2012 Elsevier Ltd. All rights reserved. Source

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