Tangential flow filtration, also known as cross-flow filtration, is a highly useful downstream processing technique used in bio-manufacturing and also in the upstream process of cell harvesting (separation of cells from fermentation broth). It involves the introduced solution passing tangentially along the surface of the filter, with the pressure difference guiding constituents smaller than the pores through the filter. Tangential flow filtration is utilized in the separation and purification of a wide range of biomolecules such as antibodies, nucleic acids, and recombinant proteins. One advantage rendered by this technique is its ability to be applied to a wide range of biological fields such as immunology, protein chemistry, molecular biology, biochemistry, and microbiology, besides its adaptability to a range of volumes for separation and purification.
Tangential flow filtration is used to concentrate and desalt sample solutions ranging from 10ml up to thousands of liters. It offers several advantages such as easy scale-up and scale-down, effortless set-up and running, and conservation of time and money. This market is motivated by factors such as a rise in the manufacture of biologics, investments by major pharmaceutical companies and CMOs into newer facilities to accommodate the growing demand for biologics, and a requirement for efficient and economical technologies in downstream processing in bio-manufacturing. However, the market is also likely to be curbed by the presence of competing technologies such as centrifugation, direct flow filtration, and pre-coat filtration. The present market dynamics have shaped the need for new manufacturing facility designs which are flexible and exhibit high productivity to enable low-cost scale variations in a smaller footprint. This could be readily addressed by disposable single-pass tangential flow filters. Thus, newer products such as disposable technologies have tremendous potential to augment the development of tangential flow filtration during the forecast period.
The tangential flow filtration market has been segmented on the basis of type of technology, type of product, end-user, application, and geography. Its technology-based divisions are ultrafiltration and microfiltration, while the product-centered ones are disposable tangential flow filtration systems, multi-use tangential flow filtration systems, and TFF filters (cassettes and cartridges), accessories, & spares. In terms of end-user, the market is divided into the following categories: biopharmaceutical organizations, academic & research institutes, CROs, and CMOs. The CMO segment is likely to progress due to the increasing outsourcing activities with respect to the manufacture of biologics. The primary revenue contributor, however, is anticipated to be biopharmaceutical organizations.
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Based on geography, the market is distributed over the following regions: North America, Europe, Latin America, Asia Pacific, Latin America, and Middle East & Africa. The market in North America is projected to be the leader, owing to the adoption of cutting edge technologies coupled with a favorable clinical trial scenario here. The single-use tangential flow filtration systems typically find widespread usage in start-ups and CMOs engaged in the production of biologic molecules for clinical studies. Asia Pacific represents a pharma emerging market which is progressively recording sound growth in the production of biologics, especially biosimilars, and is anticipated to be attractive for the business of tangential flow filtration systems. New products are also estimated to play a role. For instance, in January 2016, Sartorius Stedim launched a tangential filtration system suitable for scaling studies and low volume ultrafiltration over a wide range of surface areas. The system displayed the advantage of applicability to a wide range of bioprocessing domains such as purification of vaccines, monoclonal antibodies, recombinant proteins, and other cell derived components. Moreover, its ability to be used for scale-down models leads to a cost-efficient approach to R&D optimization and cGMP production. Such TFF solutions positively propel the market.
Key players operating in the tangential flow filtration market include Danaher Corporation (Pall Corporation), Merck KGaA, GE healthcare, Spectrum Inc., Parker Hannifin Corp., Novasep, TangenX Technology Corporation, and Sartorius AG.