Characterization of Xcellerex XDM and XDUO single-use mixers Intellectual Property Notice: The Biopharma business of GE Healthcare was acquired by Danaher on 31 March 2020 and now operates under the Cytiva™ brand. Certain collateral materials (such as application notes, scientific posters, and white papers) were created prior to the Danaher acquisition and contain various GE owned trademarks and font designs. In order to maintain the familiarity of those materials for long-serving customers and to preserve the integrity of those scientific documents, those GE owned trademarks and font designs remain in place, it being specifically acknowledged by Danaher and the Cytiva business that GE owns such GE trademarks and font designs. cytiva.com GE and the GE Monogram are trademarks of General Electric Company. Other trademarks listed as being owned by General Electric Company contained in materials that pre-date the Danaher acquisition and relate to products within Cytiva’s portfolio are now trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva. Cytiva and the Drop logo are trademarks of Global Life Sciences IP Holdco LLC or an affiliate. All other third-party trademarks are the property of their respective owners. © 2020 Cytiva All goods and services are sold subject to the terms and conditions of sale of the supplying company operating within the Cytiva business. A copy of those terms and conditions is available on request. Contact your local Cytiva representative for the most current information. For local office contact information, visit cytiva.com/contact

Characterization of Xcellerex™ XDM and XDUO single-use mixers Introduction Table 1. The tested volumes for each mixer Xcellerex single-use mixers (XDM and XDUO) are available in several different configurations and range in size from 50 to 2500 L. In common for all configurations is the robust mixing performance and ease of use. The mixers are designed for process development, commercial and clinical production of biopharmaceuticals, vaccines, and other biologics and they support upstream and downstream applications for preparation of buffer, media, product and intermediates, as well as other...

The mixer bag was filled with liquid to the volume to be tested (minimum and nominal volumes, Table 1). For the tests at 1 cP, purified water with 0.1 M NaCl was used as liquid. Sucrose and NaCl dissolved in purified water was used to generate a liquid with a viscosity of 20 cP and a NaCl concentration of 0.1 M. The stirrer was set to CCW stirring at 175 rpm. Temperature was set to 20°C. For pH change induction, dilute acid (0.2 M HCl in purified water or 20 cP sucrose) was added at a ratio of 1:2667 for 1 cP and 1:1000 for 20 cP of the liquid volume in the mixer. For accurate pH mapping and...

The results for the whole range of mixers can be seen in Figure 4. 4 Effective liquid-liquid mixing Liquid-liquid mixing was tested at minimum and nominal volumes and at two different viscosities; 1 cP and 20 cP. In Figures 5 to 8, results are shown from the probe position with the longest tm95 determined for each run, that is, the worst-case scenario. The pH data has been normalized to determine tm95. Mixing was achieved within 30 s for all mixer sizes at the tested conditions. The results of the liquid-liquid study are summarized and plotted as a bar chart in Figure 9. Fig 8. Normalized pH...

Solid-liquid mixing PBS mixing in less than 2 min Mixing times of HyCell CHO at minimum and 90% of the nominal volumes in XDM 50 and XDM/XDUO 200 are shown in Table 3. Stirrer rates of 100 and 200 rpm were used at the minimum and nominal volumes, respectively. The normalized conductivity data from the mixing is shown in Figure 11. Mixing times for PBS at minimum and nominal volumes in XDM 50 and XDM/XDUO 200 are given in Table 2. Stirrer rates of 100 and 200 rpm, which are representative of mixing speeds used in bioprocessing, were used at the minimum and nominal volumes, respectively. Normalized...

Conclusions This characterization study demonstrates the performance of Xcellerex single-use mixers in the preparation and handling of solutions in multiple applications and conditions. Heating of liquid from 5°C to 20°C and 20°C to 37°C was generally achieved within 2 h; cooling from 37°C to 20°C and 20°C to 5°C was also achieved within 2 h for mixer sizes up to 200 L. Cooling times for XDM/XDUO 500 varied between approximately 3 and 4 h. Robust and consistent liquid-liquid mixing was achieved within 30 s for all mixer sizes and liquid viscosities tested. In the solid-liquid mixing, effective...

GE Healthcare Bio-Sciences AB Björkgatan 30 751 84 Uppsala Sweden GE, the GE Monogram, HyCell, HyClone, and Xcellerex are trademarks of General Electric Company. © 2016 General Electric Company. TR 29232463. All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information. GE Healthcare UK Ltd., Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK GE Healthcare Europe GmbH, Munzinger...