Powerful, Intelligent & Intuitive Mixing For Your cgmp Biomanufacturing

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1 Powerful, Intelligent & Intuitive Mixing For Your cgmp Biomanufacturing

2 Intelligent & Powerful Mixers Ensure Product Quality and Process Efficiency for All Process Steps of Your cgmp Biomanufacturing Media & Buffer Formulation Downstream Intermediates Intelligent & Powerful Drug Substance Drug Product

3 Mixer Quality Attributes Must Fulfill Unit Operation s Requirements to Achieve the Expected Product Quality and Process Efficiency Powerful I Low Shear: lack of strong, high torque Mixing will impact process efficiency; shears may impact product quality Intelligent: lack of in-line process monitoring and control increase risk of process variability and impact product consistent quality or efficacy Intuitive: lack of ease of use can lead to contamination of products and loss of time Large scale: mixers shall offer similar technology from clinical to commercial [...] the impact of bottom mounted mixers on biologics drug product is not yet fully understood and is scarcely reported* Genentech PDA Journal of Pharmaceutical Science and Technology, report «Mixing Monoclonal Antibody Formulation Using Bottom-Mounted Mixers : Impact of Mechanism and Design on Drug Product Quality»

4 Single-use Mixers Increasingly Adopted for All Process Steps million liters of fluid mixed in bags every year incl. drug product, viral inactivation steps cgmp commercial production...but what if... Your product is very shear sensitive? Your powder buffer is not consistently formulated? Your off-line sample is not representative? You need to scale-up to commercial?...you will risk... Product quality with protein aggregation & risk of filter fouling Process variability, product efficacy Off line sampling not representative of the actual status To qualify a new mixer for your commercial manufacturing

5 Intelligent Fast Powder Dissolution Low Shear Intuitive Large Scale Mixing

6 The Powerful Vortex of our Magnetic Mixer Provides Fast Powder Dissolution from 50L up to 3000L Flexel for Magnetic Mixer is a compact and non-invasive mixer Strong magnetic coupling allows high impeller speed and high torque Centered impeller combined with cubical design provide baffle like effect Strong vertical vortex allows instant downward movement and fast dissolution of media floating powders or high concentrated/viscous buffers Fast Buffer and media dissolution 50L to 3000L using the same mixing technology for process consistency during scale-up 2500L PBS 9,6 g/l CHO Media 20 g/l Mixing time (min) Performances proven up to 2 500L

7 The Low Shear of our LevMixer Safeguards Shear Sensitive Products Flexel for LevMixer is based on non-contact magnetic coupling between: conventional permanent magnets in the impeller and superconducting materials in the drive unit Levitating impeller eliminates shear effect or grinding of sensible proteins responsible for particles or aggregates formation [...] the impeller designs of the BMMs* played a critical role in particle formation, which could subsequently foul the filtration membrane to cause major manufacturing disturbances, delays, or even loss of a formulation batch (Genentech) * Bottom-Mounted Mixers

8 You Can Rely on Powerful or Low Shear Mixing Performances to achieve FAST Process and Product Quality for All your Process Steps Bring a fast and consistent powder dissolution Allow efficient mixing of high viscous products Safeguards your shear sensitive protein from aggregates or particles formation responsible of filter fouling > Product Quality > Process Efficiency [...] the impeller designs of the BMMs* played a critical role in particle formation, which could subsequently foul the filtration membrane to cause major manufacturing disturbances, delays, or even loss of a formulation batch (Genentech*) * Genentech PDA Journal of Pharmaceutical Science and Technology, report «Mixing Monoclonal Antibody Formulation Using Bottom-Mounted Mixers : Impact of Mechanism and Design on Drug Product Quality» * BMMs : Bottom Mounted Mixers

9 Our Unique Intelligent Mixers are Designed for Monitoring & Control All Critical Mixing Parameters In-line monitoring & control Pre-assembled singleuse ph probe, conductivity sensor and thermowell [...] quality cannot be tested into products; it should be built-in or should be by design. * Weight & Temperature Control Weighing functions and heat exchange jacket for integrated control of the volume and temperature. Recipe management Real impeller speed Mixing recipes Password management. * Guidance for Industry PAT A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

10 With In-Line Monitoring and Control, our Mixers Provide Consistent Product Quality and Process Efficiency Brings continuous real-time quality assurance and process control > Ensure consistent and pre-defined quality of biological active substance compared to conventional off line QC tests in laboratories Reduce operator time Avoid risk of cross contamination Bring process understanding to manage and predict process variability > Meet the PAT and cgmp requirements > Consistent Product Quality > Process Efficiency > Continuous improvement

11 Our Intuitive Handling Mixers are Designed to Reduce Likelihood of Mistakes and Leaks Cubical design with front doors Convenient installation, deploying and folding of the bag during filling and draining Front access to tubing and sensors Facilitates the filling, sampling and draining operations 8 Top Port Easy and contained powder transfer into the mixing bag

12 The Intuitive Handling of our Mixers Enables Quick start-up & Simplified Operations of Your Mixing Bags in Its Container Reduce likelihood of mistake and leaks Fast set-up and changeover Save operator time Slide 12

13 Our Large Scale Mixing offer similar Mixing Technology for Your cgmp Production Scale Magnetic Mixer and LevMixer available from 50L up to 3000L for large scale commercial production Our Palletank are designed Standard with integrated weighing and heat exchange jacket up-to 2000 L (Custom design up-to 3000L) Excellent Mixing Performance at large scale with the Magnetic Mixer Technology: Mixing performances when dissolving media powders Tests performed by Sartorius Stedim Biotech 13

14 Our Large Scale Mixing offer similar Mixing Technology for Your cgmp Production Scale > Similar Mixing technology from your process development up-to your cgmp Production Scale > Excellent Mixing Performance at large scale with the Magnetic Mixer Technology

15 Powerful, Intelligent & Intuitive Mixers Ensure Product Quality and Process Efficiency for All Process Steps Our powerful or low Shear Mixers achieve fast Mixing and ensure product quality for All your Process Steps With Unique in-line monitoring and control, our Intelligent Mixers provide consistent quality and process efficiency while meeting PAT and cgmp requirements The Intuitive handling of our Mixers enables quick start-up & simplified operations of your Mixing Bags in its Palletank Our large scale mixing offer similar Mixing technology for all your process and cgmp production scales

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