BioPAT® - 8 Pages

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BioPAT®

Catalog excerpts

BioPAT* ChemometricsToolbox New Opportunities for Efficient Bioproeess turning science into solutions

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BioPAT ® Chemometrics Toolbox Increase Efficiency and Assure Quality During the past few years, usage of multivariate methods in development and manufacturing processes has dramatically increased. Especially after the introduction of concepts like Process Analytical Technology (PAT) and Quality by Design (QbD), chemometrics is regarded as a central approach for increasing the efficiency of biotechnological processes and product development. In addition, it is a sophisticated tool for preventing or mitigating the risk of producing a poor quality product. Design of Experiments (DoE) is...

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User-friendly Software for Process Development, Scale-up and Production CLD Strain dev. Virus dev. R&D, early PD Late PD Production Process Development Process Optimization Process Validation Pilot Plant Launch Facility Identify critical process parameters and their optimal ranges and estimate a Design Space BioPAT® MODDE is a state-of-the-art DoE software package that is used by scientists, engineers and statisticians alike to help understand complex processes and products. BioPAT® MODDE enables fast and effective identification of critical process parameters (CPPs) and, subsequently,...

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Upstream Applications Accelerate Development and Optimize Production DoE for optimization of growth and production culture media to identify a better selection and quantitative composition of medium factors CERTOMAT® CTplus MVDA for scale-up evaluation and comparison of cell culture systems to mitigate risk of different scale-up performance and verify the findings of the small-scale studies for generation of process signatures DoE for screening and optimization of basic process variables to define a better physical environment for cell growth and improved protein production Process...

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Downstream Applications Optimize Purification and Establish Robustness DoE for optimization of purification conditions to identify best binding capacity for impurities DoE for robustness studies of crossflow filtration conditions together with MVDA for multivariate statistical purification monitoring Sartobind® Pico SARTOFLOW® crossflow systems Sartobind® Nano DoE and MVDA for robustness and validation studies of virus inactivation with focus on product quality and safety UVivatec® DoE for filterability studies to optimize flow rates for an optimum filtration scheme and material...

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Naturally it is most important for researchers and engineers when developing new products, but we also see it as a way of structuring our experiences and minimising the number of experiments. – Create knowledge around process and quality assays to demonstrate product and process comparability for manufacturing Are you concerned about risk mitigation? – Define design space as “window of operation” for efficient scale-up qualification and ensure a drug product meeting the defined quality – Science- and risk-driven process optimization to determine a manufacturing processes that will ensure...

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During process development, MVDA contributes significantly in a structured way to evaluating and visualising data stemming from lab and pilot scale. We had the most successful experience applying MVDA in a retrospective way. Overall, a 40% increase of yield have been gained. Now, due to this success the installation of an online MVDA control system is planned for the next months. – Assessment, control and ongoing process reviews with focus on product quality and patient safety – Ensure that a process is under control and, consequently, that it meets the quality specifications – Establish...

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Sales and Service Contacts For further contacts, visit www.sartorius-stedim.com Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen Italy Sartorius Stedim Italy S.p.A. Via dell’Antella, 76/A 50012 Antella-Bagno a Ripoli (FI) USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 200 Bohemia, NY 11716 Sartorius Stedim Systems GmbH Robert-Bosch-Strasse 5 – 7 34302 Guxhagen Netherlands Sartorius Stedim Netherlands B.V. Argentina Sartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires Phone +49.5665.407.0 Fax +49.5665.407.2200 France...

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