Biosimilar App Notes & Case Studies
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Performance Of MobiusĀ® Bag Assemblies With UltimusĀ® Film In Truck Shipping Simulation Test
10/29/2024
Explore findings from a study testing Mobius® single-use bags under rigorous shipping conditions, demonstrating the suitability for transporting various liquid volumes while preserving their integrity.
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Optimizing The Formulation For A Monoclonal Antibody
8/21/2023
An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.
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Accelerate Process Development With Automated Aseptic Sampling
5/6/2024
Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.
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Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer
11/21/2024
Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.
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Improving Bioprocess Monitoring And Control With Multivariate Data Analysis
12/9/2024
Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
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Accelerating The mAb Formulation Process
5/7/2024
Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.
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Adapting Single-Use Chromatography To Manufacturing Scale
5/16/2024
Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.
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Optimizing TFF And SPTFF For High-Concentration mAb Formulations
4/9/2025
Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.
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Lentiviral Vector Production Using Single-Use Bioreactors
5/6/2024
Here, we outline a scalable and robust upstream process developed for LVV production of HEK293T cells and demonstrate how to expand HEK293T suspension cells.
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Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing
6/14/2024
Explore data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.