INSIGHTS ON UPSTREAM MANUFACTURING
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How Semi-Targeted Integration Changes The Biologics Game
Modern biologics development requires precise cell line engineering. Semi-targeted integration enables stable, high-producing cell pools faster, accelerating development timelines.
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Recombinant Erwinia Asparaginase Production
When E. coli-derived asparaginase supply failed patients with hypersensitivity, a recombinant Erwinia alternative went from project kick-off to FDA approval in approximately five years.
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Scaling AAV Manufacturing To 1000 L: Strategies For Robust Production
Learn how integrated cell line, media, and process design can support consistent AAV production at larger volumes while maintaining productivity and quality, as well as reducing scale-up risk.
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Driving Productivity Across The Antibody Manufacturing Workflow
Learn how integrated upstream and downstream strategies can reduce harvest bottlenecks, improve purification efficiency, and support scalable therapeutic antibody manufacturing.
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A CFD-Based Hybrid Modeling Approach For pCO2 Prediction9/14/2026
Computational fluid dynamics and metabolic modeling predict gas transfer more accurately than volumetric metrics, improving mammalian cell culture scale-up and process control.
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De-Risking Cell Culture Media Scale-Up For Late-Stage Manufacturing9/11/2026
Explore practical approaches to scaling cell culture media manufacturing, from supply assurance to evolving quality requirements, digital formulation tools, and strategies for controlling costs.
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Reducing Timelines And Development Costs Through Scale Up9/11/2026
See how an engineering-based approach to bioreactor scale-up delivered comparable cell growth, metabolic profiles, and product performance across cell lines and vessel sizes, helping reduce risks.
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Scaling AAV Purification: UF/DF Technologies That Deliver9/11/2026
Examine a data-driven comparison of hollow-fiber and flat-sheet TFF technologies for AAV manufacturing, covering process performance, scalability, engineering considerations, and cost.
UPSTREAM MANUFACTURING SOLUTIONS
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Rushing early development without planning for commercialization can lead to delays. Aligning process and analytical strategies from the start supports efficient scale-up and smoother manufacturing.
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A stable producer cell line platform designed to replace transient transfection in AAV manufacturing, offering 10 to 15-fold titer improvements and simplified workflows from development through commercial scale.
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Used 500 liter Cytiva XDR-500 bioreactor system, model XDR-500. Includes (2) Rosemount Analytical model 1056 dual channel intelligent transmitters and (4) peristaltic pump heads, serial# XDR-08825-001, built 2011.
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Used 500 liter Sartorius Biostat CultiBag single use bioreactor, model STR 500 DW, stainless steel bag holder with agitator drive, jacketed for 1 bar, control system with hmi touch screen, serial# STR-0550, built 2016.
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Used lot of (2) 10 liter GE Xcellerex (Cytiva) single-use stirred tank bioreactors, model XDR-10. Includes Emerson model 1056 controllers and Mettler Toledo model PBA655-B60 20" x 16" platform scales, serial# 29188443 & 29188442, built 2016.