Search results for "Scale down"
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Performance of Single-Use Xcellerex™ XDR‑500 MO and XDR‑50 MO Stirred-Tank Fermentor Systems
This application note describes the performance of the XDR‑500 MO fermentor system in comparison with the XDR‑50 MO fermentor. Domain antibody production in E. coli was used as the model process. …
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Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
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Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
Buffer preparation is both time-and space-consuming and can easily become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-li…
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From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …
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Fusion Proteins Pose Manufacturability Challenges
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
By Cynthia A. Challener
Fusion proteins are engineered proteins that contain domains from di…
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Improvements in Protein A Chromatography
Process Development Forum speaks about Protein A chromatography with Glen Bolton, Scientific Director at Amgen. Bolton recently published a paper “Role of more than 40 years of improvement in Protei…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
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Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …
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Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …
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Development of column packing methods based on pressure flow measurements
Scale-up of a chromatography process might appear as simply increasing the column diameter to accommodate for the higher quantity of material to be processed, while maintaining the same bed height …