Search results for " process"
Article
Process Chromatography Selection for Downstream Processing Applications
Important factors such as column design, resin development, and automation have all played a role in simplifying the purification process, in some cases reducing it from five steps to three (1). Selec…
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Maximum Output Starts with Optimized Upstream Processing
That includes the supply of key inputs to upstream processes as well.
As a result, a strong and sustainable supply network is more vital to ensure supply chain stability, according to Youngsun Kim…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
We also discuss scale up for processes where analytics intergrate with automation teams with the communications and networking teams. Balancing critical process parameters against competing requiremen…
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Process Chromatography: Continuous Optimization
Challener
Cell-culture and fermentation are high-yielding processes that effectively produce complex biologic molecules with desirable bioactivities. Even so, there are many impurities presen…
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Aseptic Processing: Keeping it Safe
Aseptic processing has garnered some increased scrutiny from FDA in recent years, primarily because it is considered a high-risk activity by the agency, says Rainer Newman, consultant at Aseptic Proce…
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What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recombinant protein, viral vector, or other produc…
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Using Digital Twins to Model Process Chromatography
By Jennifer Markarian
A digital twin is a model of a process that allows process development experiments to be run in silico—on a computer—rather than on actual lab or manufacturing equipment. Alt…
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Only few experimental data are needed to calibrate the model to the particular process. Since natural laws are generally valid, mechanistic models can extrapolate far beyond the calibration space. Aft…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Buffers and salts are typically the largest constituents by volume used in the downstream processing steps for manufacturing most biopharmaceutical products. A typical monoclonal antibody (mAb) proces…
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Downstream Processing for Cell-Based Therapies
…opment, significant focus has been directed toward the development of scalable, robust manufacturing processes. Much of the research and development activity in the sector has addressed the upstream …