Search results for " process"
Article
Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…
Article
Factors Which Impact mAb Process Scale-Up
Thinking about your mAb scale-up processes early on can help avoid common pitfalls. Fast Trak™ scientists discuss factors that can influence a successful scale-up outcome.
Article
A New Paradigm in Process Development
Accelerate biologic manufacturing of mAbs, vaccines, and novel biotherapies. Download this e-book for case studies and insights from Janssen, Roivant Sciences, and mAbxience.
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Poster
Scaling In-Line Buffer Preparation from Process Development to Manufacturing
At the same time, process changes in biomanufacturing require downscaling models. This poster demonstrates how ÄKTA™ avant can be used to replicate the BioProcess™ IC System in bench scale.
Poster
Scalable Continuous Chromatography Process for Enhanced Efficiency in Biomanufacturing
The cost pressure on biopharmaceuticals drives the industry toward exploring process intensification options that will maintain or improve quality, stability, and manufacturability of the product wh…
Article
Full Single-Use Downstream Process? Not Any Time Soon.
But where we see full single-use upstream processes, downstream is often a hybrid solution. Here’s why SUTs will not completely replace reuse systems in the near future.
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Article
Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
Article
Bioburden Entry Points in Downstream Processing
If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, for…
Article
Single-use technologies in downstream process intensification
In bioprocessing, thorough cleaning is critical in order to take full benefit of the resin by removing impurities. When using conventional chromatography solutions, cleaning and cleaning validation …
Article
Capto™ Core 700 in Vaccine Processing
The aim with this white paper is to discuss the advantages of using Capto Core 700 in virus purification compared to size exclusion chromatography (SEC), a technique commonly used in several vaccine…