Search results for " method"
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Design of experiments (DoE) provides a statistics-based methodology to identify and define factors affecting the overall process or end product. By studying multiple factors simultaneously, DoE allows…
Article
Aseptic Processing: Keeping it Safe
In this case, method development for detection and qualification of the leachable in the product solution would be required once the compounds of concern have been identified.”
Filter integrity te…
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Taking a “Development-by-Design” Approach to Cell Therapies
Grant, Building Deliverable Cell Therapeutics: A Methodical Approach to Manufacturing Development
(Webinar, Oct. 22. 2014).
Agnes Shanley is senior editor of BioPharm International.
Equi…
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Vaccine Development and Production Challenges Manufacturers
Researchers are looking for formulations that reduce cold-chain requirements, methods to boost process yield, and new approaches to document product quality.
Some global health advocates, however, …
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SEC in the Modern Downstream Purification Process
Despite the relative predictability of SEC separations, method development at small scale is crucial to ensure a smooth transition from the bench- to manufacturing-scale operations.
With SEC, it i…
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FDA Approves First Biosimilar
Amgen is suing Sandoz for patent infringement (covering a method of using filgrastim to treat a disease requiring peripheral stem cell transplantation), unfair competition, and conversion, and tried t…
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Technologies and Practices Must Evolve to Meet Demand
Other chromatography methods, spectroscopy, and disposable sensors were used by more than 40% of those responding.
Continuous advancement
The survey responses reveal that continuous manufactur…
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Securing the Single-Use Supply Chain
Both methods may be acceptable depending on the end-user’s specifications.
The challenges of complexity and cost
There are numerous challenges when considering true dual sourcing, and many rel…
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Trends in Single-use Bioreactors
Ang (Eppendorf): Certain single-use systems are capable of continuous or perfusion processes as long as there is some mechanism or method to withdraw cell-free media. Eppendorf’s BioBLU single-use ves…
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Optimizing Resin Performance with Disposable Chromatography Solutions
The robust packing methods that we use have enabled us to ship resins known to be difficult to pack, such as Bio-Rad’s ceramic hydroxyapatite type resin and EMD Millipore’s ProSep. At Repligen, we hav…