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Article Simplify chromatography method creation
To save time and effort, method creation can be simplified and you can get to the point where you can start the run quicker. Efficient method creation is often about finding useful tips on how to deve…

Article Analysis of Glycosylation in Biosimilars
The starting point is those methylated structures, which are acid-cleaved to produce monosaccharides with free hydroxyl groups where the links were split. A reduction step converts the hexoses to line…

Article Biosimilars: Making the Switch Comes with Challenges
At the start of EMA’s regulating of biosimilars, there were doubts about whether the existing analytical methods for characterizing biologicals, especially complex ones, were adequate, said Martina We…

Article Fast Turnaround with Automated Column Packing
Packing success from the start Today it is possible to get packing right on the first try. Automated columns can help save both time and labor costs. AxiChrom™ columns have been designed for easy …

Article Continuous Processing for the Production of Biopharmaceuticals
Process development in the batch mode is the starting point; this is because if for the existing processes the batch protocol is already developed and validated, the motivation is to continue to use t…

Article Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
In a standard culture process, once cells have attached to the culture support, they undergo a lag phase and then start growing exponentially at a high metabolic activity, until confluency is reached.…

Article A Q&A With Jeff Carter on Trends in Single-Use Technologies
Because the BPOG protocol has at least a two year head start on a protocol from a voluntary standard setting body, we can potentially end up in a situation with two best practices. We will likely see …

Article Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
When a new host-cell line is introduced, the starting point for the process will usually be the existing platform process that was originally designed for the previous host-cell line. In this example,…

Article Implications of Cell Culture Conditions on Protein Glycosylation
Protein therapeutics and cell-culture effects on protein quality Biopharmaceutical drugs are proteins with polymeric structures, built up in a series of structural levels starting from the amino-ac…

Article Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Late-stage development starts with set up and validation of analytical methods and with securing reagents (8–10) for the analytical program. A broad range (50–60 variants) of different analytical tech…

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