Search results for " start" in Articles / App Notes
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…
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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 …
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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…
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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.…
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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 …
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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,…
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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…
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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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Best Practices in Qualification of Single-Use Systems
The implementation of SUS usually starts with development of the user requirement specification (URS). Typically, the development engineers at biopharmaceutical companies then work closely with the de…
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Selecting a Comprehensive Bioburden Reduction Plan
Souza: Planning the design of a comprehensive bioburden reduction strategy should start with risk assessments for each of the entry routes. The identified risks and severity levels inform planning of …