Search results for " start" in Articles / App Notes
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Interestingly, our customers normally purchase a single-use chromatography system before they start using a disposable column. The chromatography system is a long-term commitment to make, whereas a co…
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Challenges and Trends in Biopharma Facility Design
In the case of producing a blockbuster drug, a large-scale stainless steel facility might actually be the most economical choice, especially if you have low titers and are starting from high-volume bi…
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Brazil Emerges as Global Biopharm Collaborator
According to industry associations, biopharmaceutical innovation in Brazil will increase in the future as the country starts facing its challenges and participating globally with local and multination…
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Early Communication with Regulators is Essential for SMEs
It is, however, hard work for the regulatory agencies because many small companies (a high proportion of which are startups founded by individual specialists or small groups of scientists) tend to del…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
The PPB meeting has since the start in Australia in 1999 turned into the “major meeting series” in the arena of plasma fractionation. This eighth PPB meeting, following an island theme, gathered more …
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Elucidating Biosimilars Characterization
Quintiles: The amino-acid sequence of a biosimilar molecule is one of the starting points in determining similarity to the originator medicine, with the draft guidance from FDA implying that a biosimi…
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Quality by design for biotechnology products—part 1
When a product is developed using a QbD approach, the impact of raw and starting materials and process parameters on product quality are well understood and the sources of process and product variabil…
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Life cycle assessment of the protein A process in mAb manufacturing
We are reminded daily of how climate change is affecting our planet, and organizations all over the world have embraced sustainability and started to allocate attention and resources to sustai…
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A Closer Look at Affinity Ligands
Large-scale manufacturing of a therapeutic monoclonal antibody (mAb) starts with the expression of the antibody in mammalian cells, typically CHO [Chinese hamster ovary] cells, followed by a series of…
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Bracing for a Future Wave of Advanced Therapies
If you go back in time to 2019 when FDA … said we could see 10 to upwards of 20 approvals a year starting in 2025, we think that is tracking rather nicely for that time period. It’s conceivable that w…