Search results for "manufacturing" in Articles / App Notes
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
This complexity requires more complex manufacturing processes, according to Kate Keeping, senior director of biosimilars research with Decision Resources. With mAbs, notes Dingermann, glycostructures …
Article
Climate Change in Outsourcing
These developments have placed bio/pharma company revenues under further pressure and have forced continuing cuts in R&D and manufacturing. Government budget cuts also threaten support for pharmaceuti…
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Elucidating Biosimilars Characterization
… bench to launch can be a challenge, not just during the development stage but also in terms of the manufacturing process involved.
BioPharm International spoke with Jonathan Bones, principal inv…
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The Development and Application of a Monoclonal Antibody Purification Platform
After the demonstration run, this process was transferred to the pilot plant for manufacturing clinical supplies.
Early Platform Modifications
The original process was developed at Pfizer fo…
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Evaluating the Use of Continuous Chromatography
As the biopharmaceutical industry strives to demonstrate, continuous manufacturing offers the benefits of higher productivity and better product quality than traditional batch manufacturing. In additi…
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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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What is process development?
Ultimately, you will need a process that translates to a manufacturing environment, one that is easy to scale up throughout clinical trials and to the market. By the time you reach Phase III in the dr…
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Top Process Development Trends for 2021 and a Look into 2022
Further, in terms of manufacturing, because many of these molecules are so large, they are not only sensitive, but they also require closed processing.
AAV is quickly becoming the most flexible an…
Article
Reimagining Affordable Biosimilars
The manufacturing process itself serves as a producer of impurities and thus is a source of product heterogeneity. Characterizing and separating these impurities is essential for ensuring that product…
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Can Vaccine Development Be Safely Accelerated?
Several academic and industrial researchers have also focused on applying novel vaccine development and manufacturing platforms to the accelerated development of a COVID-19 vaccine.
In terms of…