Search results for " therapeutic" in Articles / App Notes
Article
Antibody Purification Handbook
The diversity of the antibody-antigen interaction and our ability to manipulate the characteristics of the interaction has created many uses for antibodies and antibody fragments, both for immunoche…
Article
GMP Challenges for Advanced Therapy Medicinal Products
56: Application of Phase-Appropriate Quality Systems and CGMP for the Development of Therapeutic Protein Drug Substance (Bethesda, US, 2012).
About the author:
Sean Milmo is a freelance write…
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Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
The latter can be difficult to detect, grow to high densities without adverse effect on cell morphology, and can impact a wide variety of cell functions, including changing response to therapeutics (1…
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Since the first therapeutic antibody came onto the market in 1986, up to the end of 2014, 47 products have been approved in the United States or Europe for a number of diseases including various types…
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Biopharma Advances Demand Specialized Expertise
Due to the complexity of many biopharmaceuticals, their development and success as therapeutics requires a comprehensive range of scientific disciplines and expertise, which can be difficult to fully …
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Optimization of Protein Expression in Escherichia Coli
May 01, 2015
By Siavash Bashiri, David Vikström, Nurzian Ismail
BioPharm International
Volume 28, Issue 5
Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…
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FDA Approves First Biosimilar
To date, there are a total of five 351(k) applications that are publicly disclosed, including the one for Zarxio, said Leah Christl, associate director for therapeutic biologics and biosimilars in the…
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The Bullish Outlook for Biosimilars
Taking this approach will raise the bar on what it takes to be “market similar” by forcing new entrants to demonstrate how their product adds value through both its therapeutic and service characteris…
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What Drove Biopharma Development in 2014?
In addition to developing quality biopharmaceuticals, manufacturers continue to create innovative medicines for treating various diseases, thus driving the trend of next-generation antibody-based ther…