Case Study
A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
Summary: Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability...
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Article
New Techniques for Analytical “Bioassay” Cell Banking
Summary: The creation of a reliable bioassay requires dependable master and working analytical cell banks. In this interview with Pharmaceutical Technology, Michael Sadick, Ph.D., principal scientist at Catalent Biologics, explains...
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eBook
Advances in Analytical Technology for Biopharmaceuticals
Summary: As the biologics industry grows, new analytical techniques are being developed to meet changing needs. This ebook discusses advances in analytical techniques for biopharmaceuticals.
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Article
Enabling Higher Post Protein A Product Purity Using Novel Chromatographic Clarification
Summary: In the recent years, multiple optimizations and advances have been made to the classic antibody generation process to make it scalable, reproducible, and commercially viable. This article describes a strategy to get consistent highly pure products...
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Article
Novel Analytical Techniques For Monoclonal Antibodies
Summary: With the rising interest in biopharmaceuticals, drug developers need to quickly understand and evaluate the binding of therapeutic antibodies to Fc receptors. In this interview with Pharmaceutical Technology, Michael Sadick, Ph.D., and Dan Papa, Ph.D., of Catalent Biologics, talk about a new analytical testing panel...
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Webinars
Accelerating Method Transfer: Effective Automation Of Biological Assays
Summary: Bioassay automation offers ergonomic relief for scientists, consistent method execution, increased throughput, and reduced full-time equivalent expenditure. Importantly, successful automation programs allow unparalleled efficiency in method transfer to receiving laboratories. oderated Q&A roundtable...
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Article
Single-Use Bioreactors Pose E&L Challenges
Summary: Read the recent roundtable Q&A published in BioPharm International featuring biopharma executives discussing the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process...
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eBook
Biosimilars: Getting Cheaper Biologics To The Market
Summary: The opportunity for new antibody biosmilar products is clear. By the end of this decade key patents currently protecting five monoclonal antibodies, each with sales in the neighborhood of a billion dollars a year will have expired, and companies are queuing up for a piece of the market...
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Webinars
Virus Safety Of Biopharmaceuticals: Risk Mitigation During Upstream And Downstream Operations
Summary: From a virological safety standpoint, biopharmaceuticals have had an excellent safety record. This can be attributed to regulatory and industry initiatives that have worked synergistically...
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