Search results for "biopharmaceutical"
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Best Practices in Qualification of Single-Use Systems
Typically, the development engineers at biopharmaceutical companies then work closely with the design engineers and application engineers from suppliers to select components and standard assemblies as…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Particle-detection methods
There are various detection technologies that should be used to address protein aggregation needs at various phases of the biopharmaceutical development process; however…
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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…
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Relationship Building at Top of Mind for Clients
As results from BioPlan Associates’ 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1) show, however, it’s no longer enough for CMOs to lay claim to technolog…
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Q&As with Industry Leaders
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Dr. Tobias Hahn, co-founder and CEO of GoSi…
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Raw Material Variability
Sometimes the supplier is a big company selling materials to many industries and biopharmaceutical manufacturing is a small part of their overall business. In this case, their willingness to help coul…
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EMA Collaborates with HTA Assessment Networks
The licensing of a new drug is only a preliminary step in what can be a lengthy and complex procedure for some pharmaceutical companies, particularly those with innovative biopharmaceuticals. First a …
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
With the aim of helping to stimulate the global development of these medicines, the EU has opted for more flexibility in the choice of the original biopharmaceutical or reference product to which biop…
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Evolution of the Monoclonal Antibody Purification Platform
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline, as well as revenue, of major biopharmaceutical companies (1). What is unique about mAbs from a processing pers…
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Operational Excellence: More Than Just Process Improvement
However, that approach forgoes the improvements in efficiency, reliability, and the reductions in costs biopharmaceutical organizations can ill afford to sacrifice. And the result of gold plating will…