Search results for " biopharmaceuticals"
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Best Practices in Qualification of Single-Use Systems
Hershenson, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals (Wiley, 2010).
15. L. Ducry, Antibody-Drug Conjugates (Humana Press, 2013).
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Detecting Protein Aggregates and Evaluating their Immunogenicity
According to Lockner, with AUC, the amount of method development needed is minimal, as biopharmaceuticals can often be analyzed in the formulation buffer as it exists in the vial. Because AUC can prov…
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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
Even small-market biopharmaceuticals typically involve sales of at least $200 million/year, such that each delayed work day in getting a product to market can represent a loss hundreds of thousands of…
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Q&As with Industry Leaders
Discovering the unknown: How does in silico process development change PD scientists’ work?
Jeanne Linke Northrop, BioPharm International
Nora Ketterer, Manager, Modeling Services…
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Raw Material Variability
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
It would seem that raw materials used in bioprocessing operations are a relatively straig…
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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
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
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Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
Life-sciences companies face more pressure than ever to reduce costs and increase eff…