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ADCS – The Dawn Of A New Era?

Summary: The technology behind antibody-drug conjugates (ADCs) has been around for many years, but key learnings in the clinic have furthered our understanding…

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Biologics Development

Summary: Catalent Biologics provides comprehensive services to meet complex biologic development needs. Click to see our global locations and services…

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Continuous Processing In Biomanufacturing

Summary: As the biologics industry continues to grow, biopharmaceutical companies are evaluating continuous processing as a potential means to improve efficiencies. There are many factors to consider when determining whether continuous processing should be adopted, and if so, what adoption strategy should be used…

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The Next Step In Homogeneous Bioconjugate Development

Summary: Bringing a new biologic drug to the market is a long and expensive process with R&D cycles that can span more than 15 years and cost over a billion dollars. Nonetheless the pharma industry is increasingly shifting efforts to focus on these types of compounds…

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ADC Development Using SMARTag™ Technology

Summary: Bioconjugates are an emerging class of biologics that combine the favorable properties of proteins, such as specificity and the ability to target distinct protein interfaces, with the advantages of synthetic small molecules, such as potency, bioavailability, and synthetic tractability. Early examples of bioconjugates include proteins linked to…

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Viral Clearance For Biopharmaceutical Downstream Processes

Summary: Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies…

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Generating Aldehyde-Tagged Antibodies

Summary: This article is a selection of articles published in BioMed Central Ltd., giving overview on the ability to site-specifically conjugate a protein to a payload of interest has found widespread application in basic research and drug development…

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New Ideas For Antibody-Drug Conjugate Design

Summary: This article is a selection of articles published in The Scientist, giving overviews on new ideas for antibody-drug conjugates designs so oncologists can aim a chemical payload at any cell for which they can identify a specific antigen, such as the HER2 receptor on breast cancer cells…

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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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Antibody-Drug Conjugates – Where Are We Now?

Summary: In October 2015, during CPhI World Wide in Madrid, Spain, Oncology Tube from InPress Media Group, LLC. asked experts from Piramal Pharma Solutions, Carbogen Amcis and Catalent Biologics about challenges in the manufacturing of ADCs and how they see the market for ADCs evolve…

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