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Prefilled Syringes & Parental Manufacturing

Summary: The global prefilled syringe and parenteral packaging markets are gaining momentum and growing quickly. Key players within the market are focusing their efforts to ensure products are of the highest quality, safe, and easy to use…

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Designing Optimized, Site-Specific ADCs

Summary: Antibody-drug conjugates have provided a breakthrough in targeted medicines but ways of increasing their stability and efficacy are still required. Historically, the technologies used to build these two approved products result in a heterogeneous milieu of conjugates…

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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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Biopharma Manufacturing Trends

Summary: As pharma companies look more and more to biologics for their next potential blockbusters, they must face the challenges surrounding these products’ scientific complexity and sophisticated development…

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The Ever-increasing Attraction of Biologics

Summary: The field of biologics promises targeted treatments for a range of conditions. For the promise of many of these therapies to become a reality, however, technological challenges must still be overcome, with many exciting novel treatments currently on, or making their way to, the market. This article published in Chemistry World discusses…

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Contractors Take On The Challenge Of Complex Molecules

Summary: The global pharmaceutical analytical testing outsourcing market could reach ~$10 billion in the next decade. Read the latest Drug Development & Delivery report highlighting how the leading service providers are prepared to provide analytical and bioanalytical methods that address the growing market…

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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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Biopharmaceuticals/ Biosimilars Roundtable, APR 2017

Summary: The biopharmaceutical market has seen incredible growth. American Pharmaceutical Review conducted industry round table with experts to share their opinion on the market drivers for growth, limiting factors and critical issues. Read the article to get insights on developing and marketing biopharmaceutical…

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