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Top BioPharm International News Stories of 2017
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
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A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
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The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.
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FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.
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The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.
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Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt.
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UC Berkeley appealed the February 2017 decision that determined Harvard and MIT’s Broad Institute and Berkeley’s CRISPR-Cas9 technologies were separately patentable.
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The White House said President Trump will nominate Scott Gottlieb to the position of FDA commissioner.
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The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the institution to keep patents for its CRISPR-Cas9 gene-editing
technology.
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A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.
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Top BioPharm International Feature Stories of 2017
There is much work to do to achieve efficient, cost-effective production processes.
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Excipient selection strongly influences lyophilization performance for biologic drugs.
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Despite limitations, mass spec is having an impact on biologic drug development and manufacturing.
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The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.
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The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
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For cellular materials, new ultra scale-down devices inform large-scale downstream processing techniques.
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This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
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The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.
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The authors review how media components modulate the quality of monoclonal antibody products.
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This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Events
February 7–8, 2018
February 11–14, 2018
March 12–14, 2018
more events
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eBook
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.
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