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Top Stories
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product's biologics license application.
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The acquisition will boost Bayer's cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.
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Industry News
South Korea's pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.
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NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.
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Biopharma News
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
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Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.
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Supplier News
The company has launched new services for mammalian cell bank manufacturing under GMP conditions.
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Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
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Regulatory News
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
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FEATURED TOPICS |
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PROCESS DEVELOPMENT
Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond "whatever works" to meet growing demand.
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QUALITY
Too narrow a focus on regulatory compliance may prevent organizations from embracing–and profiting from–quality and operational excellence.
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MANUFACTURING
Despite the growing popularity of single-use technologies in biomanufacturing, there are still instances where stainless steel is the better option.
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UPCOMING WEBCASTS
From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
Monday, September 16, 2019 at 9am EDT | 2pm BST | 3pm CEST
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Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management
Tuesday, September 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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The Versatility of High Throughput Dynamic Light Scattering in Protein Characterization and Formulation Development
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Native MS for Aggregate and Charge Variant Analysis of Biotherapeutics
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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September 3–4, 2019
September 16–18, 2019
September 18–19, 2019
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The editors examine the technology, practices, and regulatory approval questions facing
companies employing single-use technologies for commercial manufacturing.
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