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Article Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency. By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore Virus-like…

Article Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
The collaboration addresses the need for risk mitigation plans in cell therapies. On Dec. 3, 2020, Cytiva and 4Tune Engineering, a manufacturing-sciences and technology company, announced that th…

Article Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.  By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani  Drug development is …

Article Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity. On Sept. 13, 2020, Cytiva, announced that it is investing $500 million o…

Article EMA Confirms Standards for COVID-19 Treatment Evaluations
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicine…

Article Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.   By: Pranav Vengsarkar and Nandu Deorkar I…

Article Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com The complexity of biologics and the use of new technologies present challenges for complying with CGMPs. By Lauren Lavelle …

Article Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Biomanufacturing: Demand for Continuous Bioprocessing Increasing But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.   …

Article Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint
Buffer preparation requires extensive footprint and is also resource intensive. In fact, buffer preparation is known to be one of the most resource-intensive activities in biomanufacturing, as large…

Article Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar. By Cynthia A. Challener …

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