Search results for " Center of Excellence"

Article Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work. Life-sciences companies face more pressure than ever to reduce costs and increase eff…

Article A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science. Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…

Article Virus-like Particles as Therapeutic Moieties of the Future
Rathore*, PhD, is professor in the Department of Chemical Engineering and coordinator, DBT Center of Excellence for Biopharmaceutical Technology, all at the Indian Institute of Technology, Delhi, Hauz…

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 Taking a “Development-by-Design” Approach to Cell Therapies
Cytiva is also evaluating Wave and other systems and set up a center of excellence in Wales recently. In other equipment areas, Pall Corp. has been partnering with CMDG LLC on cord blood processin…

Article Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends. With the dawn of the 2…

Article Reimagining Affordable Biosimilars
Rathore, PhD* is professor in the Department of Chemical Engineering and coordinator, DBT Center of Excellence for Biopharmaceutical Technology, at the Indian Institute of Technology, Delhi, Hauz Khas…

Article Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Acknowledgements This work was funded by the Center of Excellence for Biopharmaceutical Technology grant under Department of Biotechnology, Government of India. References 1. R. Karlsson, …

Article Best Practices for Data Integrity
Best Practices for Data Integrity Optimize practices and meet requirements using electronic data integrity systems. By Jennifer Markarian Maintainin…

Article Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities. By Feliza Mirasol Ensuring viral clearance (i.e., removal) in downstream purification has becom…

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