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Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015 By Jill Wechsler Pharmaceutical Technology Volume 39, Issue 4 To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…

Article Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015 By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell BioPharm International Volume 3, Issue 28 In the past two decades, Protein A affinity chromatography ha…

Article Vaccine Development and Production Challenges Manufacturers
Mar 01, 2015 By Jill Wechsler BioPharm International Volume 3, Issue 28 Vaccines are front-page news these days. Researchers are advancing new vaccines for Ebola and other devastating di…

Article Fermentation for the Future
Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development. Jan 01, 2015 By Cynthia Challener, PhD Microorganisms—bacteria and yeast—have b…

Article Technologies and Practices Must Evolve to Meet Demand
Jan 01, 2015  By Rita Peters Through Dec. 3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule …

Article Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain. Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…

Article Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing. By: Randi Hernandez Whil…

Article A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implementi…

Article A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…

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