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Article Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO. By Jim Miller While industry participants and observers talk about the “CMO industry,” they know that …

Article Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing. By Bruce Lehr, Delia Lyons Cell-culture technology for biopharmaceutical manufact…

Article Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict. By Randi Hernandez Demand for any given new product is typically only known after significant investments h…

Article Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design. By Peter Genest, John Joseph The benefits of adopting single-use technologies in the production of biopharmaceuticals…

Article Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. By Cynthia A. Challener Vaccine development is a complicated process that can take many yea…

Article Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients. By Jill Wechsler FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …

Article CMOs Continue to Improve Overall Biomanufacturing Performance
Better process development is creating industry benchmarks for bioprocessing. By Eric Langer Biomanufacturing efficiency is on everyone’s minds, being the single most important area of focus…

Article Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …

Article Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems. By Weibing Ding, PhD Single-use technology has been around for approximately two decades if …

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

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