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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 Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing? By Rajeev J. Ram In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…

Article Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The system consists of two bench-top chromatography instruments connected to a central unit with eight disposable filtration devices used for loading and filtering the cell cultures. The staggered par…

Article Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling. By Susan Haigney Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…

Article Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International Humans represent the greatest risk for microbial contamination in an aseptic process. Aseptic processing has garnered some increased scrutiny…

Article Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015 By Agnes Shanley BioPharm International eBooks Volume 28, Issue 13 Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…

Article Quality Systems Key to Lifecycle Drug Management
Field inspection is not connected to knowledge gained from product review, and there can be a significant disconnect between clinical batch data and commercial production. CDER’s new Office of Pharm…

Article A Bright Future for the Plasma Fractionation Industry
Over the years, albumin has been connected with several controversies and even medical research fraud scandals. Now the future for albumin looks brighter, according to More, and not only in China. …

Article Continuous Chromatography: Trends, Definitions and Approaches
Obviously, prevention of bioreactor contamination is of paramount importance if the reactor is operated in perfusion mode and is connected to a continuous chromatography system, but this can be realiz…

Article Challenges and Trends in Biopharma Facility Design
…cture, but now modular stick built or container built becomes obsolete, since these structures, once connected, are just as inflexible as the old traditional structures (2, 3). Most of these systems …

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