This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 will present the current state and opportunity for improvement using innovative technology. Part 2 will further discuss some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 will present the impact of technology changes.
Using new approaches to process development and associated equipment, engineering and business models to increase efficiency and reduce costs.
Why understanding both the product and every step of the process is crucial in cell and gene therapy production.
Emerging and virtual biopharmaceutical company’s ask themselves whether to outsource production to a contract manufacturing organization (CMO) or purchase equipment for in-house manufacturing.
Most issues in pediatric drug development arise from the fact that drugs are traditionally developed for adults and not children. Dr. Meyers shares the hurdles and improvements in pediatric drug development.
The transient overheat in empty autoclave chambers is a phenomenon that frequently occurs during validation studies. This article investigates the main causes and methods to prevent it or to cope with it.
Analytical laboratories have to provide sound results in a short time. Speed and reproducibility play a significant role here. Modern automation technology saves time, increases quality and reduces costs for the transport and distribution of samples. Ready-to-install subsystems from Festo are opening up new possibilities for efficient processes in laboratory automation.
The liquid filling space has undergone an evolution in the last quarter century. Just 25 years ago, pharmaceutical companies had engineering resources at their disposal to help put together filling lines. Equipment manufacturers were only contacted when the companies needed a filler, capper, or labeler.
In the American South, below the old Mason-Dixon Line, you can walk down some house-lined streets in summer and see tidy plantings of tobacco growing in the front yards. Tobacco barns, built for drying, not storing, are as common down there as hay barns in Wisconsin.
Bharat Biotech pledged to sell Rotovac for the rotavirus for $1 a dose to compete with GSK and Merck, if they make it cheaper can they make it safer?
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