quanticate
There are approximately 7,000 distinct rare diseases affecting 350 million people worldwide, approximately 80 percent of which are caused by faulty genes. The US Food and Drug Administration (FDA) has more than 700 active Investigational New Drug Applications (INDs) for gene and cell therapies and in 2017, the FDA approved two cell-based gene therapies and it is anticipated that gene therapy will become a mainstay treatment for many rare diseases.
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Cell culture is the unsung workhorse of biopharmaceutical drug development, yet it is so often the essential backbone of discovery projects. The growth of cells in laboratory settings constitutes a wide assortment of factors for their appropriate growth, with environmental conditions raking at the top of the list of importance. Reliable incubator technology is critical to yielding the high-quality results investigators are constantly seeking. Moreover, with respect to GMP, incubator technology must include algorithmic control systems and safeguards designed to protect the cell culture or cell-expressed product, particularly when associated with direct human applications such as cell-derived biologics and whole-cell therapies.
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Tuberculosis (TB) is a leading global infectious disease killer, second only to COVID-191. It is an airborne disease caused by Mycobacterium tuberculosis bacteria and is responsible for infecting an estimated 10.6 million and killing 1.6 million people in 2021 alone1.
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Edupliance
Biological, chemical and physical contaminants continue to play a significant role in causing human illness and death. While most food supply companies are becoming slowly aware of the breadth of system responsibilities they must assume in terms of preventing food safety problems, many are ineffective due to their lack of how contaminants flow through the supply chain and how to establish procedures to stop such flows from entering or exiting their own doors.
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