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Newsletter | April 15, 2021 By Crystal M. Booth, PSC Biotech Trending environmental monitoring (EM) data are a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, I look first at the regulations and guidelines around EM.
By Julia Kosan, Ph.D candidate, Friedrich Alexander University, Erlangen, Germany Vaccination prevents millions of deaths from infectious diseases per year; however, there are still millions of people who die from these diseases due to weak thermostability demanding cold chains, long-term stability issues and distribution challenges. All these limitations can be overcome by creating a dry product through lyophilization.
Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials. However, there are obstacles to the development of placebo formulations regarding both intended uses.
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