Epidemiological data indicates that over 3 million children under age 5 are hospitalized with respiratory syncytial virus (RSV)-related infections annually, resulting in more than 200,000 deaths. As there remains no licensed vaccine product, disease due to RSV infection remains an unmet medical need. In vitro and in vivo models for RSV vaccine development provide a critical component in development of anti-RSV antibodies, small molecules, and vaccines.
Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters, and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.
The COVID-19 outbreak reveals important lessons on supply chain integrity. While events such as this are impossible to completely prepare for, safeguards can reduce timelines and shorten supply impacts.
A biotech exploring novel therapeutics for neuroscience indications developed a promising new chemical entity to treat a severe pediatric genetic disease. Softgel technology expedited its Phase 2/3 clinical trial.
How one firm improved yield of monoclonal antibody (mAb) product from bulk harvest 1.8 fold by simplifying the downstream process and eliminating the use of resins that resulted in declining yields with short life cycles.