Manufacturing a Cure for the World’s Most Devastating Diseases
At the rate that innovation is coming to the cell and gene therapy space, this is undoubtedly an exciting time for the industry to extend its reach to patients. And, as the technologies become more advanced and transform, regulations are going to evolve and adapt in order to address the biggest risks to the patient. As you look to implement GxP approaches to CGT manufacturing, it's important to understand current regulatory standards for pharmaceuticals and biotechnology, as well as how they translate to novel therapeutics. From regulatory guidance to infrastructure to training, there are a myriad of challenges for cell and gene therapy (CGT) innovators. Download this white paper to learn more about how to navigate these hurdles in bringing your treatment to market.