Removing Roadblocks for Cell & Gene Therapies

Cell and gene therapies (CGTs) are a fast-advancing, emerging area of drug development that faces unique challenges when it comes to manufacturing and compliance. To ensure that CGT developers adhere to existing guidelines or can modify their processes without infringing regulations, it is essential that they have in place reliable, effective quality management systems. Designing and implementing such systems comes with special considerations that take into account the resource related, supply chain, scalability, and other limitations CGT companies typically encounter.