Drug modalities have grown increasingly complex over time; relatively simple small molecules were followed by recombinant proteins, monoclonal antibodies and now cell and gene therapies. As the complexity of the therapeutic entity itself increases, so do manufacturing and testing processes. Consider just some of the challenges presented by cell and gene therapy manufacturing: undefined raw materials, process variability due to sensitive biological systems, interdependency of process and product, unique contamination control requirements and increased regulatory scrutiny.
At the core of cell and gene therapies is the viral vector used to deliver the gene of interest to the target tissue. Because vectors are an integral part of these therapies, extensive safety and characterization testing is required for their safe and efficient production – which can present yet another challenge during development and manufacturing. This white paper explores how safety and characterization testing of viral vector production differs from that of other biologics and how novel analytical approaches are being tailored to these advanced therapeutics.