Cellular and gene therapy is a rapidly growing area of drug discovery, evidenced by the growing number of products in various stages of development. As of late 2025, the U.S. FDA had approved nearly 50 cell and gene products, up considerably from the end of 2023 when there was a total of 34 approved cellular and gene therapy products. These emerging classes of biologics offer the potential to effectively treat or mitigate previously untreatable conditions, ranging from various cancers to genetic conditions, blood disorders, and other difficult-to-treat conditions.
Creating cell-based therapies, including cellular immunotherapies, cancer vaccines, and other types of autologous and allogeneic cells for therapeutic indications, is a complex process. The emergence of advanced tools and techniques has helped address some of the challenges and more and more cell therapies are advancing through clinical trials. In this section of the content hub, we will cover cell therapy development processes from discovery to manufacturing and include tips for workflow optimization. Read more
Gene therapy works by replacing, inactivating or introducing genes into cells for therapeutic purposes. Since the term was coined over 30 years ago, the field has advanced in fits and starts and today there are just a few approved gene therapy products. Increased knowledge and novel technologies are starting to chip away at some of the obstacles preventing greater gene therapy success. This section of the content hub will cover the gene therapy development processes from discovery to manufacturing and include tips for workflow optimization. Read more
In cell-based gene therapy, cells are genetically altered for therapeutic benefits. This category, which includes CAR T cell therapy, has its own set of challenges. This section of the content hub will discuss technologies and initiatives that show promise to help overcome some of the limitations including ineffectiveness with solid tumors and severe toxicities. Read more