Cell & Gene Therapies: CROs and CMOs Bridge the Gap from Innovation to Approval

Cell and gene therapy (CGT) is a rapidly evolving field producing powerful new treatments for cancers and genetic diseases, with promising developments expanding into autoimmune disease, cardiovascular disease, musculoskeletal disease, and many others as well. The CGT field has generated great interest and hope among researchers, patient groups, and regulators, which has led to huge investments in R&D.

Among the many aspects of CGT that sets it apart from other therapeutic modalities is the pace at which technology transfer is occurring, expanding the sphere of R&D well beyond the pharma/bio sector and blurring the traditional delineations between the sectors that participate in therapeutics development. New discoveries in basic research made in academia are quickly being translated to therapeutics development. In fact, many members of academia are leveraging their discoveries to bridge into pharma/bio, creating a large number of startup companies in the CGT space, and greatly outpacing the crossover for other therapeutic modalities such as small molecule and biologics.

With so many new and inexperienced participants, ample opportunities exist for contract service providers. CROs and CMOs have emerged as key collaborators to move through the long and complicated process of developing CGTs, guiding clients through the various stages of early R&D, clinical testing, methods development, and applying for regulatory approval. CMOs are crucial in the CGT landscape. The manufacture of CGTs is very logistically, technically, and regulatorily complicated, making contract manufacturing an attractive option. Manufacturing in cell and gene therapy must be designed meticulously from the beginning of the process through clinical therapeutic delivery, making process development more difficult compared to most other therapeutics. In many cases, CROs and CMOs have taken outsized roles in CGT, even taking on primary R&D roles on behalf of clients.

Behind the incredible advances in CGT are a plethora of suppliers supporting R&D and manufacturing efforts. To help these suppliers navigate the unusual R&D and manufacturing landscape of CGTs, SDi has released a new Cell & Gene Therapy Technologies and Supplies Report. The report examines the global market for analytical technologies and products used throughout the various stages of CGT development and manufacturing, evaluating 21 technologies grouped into six categories. The goal of this report is to provide demand growth projections by technique, region, and function, while also providing comprehensive views of the competitive landscape for each technology.