03.06.24 -- A New Approach To Allogeneic Cell Therapy Process Development

Novel analytical technologies such as droplet digital PCR (ddPCR) provide a more rapid and robust approach to nucleic acid quantification for therapeutic development that better aligns with the industry need for better sensitivity, accuracy, and precision. This relatively new form of PCR offers distinct advantages for DNA and RNA quantification.

Recent years have proved challenging for the viral gene therapy community. Drug developers report difficulties securing adequate funding for a full program and the need to adapt to more conservative funding packages. As a result, sponsors may opt to outsource construct design through Phase 1 to experienced CDMOs.

As developers work to scale mesenchymal stem cells (MSCs) and MSC-EVs (extracellular vesicles), the value of identifying a CDMO with the incumbent expertise, capacity, and supporting partnerships to fast-track these crucial modalities is key to advancing their therapeutic potential and regulatory acceptance.

The journey toward preparing a GMP facility for an allogeneic cell therapy product’s commercialization began with the construction of a cell therapy facility. Review the challenges, triumphs, and lessons learned that have shaped an evolution from facility construction to a fully operational, patient-focused CDMO.

Allogeneic cell therapies have the potential to greatly improve the economies of scale associated with cell therapy production when compared to autologous cell therapies. By working to standardize the process steps and tools, operators can enable greater speed and reduce the potential for error during later phases of development and scale-up.