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.
As you work to establish a reproducible and successful manufacturing process in the early phases of your AAV therapy development, partnering with a CDMO that offers candidate screening and feasibility studies can help de-risk potential manufacturing challenges and evaluate the pros and cons of different production strategies.
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 improved sensitivity, accuracy, and precision. This relatively new form of PCR offers distinct advantages for DNA and RNA quantification.
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.
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 a CDMO Partner for Life™, our goal is to advance your cell therapies from lab to commercial scale, leveraging our cell and gene therapy expertise and global cGMP network.
