To date, Catalent has undertaken manufacturing and related services for Editas Medicine at its gene therapy manufacturing facility in Baltimore, MD. Through the extended partnership, Catalent will provide further services to include development and manufacturing of Editas Medicine’s complex cell and gene medicines from its best-in-class facilities in Harmans/BWI, MD, and Houston, TX. In addition, Catalent will play an integral part in delivering these vital therapies from its Philadelphia facility to clinical trial sites for administration to patients. Catalent’s integrated support will range from supplying critical raw materials, viral vectors, and engineered cell medicine production to storage and distribution of finished product for clinical trials.
“As a key part of our in vivo medicines and engineered cell medicines manufacturing strategy, we are pleased to partner with Catalent to manufacture and secure our clinical supply—the latter being a critical component to ensure we can deliver the transformative medicines we are developing to clinical trial sites and patients participating in the study.”
Julien Meissonnier, chief scientific officer, Catalent, said, “Catalent is proud to collaborate with Editas in its efforts to bring new targeted and durable CRISPR-based medicines to patients. Together, we have established a unique, integrated model enabling access to Catalent’s advanced cell and gene therapy technologies and clinical supply services. We value early partnerships with innovators and pioneers such as Editas, to enable the emergence of new therapeutic modalities by developing reliable, scalable manufacturing processes, and accelerating access to first-in-human studies.”
Catalent’s cell and gene therapy facilities include the new 32,000 square feet cell therapy clinical facility near Houston, which is expected to be fully validated in 2020, as well as a clinical facility in Gosselies, Belgium, with a dedicated commercial-scale plant currently under construction and expected to be fully commissioned in 2021. The state-of-the-art Harmans/BWI commercial gene therapy manufacturing facility is equipped with single-use technology and includes over 200,000 square feet of late-stage clinical and commercial-stage gene therapy production capabilities. The Harmans/BWI facility is one of Catalent’s five clinical through commercial scale gene therapy facilities in Maryland.