Editas Medicine, Inc., a leading genome editing company, and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced that they have entered into a strategic partnership whereby Catalent will provide support for the development, manufacturing, and clinical supply of Editas Medicine’s current and future portfolio of in vivo CRISPR medicines and engineered cell medicines.
To date, Catalent has undertaken manufacturing and related services for Editas Medicine at its gene therapy manufacturing facility in Baltimore, Maryland. 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, Maryland, and Houston, Texas. 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.
Harry Gill, Editas Medicine’s Senior Vice President of Operations, commented, “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.”
“Catalent is proud to collaborate with Editas in its efforts to bring new targeted and durable CRISPR-based medicines to patients,” said Julien Meissonnier, Catalent’s Chief Scientific Officer. “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 (3,000 square meter) 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 (19,600 square meters) 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.
Catalent is a global leader in clinical supply services, with comprehensive and flexible solutions for small molecules, biologics, and cell and gene therapies and integrated solutions to accelerate speed to clinic. The Philadelphia facility has recently expanded its cryogenic handling capabilities to meet the growing demand for clinical supply of cell and gene therapy trials. Catalent has nine GMP clinical packaging facilities and over 50 strategically located depots on six continents for global clinical trial support.
About Catalent Cell & Gene Therapy
Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing to position Catalent as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global network of clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. Catalent Cell & Gene Therapy has produced more than 100 cGMP batches across 70+ clinical and commercial programs.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.