CAMBRIDGE, Mass. and SOMERSET, N.J., July 29, 2020 (GLOBE NEWSWIRE) — Editas Medicine, Inc. (Nasdaq: EDIT), 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, today 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.
Notes for Editors
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. For more information, visit biologics.catalent.com/cell-gene-therapy/
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. For more information, visit www.catalent.com
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About Editas Medicine
As a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit www.editasmedicine.com.
Editas Medicine’s Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials and clinical development of the Company’s product candidates; availability and timing of results from pre-clinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.0