Biopharma Giants Make Big Manufacturing Commitments

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Two U.S. biopharma companies have announced expansions and commitments to increase manufacturing for therapeutics. 

Massachusetts-based Intellia Therapeutics announced that it has entered a lease agreement to develop a 140,000 square-foot manufacturing facility in Waltham, MA. The manufacturing facility exists primarily to support the manufacturing of key components for its CRISPR-based investigational therapies in a Good Manufacturing Practice (GMP) compliant facility. The aim of the new facility is to support preclinical development through commercial supply and provide capacity and capabilities in support of the company’s expanding pipeline and commercial readiness. 

The customized facility is expected to be operational in 2024. Intellia leases 65,000 square feet of office and lab space, and when it outgrew this space, an additional 60,000 square feet of space was leased in two other Cambridge facilities. Although the company has not stated if its newfound growth will lead to the creation of more jobs, the company employed more than 300 people as of 2021, and it has been listed as one of the top 12 biotech companies hiring in 2022 by BioSpace. 

Intellia has recently teamed up with ONK Therapeutics to conduct natural killer cell-based cancer immunotherapy research. ONK Therapeutics will use Intellia’s proprietary gene-editing platform and lipid nanoparticle-based delivery technologies to develop up to five allogeneic natural killer cell therapies.

In exchange, Intellia stands to receive up to $184 million per product and royalties up to mid-single digits. Intellia also acquired Rewrite Therapeutics and its DNA writing technology after the company showed innovative promise with the introduction of two novel CRISPR therapies. The acquisition leaves Intellia poised to usher in a new wave of CRISPR therapy for patients. 

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Moderna and Thermo Fisher Scientific have entered into a long-term agreement for the manufacturing of its COVID-19 vaccine, as well as other experimental therapeutics utilizing mRNA technology. The two companies have partnered over the past several years to support the development of pipeline programs within both clinical research and contract manufacturing services. This includes the quick scale-up of aseptic fill-finish services and packaging of Moderna's COVID-19 vaccine. In June of 2021, Moderna began operating at Thermo Fisher’s commercial manufacturing site in North Carolina to fill, finish and package millions of doses of the vaccine.

As part of the 15-year strategic collaboration agreement, Thermo Fisher will provide dedicated capacity for a broad range of aseptic fill-finish services such as lyophilized and liquid filling. It will also provide inspection, labeling and final packaging services. Heads of each company stated that the partnership will provide strategic manufacturing capabilities to produce a robust mRNA platform and pipeline.  

In addition to partnering with Thermo Fisher to expand manufacturing capabilities, Moderna also recently partnered with Adium Pharma, a leading private Latin American pharmaceutical company. With this alliahce, the commercialization of Moderna’s COVID-19 vaccine will spring forth in 18 countries in Latin America, including Brazil, Mexico, Colombia and Argentina, filling the need for a global commercial strategy in the fight against COVID-19. Moderna already has a commercial presence in 11 countries worldwide and has announced plans to increase its reach to ten additional markets in Asia and Europe in 2022.  

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