Explore the latest trends in pharmaceutical manufacturing for cell and gene therapy, key investments, innovations, and facility expansions shaping the pharma.
Cell and gene therapies represent an emerging frontier in bio/pharmaceutical development, offering significant potential for treating complex diseases. While still a niche market, it is attracting substantial investment from major bio/pharmaceutical companies, CDMOs/CMOs, and smaller entities. This article highlights key players expanding their manufacturing capacities, partnerships, and innovations driving the industry forward in 2024.
Big Pharma’s Play in Cell and Gene Therapies
Large pharmaceutical companies have adopted several strategies to boost their cell and gene therapy capabilities. These include both organic growth and partnerships with CDMOs/CMOs, as well as acquisitions of smaller firms with specialized manufacturing capabilities.
Bristol-Myers Squibb and Gilead Sciences
In April 2024, Bristol Myers Squibb (BMS) and Cellares, a CDMO based in South San Francisco, signed a worldwide capacity reservation and supply agreement valued at $380 million. The partnership focuses on manufacturing BMS’ CAR-T cell therapies using Cellares’ Cell Shuttle, an automated cell-therapy manufacturing platform.
- Cellares will provide multiple systems for BMS’ exclusive use across facilities in the US, EU, and Japan.
- The deal expands an existing collaboration between the two, as BMS has invested in Cellares’ technology since August 2023.
Cellares is also working with Kite, a division of Gilead Sciences, which will evaluate the Cell Shuttle platform. In June 2024, Kite began a proof-of-concept study to assess the viability of the technology for future manufacturing.
Cellares secured $255 million in funding to build an 118,000-square-foot facility in Bridgewater, New Jersey, capable of producing 40,000 cell-therapy batches annually. The facility is expected to be cGMP-ready by late 2024.
AstraZeneca
AstraZeneca announced a $300-million investment in February 2024 for a new cell-therapy manufacturing facility in Rockville, Maryland, aimed at T-cell therapies. The Rockville site joins AstraZeneca’s global network of nearly 30 sites across 16 countries, supporting its cell and gene therapy ambitions.
In May 2024, AstraZeneca completed an $840-million investment in Cellectis, leveraging its gene-editing technology to co-develop up to 10 cell- and gene-therapy products in oncology, immunology, and rare diseases.
Further cementing its presence in the field, AstraZeneca acquired Gracell Biotechnologies in February 2024 for $1.2 billion. Gracell specializes in CAR-T therapies for hematologic malignancies and autoimmune diseases, notably through its FasTCART and TruUCART manufacturing platforms.
AbbVie
In January 2024, AbbVie entered into a collaboration with Umoja Biopharma to develop CAR-T cell therapies using Umoja’s VivoVec platform, in a deal valued at up to $1.44 billion. VivoVec enables in-vivo CAR-T production, bypassing many of the traditional challenges of CAR-T therapy, such as cell extraction and external modification.
CDMOs Expand Cell- and Gene-Therapy Manufacturing
Fujifilm Diosynth Biotechnologies
Fujifilm Diosynth is expanding its Thousand Oaks, California facility, with a new development lab and two cleanrooms for cell and gene therapy production, scheduled to be operational by early 2025.
Thermo Fisher Scientific
Thermo Fisher expanded its cell-therapy network with a new 44,000-square-foot facility in San Francisco near the UCSF Medical Center. The facility provides clinical and commercial manufacturing services for advanced therapies derived from patient or donor cells. The company also expanded its plasmid manufacturing capabilities at its Carlsbad, California facility in 2023.
Siegfried
In 2023, Siegfried acquired a 95% stake in Dinamiqs, a Swiss biotech specializing in viral vectors, expanding Siegfried’s footprint in cell and gene therapy manufacturing. A GMP facility is expected to be operational by 2025.
Seqens
In late 2023, Seqens entered the cell and gene therapy space through the acquisition of CELLforCURE from Novartis, gaining control of one of the first large-scale cell therapy production sites in Europe, which was established in 2013.
Emerging CDMOs and Smaller Bio/Pharma Companies
Bionova Scientific
Bionova Scientific, a CDMO specializing in biologics, announced plans to expand into plasmid DNA (pDNA) production with a new development and manufacturing facility in Texas, set to become operational in early 2025. This facility will support pDNA development and offer GMP manufacturing capabilities later in 2025.
Genezen
Genezen, a CDMO based in Indianapolis, acquired a gene-therapy manufacturing facility from uniQure for $25 million in July 2024. The new facility will enhance Genezen’s existing capabilities, allowing it to support more advanced gene-therapy manufacturing.
ProBio
ProBio, a New Jersey-based CDMO, expanded its plasmid DNA and viral vector capabilities with the opening of a 128,000-square-foot facility in June 2024. The facility supports tech transfer and GMP production for both clinical and commercial plasmid DNA and viral vector-based therapies.
Kincell Bio
In April 2024, Kincell Bio formed a strategic partnership with Imugene, acquiring a 32,800-square-foot cGMP manufacturing facility in North Carolina. The facility will support Imugene’s growing pipeline of CAR-T therapies.
The cell and gene therapy space continues to see substantial growth, with major investments in manufacturing capabilities from both large pharmaceutical companies and specialized CDMOs. As these therapies move toward commercialization, the demand for robust manufacturing platforms will only intensify, setting the stage for continued innovation and expansion in the field. With ongoing collaborations, facility expansions, and new technological platforms, the bio/pharma sector is poised for a transformative shift in how advanced therapies are produced and delivered.
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
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