Published: August 2023
These cell therapy companies are leading the cell therapy contract manufacturing industry in terms of manufacturing capacity and expertise. We analyzed more than 150 contract manufacturing organizations (including industry and academic players) that have the required capabilities to offer cell therapy manufacturing across different scales of operation. Of these, discover the 5 leading contract manufacturers and their capabilities in this industry.
Over the years, technological advancements in the healthcare segments have revolutionized the way medicine is practiced. One such advancement made in 1800s entailed the exploration of cell therapies as viable treatment options. Cell therapies are predicated on the fact that cells from a patient’s own body (autologous cell therapy), or those from a healthy donor (allogeneic cell therapy), upon transplantation to the patient can be either be genetically modified to combat the onset or progression of diseases, such as cancer, or their regenerative potential can be used for repairing or regenerating diseased tissues. The initial practice of cell therapy in the 19th century was only limited to studying the potential of this treatment modality in animals. However, with technological and scientific evolution, cell therapies have been developed as viable treatment options for various life threatening diseases, which help combat the concerns associated with cytotoxicity caused by conventional chemotherapies.
The growing demand for cell therapies as therapeutic modalities requires specialized production techniques and facility designs. Further, owing to the fragile nature of living cells and the need for stringent quality control measures, cell therapies require intricate manufacturing processes, specialized manufacturing facilities, including cleanrooms and bioreactors, and cGMP manufacturing standards. As a result, drug developers are increasingly relying on contract manufacturers to leverage their capabilities and yield cost savings opportunities. In this context, a number of cell therapy manufacturing companies, each having varying strengths and capabilities, have emerged in the pharmaceutical sector.
Roots Analysis has conducted an exhaustive study on Cell Therapy Manufacturing Market featuring the current market landscape and future opportunity for the contract manufacturing organizations involved in cell therapy manufacturing, over a span of 10 years.
In order to ensure a continued success rate of these cell therapies, there are several ongoing efforts to address the complexities related to their development and manufacturing. The aforementioned efforts are focused on improving cell handling and processing equipment, ancillary materials, cell counting technologies, and addressing existing logistical concerns. Further, it is becoming increasingly important for cell therapy developers and manufacturers to invest in flexible and automated technologies, in order to combat the challenges associated human intervention in the manufacturing process of these cell therapy candidates. As such, the contract manufacturers are supporting the cell therapy market by upgrading their capabilities.
The top five cell therapy CDMO offering manufacturing services to the cell therapy companies are listed below (in alphabetical order):
Table 1: List of Top 5 Cell Therapy CDMO
|S. No.||Cell Therapy Manufacturer||Year of Establishment||Number of Employees||Location of Headquarters|
|1||AGC Biologics||2001||1,000-5,000||Washington, US|
|2||Charles River Laboratories||1947||10,001+||Massachusetts, US|
|3||FUJIFILM Cellular Dynamics||2004||51-200||Wisconsin, US|
|4||Thermo Fisher Scientific||2006||10,001+||Massachusetts, US|
|5||Wuxi AppTec||2000||10,001+||Shanghai, China|
Interested in exploring all 150+ Cell Therapy CDMO and 90+ In-House Manufacturers?
This article highlights the 5 leading contract manufacturing organizations to watch out for in this industry. These companies were chosen based on their cell therapy manufacturing associated service portfolio (R&D, cell culture development, cell banking, manufacturing, documentation, testing and analysis, packaging, supply chain management and regulatory support) strength. It is essential to note that the selection of top players can differ substantially according to the defined criteria.
AGC Biologics is a leading cell therapy contract development and manufacturing organization (CDMO). The company claims to have necessary capabilities and expertise in research and development, process development and current good manufacturing practice (cGMP) regulated manufacturing of cellular therapies. It is also focused on the development of protein-based antibodies, enzymes and other pharmaceutical ingredients using mammalian and microbial production systems. In August 2023, AGC Biologics announced expansion at its Milan, Italy facility. The expansion included installation of several single use bioreactors for production of viral vectors, which are an important starting material for cell therapies. This facility was acquired by AGC Biologics in 2020 from MolMed. This expansion came after nearly one year of the company’s expansion at its Colorado, US site. AGC Biologics acquired the Colorado facility from Novartis in August 2021 and announced expansion of viral vector manufacturing at the site in May 2022. As per the financial targets and key strategies published by AGC Group, the parent company had planned to invest in the growth of its life science business in line with the market growth.
AGC Biologics offers manufacturing services for the following cell types:
Cell Therapy Manufacturing Facilities: Milan (Italy), Bresco (Italy) and Colorado (US)
Additional Services offered for Cell Therapies: Cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage, and protein expression.
In August 2022, the company announced a partnership with RoosterBio in order to create a solution for the production, development, and manufacturing of human mesenchymal stromal cells and exosome therapeutics. Additionally, in May 2023, the company launched two viral vector platforms with the aim to support manufacturing of cell and gene therapies at clinical and commercial scales of development. Further information related to services offered, scales of operation and regulatory certifications and accreditations is available in the full report.
Charles River Laboratories (CRL) is a contract development and manufacturing organization providing drug-discovery and development services, conducting safety and efficacy studies, providing clinical support, and manufacturing services across a wide range of therapeutic areas. Charles River Laboratories’ journey in the cell and gene therapy industry began with acquisitions in 2021. The first acquisition came in February 2021 with the company taking over Cognate BioServices, a cell and gene therapy CDMO, for approximately USD 875 million in cash. This was followed by the acquisition of Vigene Biosciences, a viral vector and plasmid DNA manufacturer, in May 2021 for more than USD 292 million in cash. As such, CRL has put in more than USD 1 billion to expand its cell and gene therapy manufacturing capabilities.
Charles River Laboratories offers manufacturing services for the following cell types:
Cell Therapy Manufacturing Facilities: Tennessee (US) and Maryland (US)
Additional Services offered for Cell Therapies: GMP manufacturing, tolerability and viability studies, biodistribution and tumorgenicity studies, pathological evaluations, and toxicity evaluations.
In 2022, CRL has invested in organic expansions. This includes the opening of a High-Quality Plasmid Center of Excellence at Alderley Park, that aims to support the development of cell and gene therapies in June 2022.
In November 2022, Charles River Laboratories expanded its capacity for clinical and commercial cell therapy development and manufacturing through the addition of nine processing suits and 16 cleanrooms at its facility in Tennessee, US. Further information related to services offered, scales of operation and regulatory certifications and accreditations is available in the full report.
FUJIFILM offers a wide range of services in various domains, such as healthcare, graphic systems, highly functional materials, optical devices, digital imaging, and document products. The company provides contract manufacturing services for cell therapy products through its subsidiaries in the US (FUJIFILM Cellular Dynamics) and Japan (Japan Tissue Engineering) by using its innovative technologies for industrial manufacturing of human cells that are derived from induced pluripotent stem cells. The firm claims to manufacture quality products that showcase required purity levels and are reproducible, in virtually unlimited quantities. The manufacturing system of the company states to be capable of producing > 10 billion iPSCs per batch.
The company opened its first GMP compliant facility for manufacturing of induced pluripotent stem cells (iPSCs) for clinical trials at Science Drive, Wisconsin in March 2019. In November 2022, it announced its plans to open another 140,000 square foot facility at Excelsior Drive, Wisconsin. The planned facility will be GMP compliant with cleanrooms for commercial manufacturing.2
FUJIFILM Cellular Dynamics offers manufacturing services for the following cell types:
Cell Therapy Manufacturing Facility: Wisconsin (US)
Additional Services offered for Cell Therapies: GMP manufacturing, cryo-preservation, cell banking, quality control and testing, and distribution.
In January 2023, the company entered into an agreement with Novo Nordisk for the utilization of Fujifilm Cellular Dynamic’s iPSC platform for the development and commercialization of cell therapies targeting chronic diseases. Further information related to services offered, scales of operation and regulatory certifications and accreditations is available in the full report.
Thermo Fisher Scientific is a US-based company formed from by the merger of Thermo Electron and Fisher Scientific in 2006. The company claims to offer cell therapy solutions across all stages of development, ranging from early discovery to cell therapy commercialization. The cell therapy manufacturing services are provided through Patheon Pharma Services.
In March 2023, Thermo Fisher Scientific expanded its cell therapy manufacturing portfolio with the addition of a new facility adjoining the UCSF Medical Center’s Mission Bay campus. This new facility offers both clinical and commercial scale cGMP cell therapy manufacturing services. However, in April 2023, the company announced its plans to shut down operations at its Princeton, New Jersey facility citing changing volume demands. This facility was the first manufacturing site serving the company’s cell therapy customers when it opened in 2020.
Thermo Fisher Scientific offers manufacturing services for the following cell types:
Cell Therapy Manufacturing Facilities: California (US), Stevenage (UK)
Additional Service offered for Cell Therapies: GMP manufacturing, cryo-preservation, cell banking, quality control and testing and, distribution.
In March 2023, the company entered into an agreement with Arsenal Biosciences to support the development and manufacturing of autologous T-cell therapies through clinical stages of development. In February 2023, Thermo Fisher Scientific announced the launch of a Cell Therapy Collaboartion Centre in Singapore to offer services for cell therapy development from clinical research to commercial manufacturing. Further information related to services offered, scales of operation and regulatory certifications and accreditations is available in the full report.
WuXi AppTec is one of the most prominent contract manufacturing organizations (CMOs) that offers services to the pharmaceutical and healthcare industry. WuXi Advanced Therapies, a business unit of WuXi AppTec, is a contract testing, development and manufacturing organization (CTDMO) focused on accelerating the testing, development, manufacturing, and commercialization of cell and gene therapies. The company has three major global operating segments including small molecule R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, and medical device testing. The firm aims to provide the most advanced technology platforms to various pharmaceutical industries in order to develop and accelerate the launch of new and innovative healthcare products. Headquartered in Philadelphia, the company opened its first manufacturing facility for cell and gene therapies to serve the Asia-Pacific market in Shanghai, China in October 2021. In April 2022, Wuxi Apptec announced an agreement with the A*STAR’s Bioprocessing Technology Institute, a Singapore based research group, for the purpose of advancing its cell and gene therapy manufacturing operations in Asia-Pacific region.
WuXi AppTec offers manufacturing services for the following cell types:
Cell Therapy Manufacturing Facilities: Philadelphia (Pennsylvania), Shanghai (China) and Singapore
Additional Services offered for Cell Therapies: GMP manufacturing, analytical development, process development, viral vector production platform, and regulatory support.
In June 2023, WuXi Advanced Therapies announced a collaboration with T-MAXIUM Biotech, a China based clinical-stage cell therapy company. Under the terms of the agreement, WuXi ATU will testing, development, manufacturing and IND filing services for MT-027, an allogeneic CAR T cell therapy targeting B7-H3. Further information related to services offered, scales of operation and regulatory certifications and accreditations is available in the full report.
The above presentation features five promising service providers selected from a pool of over 150 contract manufacturing organizations that we have compiled. If you are interested, you can download the Sample Report on “Cell Therapy Manufacturing Market” by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at email@example.com.
Dhriti is a Senior Business Analyst, working as an integral part of the Roots Analysis team since 2021. Passionate about the intersection of science and industry, she holds a Bachelor’s degree in biotechnology from a renowned university. Possessing keen interest in the pharma domain, Dhriti initiated her professional journey with a strong academic foundation. Her passion to learn more about the emerging trends and technological advancements has enabled her to provide comprehensive insights through syndicate reports and consulting assignments. The unique blend of scientific knowledge and business acumen has enabled her to provide insightful analysis in the ever-evolving life-sciences domain. Till date, she has earnestly contributed to over 6 in-depth market research reports on trending topics, ranging from non-hormonal therapies for women health, oligonucleotide synthesis, RNAi therapeutics and technologies, cell therapy manufacturing to next deep learning in drug discovery and diagnostics.
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