Published: September 2023
Owing to the rising demand for biologics and various benefits associated with single use systems, the biopharmaceutical industry is gradually shifting its focus from conventional bioreactors to more advanced disposable bioreactors. We analyzed over 60 Single use Bioreactor manufacturers that have been involved in offering various types of single use bioreactors. In this article, discover seven leading single use bioreactor manufacturers that shine in the competitive landscape of North America.
The modern biopharmaceutical industry, which is poised for significant growth over the coming years, is characterized by several blockbuster therapies (such as Humira®, Rituxan®, Lantus®, Avastin®, Herceptin® and Remicade®) and a robust pipeline of product / therapy candidates. Traditionally, stainless steel bioreactors were the preferred choice for production of biologics; however, over the past couple of decades, biopharmaceutical manufacturing has gradually witnessed a shift towards the use of single use technologies. Apart from low contamination risk and better product yield, single use bioreactor are easy-to-install and have a much smaller footprint, compared to the traditional stainless steel systems. In addition to enabling substantial cost savings (by eliminating the need for additional steps, such as sterilization, cleaning, and maintenance), single use bioreactor are also less demanding of energy and are known to help conserve resources, such as water and CO2. Moreover, the upfront cost of such biomanufacturing solutions is also not very high.
Till date, many biopharmaceutical companies and biologic contract manufacturers have upgraded their manufacturing infrastructure and facilities to include single use systems in their manufacturing line. In addition, there are a number of companies that are now involved in the development and manufacturing of single use bioreactor. Several of these players are now focusing on incorporating a variety of additional features, including provisions for alerts / alarms, built-in system process control sensors, electronic process logs, remote monitoring features, touch screens, and advanced safety provisions, in their proprietary offerings. In fact, single use bioreactor are extensively being used for the production of various vaccines and biopharmaceuticals. The overall single use bioreactor market is anticipated to witness substantial growth, primarily driven by the increasing adoption of such manufacturing solutions among small companies and startups in the coming years. Furthermore, a number of single use bioreactor manufacturers are also supporting the biologics manufacturing market through the supply of bioprocess controllers that allow workflow automation.
Roots Analysis has conducted an exhaustive study on Single Use Bioreactors Market featuring the current market landscape and future opportunity for the technology manufacturers involved in the manufacturing of technologies, over a span of 12 years.
The top seven companies manufacturing single use bioreactor are listed below (in alphabetical order):
1. Celartia
2. Cell Culture Company
3. Cytiva
4. Merck Millipore
5. PBS Biotech
6. Synthecon
7. Thermo Fisher Scientific
Interested in exploring all 60+ Single Use Bioreactor Manufacturers?
This article highlights seven leading single use bioreactor manufacturers in North America to watch out for in 2023. The companies presented in this article were established pre-2011 and offer at least four single use bioreactor. It is essential to note that the selection of top players can differ substantially according to the defined criteria(s).
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Celartia is a biotechnology company, offering services related to research, development, and manufacturing of cell culture products, to cater to the needs of pharmaceutical industry. The company claims to offer a wide range of cell culture systems under the brand name, Petaka, designed to culture different cell types, especially stem cells and tumor cells. Further, the company claims to have cell culture systems that utilize sound engineering techniques and scientific reasoning to transform their knowledge into standardized results. Additionally, the firm provides a robotic cell culture system to ensure automated handling and management of Petaka.
Single Use Bioreactor Product Portfolio
The list of single use bioreactor that are being manufactured by Celartia, along with information on the type of bioreactor is mentioned below:
| Product Name | Type of Bioreactor |
| PetakaG3 LOT (Low Oxygen Transfer) | Diffusion Bioreactor |
| PetakaG3 ET (Easy Transfer) | Stirred Tank Bioreactor |
| PetakaG3 HOT (High Oxygen Transfer) | Stirred Tank Bioreactor |
| PetakaG3 FLAT (For Low Attachment) | Stirred Tank Bioreactor |
| PetakaG3 MATRIX | Stirred Tank Bioreactor |
Recent Developments and Future Outlook
The firm has expanded its global occupancy by entering into emerging / international markets. In January 2020, the company entered into a distribution agreement with Gemini Bioproducts, in order to expand its geographical reach of single use cell culture cassettes in the US. Despite the fact that publicly available information is fairly limited, we anticipate the firm to continue to enter into more such collaborations in the pursuit of increased sales of its bioreactors.
Further information related to Celartia’s financial performance, product portfolio and recent developments is available in the full report.
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Cell Culture Company is a contract development and manufacturing organization (CDMO). The company was incepted as a wholly-owned subsidiary of Biovest International with an aim to offer improved bioreactors and bioservices solutions in 2016. As per the firm’s website, it performs manufacturing operations in accordance with the regulatory guidelines issued by the USFDA, European Medicines Agency (EMA) and United States Department of Agriculture (USDA). Further, it offers R&D scale manufacturing of automated single use hollow fiber perfusion bioreactors. In addition, the company mentions that it has the capability to perform GMP grade manufacturing of recombinant proteins and monoclonal antibodies in order to meet small to mid-scale demands of its customers.
Single Use Bioreactor Product Portfolio
The list of single use bioreactor that are being manufactured by the firm, along with information on the type of bioreactor is mentioned below:
| Product Name | Type of Bioreactor |
| HF-Primer | Hollow Fiber |
| AutovaxID | Hollow Fiber |
| AcuSyst-Maximizer | Hollow Fiber |
| AcuSyst-Xcellerator | Hollow Fiber |
Recent Developments and Future Outlook
The company aims to supply a series of automated single use perfusion bioreactor systems and offer custom mammalian cells and protein manufacturing services. These products are intended to cater to the therapeutic, diagnostic and animal healthcare industries. It is worth highlighting that the firm is committed to provide quality products and contract manufacturing services that meet regulatory guidelines and customer satisfaction. Despite the fact that publicly available information is fairly limited, we anticipate the firm to be on the lookout for additional collaboration / partnership opportunities to expand the reach of its single use bioreactor into global markets in the pursuit of increased sales of its products.
Further information related to Cell Culture Company’s financial performance, product portfolio and recent developments is available in the full report.
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Cytiva, formerly known as GE Healthcare Life Sciences, is a US based company that claims to offer a wide range of technology solutions and services for the manufacturing and delivery of life-changing therapies. It is important to note that the company was acquired by Danaher Life Sciences in April 2020 for USD 21.4 billion. The company’s key customers include firms engaged in biological research and development of innovative vaccines, biologic drugs, and novel cell and gene therapies. In May 2023, the company completed its merger with life science business of Pall Corporation adding to its portfolio the iCELLis single use bioreactor for adherent cells, amongst several other products.1 The firm offers its products / services through 16 manufacturing sites, in more than 40 countries across the globe. Further, the company’s cell culture portfolio encompasses a variety of products, including bioreactors, fermenters, cell culture medium, feeds, and serum, which provide an ideal environment for cell growth and are suitable for applications in research and biomanufacturing.
Single Use Bioreactor Product Portfolio
The list of single use bioreactor that are being manufactured by the firm, along with information on the type of bioreactor is mentioned below:
| Product Name | Type of Bioreactor |
| ReadyToProcess WAVE 25 Rocker | Diffusion Bioreactor |
| Xcellerex XDR-10 Bioreactor System, Single Vessel | Stirred Tank Bioreactor |
| Xcellerex XDR Single Vessel | Stirred Tank Bioreactor |
| Xcellerex XDR-10 Bioreactor System, Multi-Vessel | Stirred Tank Bioreactor |
| Xcellerex XDR Multi Vessel | Stirred Tank Bioreactor |
| Xuri Cell Expansion System W5 | Wave Induced / Rocking Bioreactor |
| Xuri Cell Expansion System W25 | Wave Induced / Rocking Bioreactor |
| iCELLis Nano System | Fixed-Bed Bioreactor |
| iCELLis 500+ System | Fixed-Bed Bioreactor |
| Allegro STR 50 Bioreactor | Stirred Tank Bioreactor |
| Allegro STR 200 Bioreactor | Stirred Tank Bioreactor |
| Allegro STR 500 Bioreactor | Stirred Tank Bioreactor |
| Allegro STR 1000 Bioreactor | Stirred Tank Bioreactor |
| Allegro STR 2000 Bioreactor | Stirred Tank Bioreactor |
Recent Developments and Future Outlook
The company endeavors to provide innovative and quality single use bioreactor to their customers. In April 2023, the company announced the launch of its X-platform bioreactors to simplify upstream biomanufacturing operations of monoclonal antibodies (mAbs) and protein-based drug manufacturing. Further, in 2021, Cytiva and Pall Corporation announced the investment of $1.5 billion to meet growing demand for biotechnology solutions. It is worth highlighting that over $300 million were invested related to single use technologies in order to meet growing demand for biotechnology solutions. Despite the fact that publicly available information is fairly limited, we believe that the company is likely to continue focusing to strengthen its offerings and expand its client base by establishing relationship with other industry / non-industry players engaged in this domain.
Further information related to Cytiva’s financial performance, product portfolio and recent developments is available in the full report.
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Merck Millipore, a subsidiary of Merck, operates as a life sciences division which caters to research, development and manufacturing needs of the biotechnology and pharmaceutical industries. The company has entered into several collaborations related to new scientific and engineering insights and claims to serve as a strategic partner for various clients, in the field of life sciences. Further, the company provides a comprehensive range of products that are intended to cater to the needs of development and production processes. The company’s Mobius single use bioreactors offer flexible assemblies for software, hardware, and single use solutions, utilized for their fed-batch and perfusion applications. In addition, it offers mammalian cell culture and recombinant protein production through its single use bioreactor portfolio. It is worth highlighting that mobius bioreactors include lab scale (3 L), pilot-scale (50 L and 200 L), and clinical scale (1000 L and 2000 L) bioreactors which provide a vast range of operational flexibility for the cell growth of both adherent and suspension cell lines.
Single Use Bioreactor Product Portfolio
The list of single use bioreactor that are being manufactured by the firm, along with information on the type of bioreactor is mentioned below:
| Product Name | Type of Bioreactor |
| Mobius® Breez Microbioreactor (2 mL) | Perfusion Bioreactor |
| Mobius CellReady 3L Bioreactor | Stirred Tank Bioreactor |
| Mobius 3 L Bioreactor | Stirred Tank Bioreactor |
| Mobius 3 L Bioreactor | Stirred Tank Bioreactor |
| Mobius 200 L Bioreactor | Stirred Tank Bioreactor |
| Mobius 1,000 L Bioreactor | Stirred Tank Bioreactor |
| Mobius 2,000 L Bioreactor | Stirred Tank Bioreactor |
Recent Developments and Future Outlook
In April 2023, the company announced the launch of its single use process container film in its Mobius bioreactors, which will help increase bag strength and provide leak resistance. In June 2022, MilliporeSigma acquired US based Erbi Biosystems in a bid to add a 2 mL single use microbioreactor Breez to its Mobius portfolio. We expect the company to continue with innovative solutions to meet the challenges faced with the use of single use technology for liquid handling. Further information related to Merck Millipore’s financial performance, product portfolio and recent developments is available in the full report.
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PBS Biotech claims to have expertise in the production of cost-effective scalable single use bioreactor and service for process development to resolve their existing cell culture associated challenges. The company states that their bioreactor can be used from R&D scale to large-scale manufacturing. The aforementioned bioreactors are based on its innovative Vertical-Wheel technology and can be used for the production of cell therapies, vaccines, and therapeutic proteins. The key elements of the company’s single use bioreactor are disposable bags and vessels, which are made of well-documented unique selling proposition (USP) class VI materials. Further, materials used for product contact surface layers are designed to reduce extractable and leachable containments. The vertical agitation technology enables homogenous mixing, high mass transfer, uniform particle suspension and reduced shear stress. One of the significant advantages offered by the product includes homogenous, low-shear and scalable mixing that helps in achieving rapid and more effective results. It is worth mentioning that the company maintains an in-house facility (located in Camarillo, California) for the manufacturing, assembly and inspection of disposable bags in order to maintain the highest quality standards.
Single Use Bioreactor Product Portfolio
The list of single use bioreactor that are being manufactured by the firm, along with information on the type of bioreactor is mentioned below:
| Product Name | Type of Bioreactor |
| PBS MINI 0.1 MAG | Stirred Tank Bioreactor |
| PBS MINI 0.5 MAG | Stirred Tank Bioreactor |
| PBS 3 (3 L) | Pneumatically Mixed |
| PBS 15 (15 L) | Pneumatically Mixed |
| PBS 80 (80 L) | Pneumatically Mixed |
Recent Developments and Future Outlook
In January 2023, the company procured a sum of USD 22 million from Avego Management for expansion of single use manufacturing of products and services for cell therapy clients. Earlier in July 2022, the company entered into a supply agreement with STEMCELL Technologies for process optimization and improvement of cell cultures leveraging PBS Mini bioreactor. We anticipate the company to continue to collaborate for strengthening its capabilities for supporting the cell therapy manufacturing market using single-use technologies.
Further information related to PBS Biotech’s financial performance, product portfolio and recent developments is available in the full report.
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Synthecon is a biotechnology firm that is focused on the designing and manufacturing of various 3D culture systems. It offers a diverse range of rotating single use bioreactor, under the trade name Rotary Cell Culture Systems (RCCS), for several applications in cell culture and tissue engineering. According to the company’s website, its technology is based on Rotating Wall Wessel (RWV) bioreactor, developed and patented by NASA. Currently, the firm is expanding its services in the field of stem cell culture for regenerative medicine. The firm is primarily involved in manufacturing RCCS for various 3D cell culture applications. These single use systems include gamma sterilized and individually packed bioreactors that allow wave-induced movement for the cell cultures. The company claims that it is first of its kind system that is designed to co-culture cells while enabling low shear force and high mass transfer rate for nutrients.
Single Use Bioreactor Product Portfolio
The list of single use bioreactor that are being manufactured by the firm, along with information on the type of bioreactor is mentioned below:
| Product Name | Type of Bioreactor |
| RCCS-1SC (single vessel system) | Rotating Bioreactor |
| RCCS-2SC (dual vessel system) | Rotating Bioreactor |
| RCCS-4SC (four vessel system) | Rotating Bioreactor |
| RCCS-4SCQ (four vessel system with =independent rotation of each vessel) | Rotating Bioreactor |
| RCCS-D | Rotating Bioreactor |
| RCCS-2D | Rotating Bioreactor |
| RCCS-4D | Rotating Bioreactor |
| RCCS-4DQ | Rotating Bioreactor |
| RCCS-8D | Rotating Bioreactor |
| RCCS-8DQ | Rotating Bioreactor |
Recent Developments and Future Outlook
The firm aims to build its reputation as the leading provider of innovative rotating cell culture technology. The company also mentions that it intends to expand the use of its technology into cell therapeutic applications and it has undertaken several research projects for this purpose. Examples of projects that have received funding from NIH SBIR grant program include improvement of pancreatic islet transplantation outcome and expansion of hematopoietic stem cells (HSCs) from umbilical cord blood through a tissue-engineered bone marrow analog. Synthecon raised $411,899 under a NIH grant in 2010.2 The company further aims to strengthen its offerings and expand its client base by establishing relationship with other industry / non-industry players engaged in this market.
Further information related to Sythecon’s financial performance, product portfolio and recent developments is available in the full report.
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Thermo Fisher Scientific is a company that focuses on accelerating research in the domain of life sciences and healthcare by addressing complex analytical challenges and delivering cutting-edge solutions for its customers. Through its market-leading brands, which include Applied Biosystems, Fisher Scientific, Invitrogen, Patheon, Thermo Scientific, and Unity Lab Services. Through these segments, the company conducts business in more than 600 locations. Further it is worth mentioning that the company’s single use bioreactor portfolio is comprised of HyPerforma single use bioreactor ranging from working volume of 1 L to 5,000 L. Their large volume 3,000 L and 5,000 L bioreactors were launched in 2021.3 The company though was not the first single use bioreactor manufacturer to provide a single use option for large scale biologics manufacturing. These bioreactors have been designed to optimize standard bioprocess such as cell culture production.
Single Use Bioreactor Product Portfolio
The list of single use bioreactor that are being manufactured by the firm, along with information on the type of bioreactor is mentioned below:
| Product Name | Type of Bioreactor |
| HyPerforma DynaDrive Single use Bioreactor (S.U.B.) 50 L | Stirred Tank Bioreactor |
| HyPerforma DynaDrive Single use Bioreactor (S.U.B.) 500 L | Stirred Tank Bioreactor |
| HyPerforma DynaDrive Single use Bioreactor (S.U.B.) 3000L | Stirred Tank Bioreactor |
| HyPerforma DynaDrive Single use Bioreactor (S.U.B.) 5000 L | Stirred Tank Bioreactor |
Recent Developments and Future Outlook
In February 2022, Thermo Fisher Scientific announced the investment of $40 million for the expansion of its single use technology manufacturing facility. The company mentioned that this facility will support to increase the production capacity of single use technology for vaccines and biologics. In April 2022, the company announced the opening of 55,000 sq. ft. single use technology facility in Utah, US. This expansion is a part of company’s long term $650 million investment that was announced previous year in March. Further, in August 2022, the company announced the opening of its largest single use technology manufacturing facility in Greater Nashville. The company expects to invest $105 million for the construction of 400,000 sq.ft. facility. The facility will support the company to meet the growing demand for biomanufacturing materials required for the production of vaccines and breakthrough therapies for cancer and other diseases. The firm is expected to take more such expansion initiative to support its existing single use bioreactor service portfolio and to expand it further in various geographical regions.
Further information related to Thermo Fisher Scientific’s financial performance, product portfolio and recent developments is available in the full report.
The above presentation features eight promising single use bioreactor manufacturers selected from a pool of over 60 manufacturers that we have compiled. If you're interested, you can download the Sample Report on this topic 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 sales@rootsanalysis.com.
Ankita_Kashyap is a business research and competitive intelligence professional with over four years of experience in the pharmaceutical and healthcare industry. As an associate at Roots Analysis, she has authored numerous trending multidisciplinary market research reports, including viral vectors, aseptic manufacturing, continuous manufacturing, bioprinting, ADC technology, membrane filtration, liquid biopsy and more. She has continuously provided her valuable insights into the latest innovations in healthcare. During her professional journey, she has acquired good analytical skills in the pharmaceutical and biopharmaceutical industry, which in turn has contributed to the firm’s intellectual capital. This has allowed our clients to make informed decisions in the dynamic pharmaceutical landscape. She embarked upon her career with us. She started her journey as a business analyst with Roots Analyst and in such a short span of time, she has demonstrated amazing dedication. Till date, she has contributed to over 20 research reports.
Ankita holds a Master’s degree in Pharmacology from Chitkara University. While pursuing her education, she contributed her skills for various review and research literature. The impact of her learnings can be found in her professional blogs, market research reports and social media profiles.
Source 1: https://www.cytivalifesciences.com/en/us/news-center/cytiva-and-pall-life-sciences-complete-integration-10001
Source 2: https://report.nih.gov/award/index.cfm?ot=&fy=2010&state=TX&ic=&fm=&orgid=2845201&distr=&rfa=&om=n&pid=#tab2
Source 3: https://www.labmanager.com/thermo-fisher-scientific-launches-3-000-l-and-5-000-l-hyperforma-dynadrive-single-use-bioreactors-s-u-b-s-for-cell-culture-production-2536
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