MaxCyte, Inc., a commercial cell engineering company, focuses on providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics including cell and gene therapies and to support innovative cell-based research and development.
The company has developed and commercialized its proprietary Flow Electroporation technology, which is used by biopharmaceutical companies in the complex engineering of a wide variety of cells.
The...
MaxCyte, Inc., a commercial cell engineering company, focuses on providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics including cell and gene therapies and to support innovative cell-based research and development.
The company has developed and commercialized its proprietary Flow Electroporation technology, which is used by biopharmaceutical companies in the complex engineering of a wide variety of cells.
The company’s ExPERT platform, which is based on its Flow Electroporation technology, has been designed to address this rapidly expanding cell therapy market, and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes four instruments, which are called the ATx, STx, GTx, and VLx, as well as a portfolio of proprietary related disposables and consumables. The company launched the ExPERT VLx instrument for very large-scale cell engineering in September 2022. The company’s disposables include PAs designed for use with its instruments, and its consumables include accessories supporting PAs, such as electroporation buffer solution and software protocols. The company has garnered meaningful expertise in cell engineering via its internal research and development efforts, as well as its customer-focused commercial approach, which includes an application scientist team. The platform is also supported by a robust intellectual property portfolio, with more than 200 granted U.S. and foreign patents, and more than 100 pending patent applications worldwide.
In January 2025, the company acquired SeQure Dx, (‘SeQure’), a market leader for on-target and off-target editing assessment services for cell and gene therapies.
Technology Platform
The foundation of the company’s technology platform is its proprietary and patented Flow Electroporation technology, which the company has developed and optimized for more than 25 years. Electroporation, or electro-permeabilization, leverages the fundamental properties of cell membranes, the ability to create reversible permeability in the presence of an electric charge, as a universal method to introduce foreign molecules, or transfect, eukaryotic cells, which are cells with a cell membrane and nucleus. Electroporation can be applied to almost any eukaryotic cell type to deliver a broad range of molecules, including DNA, human messenger RNA (‘mRNA’), small interfering RNA (‘siRNA’), and proteins. The company’s proprietary Flow Electroporation platform is fully scalable, and can support small-scale research and development through large-scale cell engineering for the development of commercial therapeutics.
The company’s technology platform is marketed under the ExPERT brand. The value of the company’s ExPERT brand starts with Efficiency—with high delivery Efficiency, users can achieve Potency; with high Potency, users improve their chances of therapeutic Efficacy; and if this can be repeated, Reproducibly from patient to patient, users can have a successful Therapy. By delivering high efficiency, while maintaining high cell viability, at any scale, the ExPERT platform is designed to improve its customers’ ability to achieve the required therapeutic index, enabling accelerated, cost-efficient translation of complex cellular therapies from research to clinical development.
The company’s ExPERT platform consists of four instruments, the ATx, STx, GTx, and VLx, which use a broad range of PAs, of different volumes to enable scalable electroporation from tens of thousands to billions of cells, to facilitate the translation of complex cellular therapies from concept to clinical development, in support of the intended therapeutic commercialization. The company’s family of instruments and PAs has been designed to support scale-up for cell therapy development.
ExPERT Platform
The company’s Flow Electroporation technology was designed to meet the stringent demands of clinical use—namely, the ability to safely and reproducibly modify a broad range of primary human cells with high efficiency, low cytotoxicity, at the scale required to enable the treatment of patients across a diverse range of diseases.
The ExPERT instrument family represents the next generation of the company’s clinically validated electroporation technology for complex and scalable cellular engineering. The combination of the ExPERT instruments, associated PAs, and consumables provides researchers, production scientists, and cGMP facilities with a solution to transfect cells with high efficiency, viability, and consistency, which are the three attributes that are consistently ranked by its customers as the top requirements when choosing a cellular or gene engineering platform for clinical use. The company’s instruments are sold or licensed for research or clinical use, while the associated PAs and consumables are sold to support pre-clinical research and development work, and are compatible for integration into cGMP manufacturing environments.
In addition, the company has implemented a global scientific and regulatory support strategy for its customers that is designed to accelerate clinical development, and help streamline the regulatory submission process.
The company’s ExPERT platform offers a compelling value proposition to its customers due to: the ability to use its technology to deliver almost any molecule into almost any cell type, including hard-to-transfect human primary cells, while maintaining high cell viability and function; the capacity to introduce larger and more diverse molecules, as well as multiple payloads, which exceeds the capabilities of other intracellular delivery technologies, such as viral vectors; and the flexibility to scale up from research to cGMP manufacturing on a single platform without the need for re-optimization—enabling the engineering of cells ranging from tens of thousands of cells to tens of billions of cells in a single transfection run in 30 minutes or less.
The company’s ExPERT intracellular delivery platform provides value across numerous applications in the life sciences market, including research, discovery, development, and manufacturing of next-generation, cell-based therapeutics, as well as in biomanufacturing, such as transient protein production for drug discovery, and manufacturing of other proteins, including biological therapeutics, viral vectors, and vaccines, and drug targets for small molecule drug discovery.
The company’s ExPERT technology platform is being used in the clinic to support the development of next-generation cell therapy approaches to treat human disease. Following the successful clinical development leading to FDA approvals of CAR-T cell therapies in blood-based cancers, developers have focused on improving efficacy, lowering the cost of manufacturing, and/or expanding engineered cell therapies into new indications, such as solid tumors, as well as autoimmune and neurodegenerative diseases.
Agreements with Customers
The company has a diverse portfolio of clinical customers and licensees that mirror the overall next-generation engineered ex vivo cell therapies. While difficult to predict given uncertainty around regulatory approvals and clinical risk, the first next-generation ex vivo cell therapy using non-viral approaches was approved in the United States in 2023 using its platform.
The company’s platform’s ability to engineer a diversity of cell types (including CAR-T, chimeric antigen receptor Natural Killer cells (‘CAR-NK/NK’), T cell receptor cells (‘TCR’), and stem cells) and cell sources (autologous and allogeneic) enhances its opportunity by potentially providing SPL agreement revenues regardless of which approaches advance in the coming years. Additionally, the company’s instruments and platform have been used in over 70 clinical trials to date for drugs being developed to treat a variety of indications, from hematological malignancies to solid tumors to inherited genetic disorders.
Products
ExPERT Instruments
The ExPERT instrument family was designed to provide a single unifying technology that can be used from concept to clinic, with both the research and clinical versions of an instrument incorporating the same underlying technology and protocols. The company’s customers have a choice of four different instrument versions that are standardized on the same technology to deliver equivalent high performance—ATx, STx, GTx, and VLx, as well as a portfolio of proprietary related PAs and consumables. Customers can start with the lower to medium scale research instrument (ATx), and then scale up to the clinical version (GTx) without the need for re-optimization or re-validation. The STx provides the same scale as the GTx, but is used for drug discovery applications, such as preclinical monoclonal antibody production, and not for human therapeutic use. VLx provides the capability for large-scale cell engineering and drug discovery applications. The STx is not covered by the company’s FDA Master File or its Technical Files.
The company’s platform allows its customers to perform their research and process optimization on a research platform, and seamlessly scale to a clinically validated, cGMP environment, and 21 CFR Part 11 compatible clinical platform.
The company’s instruments have been designed to provide customers with the key features required for a scalable high-performance transfection solution. Each of the company’s ExPERT instruments is benchtop with the same small footprint, and has integrated touch screens with an intuitive Graphical User Interface (‘GUI’), designed for simple training and operation. To support use in the cGMP suite for clinical manufacturing, the company’s GTx ExPERT software is network capable to enable upload of electronic batch records to a local shared drive, and has a software intermediary to facilitate integration and automated data transfer to cloud-based data management solutions. The company has integrated hardware and software design solutions, manufactured under cGMP, that are tailored for use in cGMP manufacturing of clinical products for advanced cellular therapies.
ExPERT ATx: Research focused, static electroporation for small to medium scale transfection
The company’s ExPERT ATx static electroporation instrument is a research-focused, high-performance electroporation platform for small to medium scale transfection. The ATx instrument delivers high efficiency and viability at research scale, and can utilize the company’s range of PAs capable of transfecting from 75,000 to 700 million cells. Additionally, the company’s ATx instrument is compatible with all of its static PAs, which can also be used on its GTx instrument, allowing for a seamless transition to its clinical cGMP-compatible platform. The ATx is designed and used by the company’s customers for early design of experiment and process optimization at small scale to minimize cell acquisition and reagent costs.
ExPERT STx: Flow Electroporation for protein production and drug development
The company’s ExPERT STx instrument, which is generally used in the field of protein production and for other drug discovery applications, also incorporates its proprietary Flow Electroporation Technology for high yield transient expression of proteins, viral vectors, vaccines, virus-like particles (‘VLPs’), and biologics. The company’s STx instrument has high efficiency, and can rapidly transfect from 75,000 to 20 billion cells.
ExPERT GTx: Flow Electroporation for large scale transfection in therapeutic applications
The ExPERT GTx incorporates the company’s proprietary Flow Electroporation technology for use in the cGMP manufacturing of cellular therapies with clinical uses.
The GTx integrates several design features that are critical for use in a cGMP setting, such as barcode reading capability to maintain positive identification of patient samples, 21 CFR Part 11 compatible software, and networking capability for automated uploading of electronic batch records to either a central server or to a cloud-based data management platform. The GTx enables closed sample processing, on a system compatible with integration into cGMP manufacturing environments, and that has an established regulatory path supported by the company’s FDA Master File and Technical Files.
ExPERT VLx: Designed for very large volume cell-engineering
The ExPERT VLx Large-Scale Transfection System is a cGMP compliant instrument specifically designed for very large volume cell-engineering. Using proprietary Flow Electroporation technology, the VLx supports the ability to transfect up to 200 billion cells in less than 30 minutes—10 times the capacity of the STx and GTx. This system is designed for the rapid and large-scale production of recombinant proteins, monoclonal antibodies, viral vectors, vaccines, VLPs, and allogeneic cell therapies. The company launched the VLx under the ExPERT brand in September 2022 to provide customers with an easy-to-use, large-scale system that incorporates the benefits of the ExPERT platform for large-scale bioprocessing. As of September 2023, the VLx had an established regulatory path supported by the company’s FDA Master File.
Disposables—Processing Assemblies (PAs)
The company’s range of disposable PAs is an important differentiator for it. The company views its PA designs as one of the key contributors to the capacities, high efficiency, and viability delivered by the ExPERT platform.
The company has developed a broad range of PAs that are specially designed to process and electroporate the user’s chosen quantity of cells. Each PA contains two electrodes, between which a medical-grade gasket is sandwiched that has a unique well design consistent with the processing volume required, and to allow maximum retrieval of cells. The company’s PAs are capable of electroporating cell volumes from small to large scale, in single and multi-well formats, for both research and clinical use. Cells are placed into the sample bag in large scale PAs, or into the well or wells in small scale PAs, and the PA is then connected to the instrument for processing. The instrument touch screen allows the operator to select the desired cell protocol that encodes the electroporation parameters, select the type of PA to be used, and enter any sample-specific information. Once the sample information has been entered, the operator will touch the ‘Start Processing’ icon on the user interface, and the sample will be rapidly processed. Larger volumes of cells are accommodated by larger capacity PAs, and a set of simple software commands through the intuitive GUI.
The company’s ExPERT system uses two classes of PA designs—a static cuvette used for smaller cell volumes (from 75,000 cells up to 200 million cells), and a cartridge design that is used for both static and Flow Electroporation for larger cell volumes (700 million up to tens of billions of cells). The Flow Electroporation PA (‘Flow PA’) allows for processing of cellular volumes ranging from 5 mL to 1,000 mL, and up to tens of billions of cells. The Flow PA consists of bags and associated tubing, made from medical-grade materials, that are connected to the electroporation cartridge. Users transfer their cells and loading molecules to the sample bag, and the pump on the GTx, STx, or VLx instrument pumps a fixed volume of cells into the cartridge chamber where they are electroporated. Once the electroporation is complete, the cells are pumped to the collection bag, and the chamber is filled with the next volume of cells for electroporation. This process is repeated until the entire sample volume is processed. The maximum volume of 1,000 mL of cells can be processed in less than 30 minutes.
The company has conducted extensive end-user research to continue improving the design of the PAs and the range of products available. The company launched the ExPERT cuvette in 2020 based on customer feedback, which incorporated a new design to improve handling and ease of use, and the company has continued to expand the availability of the ExPERT PA portfolio design. The company has also expanded its portfolio of multi-well cuvettes, which reduce manual handling and improve productivity in the lab, with the launch of its R-50x8. The R-50x8 is an 8-well cuvette capable of processing up to 225,000 cells in each well. By enabling eight samples to be processed in the same cuvette, a more efficient process can be achieved by users.
In 2022, the company added the R-20K Flow Electroporation Processing Assembly for its STx and GTx platforms, which can process between 5 mL and 20 mL sample volumes, which can accommodate between 200 million and up to 4 billion cells. The R-20K assembly allows clients to develop therapies at small or mid-scale volumes with improved cell recovery in a closed process adaptable format to assist in de-risking their manufacturing process at the electroporation step. To further support the company’s customers’ sterile closed process workflows, the company also introduced ‘Closed Process Electroporation Buffer’ products in two volume sizes, 500 mL and 1 Liter, which allow for the addition of its proprietary electroporation buffer to concentrated cell samples before electroporation. At the same time, for the company’s VLx Platform, the company introduced the R-1L Flow Electroporation Processing Assembly, which can process in 30 minutes or less between 100 mL and 1 Liter sample volume accommodating up to 200 billion cells in a single run. The R-1L assembly allows for large volume sample processing that can be adapted to a closed and sterile workflow for continuous end-product production.
The company is committed to strategically investing in improvements in the PA design and range of products to ensure that customers have solutions that address all of their volume and use requirements, in both research and clinical settings, including current development of advancements for PA that support the VLx.
Supporting Products
The company’s proprietary electroporation buffer, a balanced salt solution that protects cells during transfection, is formulated for use with all its instrument platforms and PAs. This consumable is used for all cell types, eliminating the need to change buffers as users switch protocols, cell types, or scale up. The buffer is made in a cGMP facility, is fully chemically defined, and is free of human or animal components, and is tested to meet technical, sterility, and endotoxin specifications. This buffer formulation is a key contributing factor, in combination with instrument and PA design features, to the flexibility, high efficiency, and viability that can be achieved by customers across the broad range of cell types processed using its platform. With the acquisition of SeQure in January 2025, the company acquired a suite of assays and a service offering conducting those assays. These assays and associated services assess the risk that gene editing technologies have unintended consequences for the genome.
Sales and Marketing
The company follows a direct sales model in North America, the United Kingdom, and Europe, while also selling through third-party distributors in Asia and some regions of Europe. As of December 31, 2024, the company had over 33 field sales and application scientists located in the United States, the United Kingdom, and several regions in Europe and Asia. Since the commercial launch of the company’s first Flow Electroporation instrument in 2003, the installed base of its instruments has grown to more than 760 instruments globally.
The company’s sales force, field application scientists, and international partners inform its potential customers of product offerings, new target applications, and advances in its technologies and products. As the company’s primary point of contact in the marketplace, its field teams focus on delivering a consistent marketing message and a high level of customer support, while also working to help it better understand the evolving market and customer needs. The company intends to expand its sales, support, and marketing efforts in regions, such as those within the Asia-Pacific region. The company uses distributors in countries in these regions, such as in China and Japan, supplemented by dedicated MaxCyte team members, and continuously assesses the need for direct sales and local support personnel to supplement the company’s distributors’ resources. When the company expands into a new geography, it generally relies initially on third-party distributors until it is able to recruit a direct sales force, field application scientists, and business development resources in the country or region.
The company’s business model is focused on identifying new applications in cell engineering to enable its customers to develop better medicines, and maximize use across its customers’ value chains. This is enabled through customer partnerships that allow it to further understand the critical applications for its technology, and inform its future developments and market expansion.
Research and Development
The company’s research and development expenses totaled $22.2 million in the year ended December 31, 2024.
Intellectual Property
As of February 19, 2025, the company had more than 200 granted U.S. and foreign patents, including in Australia, Canada, Japan, China, South Korea, and certain countries in Europe, as well as over 100 pending patent applications worldwide. The company’s portfolio protects its core technology, the Flow Electroporation process, the processing assemblies and consumables, control and process elements, and application methods of using its non-viral delivery platform. The protection over the company’s instruments and related methods is estimated to last through at least 2028, and through 2037 for its electroporation applications. The company’s design protection covering the ExPERT system has the potential to provide protection through at least 2048.
One key element of this protection is the company’s FDA Master File and Technical Files, which allow it to submit to the regulatory authorities confidential detailed information about its ExPERT system and PAs. The relevant submission can be referenced by the company’s customers or licensees to support their own regulatory filings without the need for it to disclose the confidential information contained in the FDA Master File and Technical Files.
The company also seeks to protect its brand through the procurement of trademark rights. As of February 19, 2025, the company owned 22 registered trademarks in the United States, over 155 registered foreign trademarks, 9 pending U.S. trademark applications, and more than 20 pending foreign trademark applications. This collection includes trademarks for its company name, logos, and stylized versions of its ExPERT product line names.
Government Regulation
The company’s biopharmaceutical and life sciences customers are subject to extensive regulations by the U.S. Food and Drug Administration (the ‘FDA’) and similar federal, state, and local authorities, as well as their foreign equivalents, regarding the conduct of preclinical studies and clinical trials, in the manufacture of product candidates and products for use in humans (i.e., ‘Good Manufacturing Practices’ laws and regulations) and the marketing authorization and commercialization of biological and drug products.
In order to support the company’s customers’ use of its platform in regulatory submissions, the company has submitted Master Files to the FDA, Center for Biologics Evaluation and Research, and Master Files and/or Technical Files to comparable regulatory authorities in other jurisdictions, including Canada, Japan, Australia, the United Kingdom, and Austria, and provides nonexclusive Letters of Authorization to the Master or Technical Files under contractual agreements with its customers. In this way, the regulatory body may review information on the company’s platform in the context of its utilization by its customers in regulated products, for example, as described in its customers’ INDs or BLAs. The company continuously updates the Master and Technical Files in order to support the regulatory activities of its customers. The FDA allows Master Files, but they do not approve them. Rather, they review them in the context of evaluating the submissions by its customers that reference its files.
Competition
The company primarily competes against products marketed by Lonza Group AG, Thermo Fisher Scientific Inc. (NYSE: TMO), Miltenyi Biotec, Bio-Rad Laboratories, Inc. (NYSE: BIO), and Harvard Bioscience, Inc. (Nasdaq: HBIO), as well as several other smaller companies, including spinouts from academic labs.
History
MaxCyte, Inc. was incorporated under the laws of the State of Delaware in 1998.
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