Repligen Stock

Repligen Corporation (Repligen) operates as a global life sciences company.

The company develops and commercializes highly innovative bioprocessing technologies and systems that increase efficiencies and flexibility in the process of manufacturing biological drugs.

The company's primary customers are global biopharmaceutical companies, contract development and manufacturing organizations, and other life science companies (integrators).

The company is committed to inspiring advances in bioprocessing as a trusted partner in the production of critical biologic drugs - including monoclonal antibodies ('mAbs') and mAb derivatives, recombinant proteins, vaccines, and cell and gene therapies ('C>') - that are improving human health worldwide. Increasingly, the company's technologies are being implemented to overcome challenges in processing plasmid DNA (a starting material for the production of mRNA) and gene delivery vectors such as lentivirus and adeno-associated viral vectors.

The company operates as one bioprocessing business, with a comprehensive suite of products to serve both upstream and downstream processes in biological drug manufacturing.

Products

The company's bioprocessing business is consisted of four main franchises: filtration (including fluid management); chromatography; process analytics; and proteins.

Since 2012, the company has purposely built a highly diversified portfolio of products offered under these franchises, developing high-value technologies that enable more efficient drug manufacturing processes for the company's customers, through internal research and development ('R&D') programs and strategic acquisitions. The company is committed to sustainable innovation and have earned a reputation as an innovation leader in bioprocessing. The company has consistently introduced disruptive new products that solve for specific bioprocessing challenges faced by customers. The company's growth strategy continues to expand the company's geographic scope and customer base and broaden the applications of the company's technologies.

To support the company's sales goals for these products, the company makes ongoing investments in its commercial organization, the company's R&D programs, its business systems and its manufacturing capacity. The company regularly evaluates and invests in these areas as needed to ensure timely deliveries and to stay ahead of customer demand for the company's products.

The majority of the company's revenue is derived from consumable and/or single-campaign ('single-use') product sales, as compared to associated hardware and equipment.

Shifting to Integrated Solutions

Since 2012, the company has completed 13 acquisitions across the company's four franchises, building a base of technology assets that the company can improve upon and/or develop next-generation versions of through the company's internal R&D team. The company's acquisition strategy is purposeful, considering the potential for integration with the company's internally-developed technologies, and across products and franchises.

In 2023, the results of the company's mergers and acquisitions and R&D efforts are reflected in the company's ability to offer more integrated solutions across the bioproduction workflow. The company's commercial approach is shifting from 'individual product' to 'whole system' sales that can support entire unit operations, the management of fluids between unit operations, and in-line advanced analytics. For example, providing filtration systems for production and harvest steps (upstream), and connecting those to chromatography and filtration systems for purification and formulation steps (downstream).

Key Products Within Each of the company's Franchises

Filtration

Filtration is the company's largest franchise with the broadest product offering covering upstream and downstream technologies. Below is a description of some of the company's key products:

XCell ATF Cell Retention Systems

The company's filtration products offer a number of advantages to manufacturers of biologic drugs and are used in process development and process scale (clinical and commercial) production. The company's XCell ATF systems are used in upstream perfusion (continuous) and N-1 (intensified fed-batch or hybrid perfusion) cell culture processing.

XCell ATF is a cell retention technology. The system is consisted of an advanced hollow fiber ('HF') filtration device, a low shear pump and a controller. The XCell ATF system is connected to a bioreactor and enables the cell culture to be run continuously, with cells being retained in the bioreactor, fresh nutrients (cell culture media) being fed into the reactor continuously, and clarified biological product and cell waste being removed (harvested) continuously. The cells are maintained in a consistent nutrient-rich environment and can reach cell densities two- and three-times higher than those achieved by standard fed-batch culture. As a result, product yield is increased, which improves facility utilization and can reduce the size of a bioreactor required to manufacture a given volume of biologic drug product. XCell ATF systems are available in a wide range of sizes that can easily scale from laboratory use through full production with bioreactors as large as 5,000 liters.

Through internal innovation, the company developed and launched single-use formats of the original stainless steel XCell ATF devices to address increasing industry demand for single-use sterile systems with 'plug-and-play' technology. The XCell ATF device is now available to customers in both its original configuration (steel housing and single-use filters) in all sizes (2, 4, 6 and 10), and/or as a single-use device (disposable housing/filter combination) in most sizes (2, 6, and 10). The availability of XCell ATF technology in a single-use format reduces implementation time by eliminating the time intensive workflow associated with autoclaving and enables the company's customers to accelerate evaluations of the product with a lower initial overall cost of ownership.

In 2023, the company introduced next-generation XCell Large-Scale controllers, enabling increased process intensification through dual-operation of ATF devices from a single controller, and through advance monitoring and control of flow rates with smart sensor technology. The company's ATF large-scale controllers are designed for scalability from bench top to commercial manufacturing, and for versatility of applications, including perfusion and modified fed-batch (N-1) manufacturing.

Tangential Flow Filtration Consumables

The company's TangenX product portfolio includes flat sheet ('FS') tangential flow filtration ('TFF') cassettes that are used primarily in downstream, ultrafiltration processes, e.g., biologic drug concentration, buffer exchange and formulation processes, the company's single-use SIUS line, including the company's reusable PRO line of cassettes, providing customers with a high-performance, cost saving alternative to other companies' TFF cassette offerings and the company's TangenX SC Device, the industry's first holder-free, self-contained ('SC') TFF device, which was launched in November 2023.

The company's TangenX FS TFF cassettes feature high performing-membrane chemistries that offer superior selectivity for a wide range of applications. A controlled manufacturing process that balances flux and selectivity delivers maximum flux for increased productivity and tight control of the membrane pore size for enhanced selectivity and recovery. Each single-use cassette is delivered pre-sanitized and ready to be equilibrated and used for tangential flow, ultrafiltration and diafiltration applications.

Use of SIUS TFF cassettes eliminates non-value-added steps (cleaning, testing between uses, storage and flushing) that are required with reusable TFF products, providing cost and time savings. For process economics requiring reusable cassettes, TangenX PRO cassettes are available with the same high performance membranes used in SIUS cassettes. The company's TangenX cassettes are interchangeable with filter hardware from multiple manufacturers, simplifying customer trial and adoption. In 2020, the company introduced SIUS Gamma single-use device, which the company engineered to harness the performance and efficiencies of TangenX SIUS membranes and cassettes, while also providing the convenience of a fully assembled, aseptically closed and gamma-irradiated, sterile device. The device is delivered as a single unit composed of the cassette, fluid manifold, clamps, tubing and aseptic connectors. The SIUS Gamma device is ideal for adenovirus C> and other processes where large volumes need to be concentrated in a sterile, closed environment.

The company's TangenX SC Device simplifies and streamlines downstream flat sheet UF/DF processes by reducing set up time by 80%, eliminating holders and torquing requirements, which reduces the risk of product loss caused by changes in compression or cassette misalignment during installation, allowing users to seamlessly transition from traditional cassettes and reducing bioburden risk and enhancing safety because it is aseptically closed and gamma irradiated and isolates operators from potentially hazardous materials.

Tangential Flow Filtration Systems: KrosFlo TFF

The company's KrosFlo systems for TFF combine significant configurability with premium quality manufacturing. The company's TFF systems are designed for scalability from small to large (up to 5,000 liters) volumes, flexibility between HF and FS filter formats, and the ability to use the same system in different unit operations while deploying ready-to-use application-specific flow paths.

The company's KrosFlo TFF systems are turnkey solutions for TFF, offered with either TangenX FS cassettes or with the company's HF filters.

KrosFlo Flat Sheet TFF Systems

The company's 2020 acquisition of ARTeSYN Biosolutions Holdings Ireland Limited ('ARTeSYN') enabled the company to develop and market KrosFlo RS TFF systems that integrate the company's consumable and equipment offering, providing greater convenience and efficiency for the company's customers.

The company launched its KrosFlo RS 20 series systems in 2022, focusing their use in mRNA and C> therapy applications, where they are used primarily in downstream formulation. These responsive TFF systems completely automate sanitization, concentration and product recovery processes. The combination of injection molded tubing, over-molded connectors and valve blocks significantly lowers product hold-up volume to maximize product recovery. With the same software, hardware, controls and cGMP compliance built into every system, and with pre-assembled flow kits for error-free installation, the KrosFlo RS platform offers operational simplicity that can easily be scalable from lab- through production-scale use. KrosFlo FS systems integrate over 10 components with specifications to process volumes between 140 milliliters and 500 liters.

KrosFlo Hollow Fiber TFF Systems

The company's filtration business is strengthened by a leading portfolio of Spectrum HF filtration solutions, including fully integrated KrosFlo TFF systems with Konduit automated process monitoring and ProConnex Flow Path single-use assemblies. The KrosFlo family of HF TFF systems integrate multiple components with specifications to process volume between 2 milliliters and 5,000 liters - from lab-scale through commercial manufacturing.

In early 2023 the company introduced its RS 30 series of KrosFlo TFF systems, featuring increased automation capabilities. The RS 30 series systems integrate a single-use tulip tank re-circulation vessel, which allows for dynamic control and response to changing fluid levels for maximum product recovery in fed-batch, batch concentration and diafiltration processes. The cGMP compliant, fully automated 1/2 inch single-use TFF system delivers outstanding performance in a small footprint. In alignment with the company's integrated systems strategy, the system includes ProConnex flow paths to integrate advanced fluid management technologies, including overmolded connections, pump heads, tubing filters and sensors in a single-use device. Flow paths easily attach to the system to simplify operation and increase process efficiency.

Tangential Flow Depth Filtration Systems: KrosFlo TFDF

The company's KrosFlo Tangential Flow Depth Filtration ('TFDF') systems, have the potential to disrupt and displace traditional upstream harvest clarification operations. The KrosFlo TFDF system includes control hardware, novel high throughput tubular depth filters and ProConnex TFDF flow paths. When used for cell culture clarification, single-use KrosFlo TFDF technology delivers unprecedented high flux (>1,000 LMH), high capacity, low turbidity, and minimal dilution, making the technology a high-performance alternative to traditional centrifugation and depth filtration approaches to harvest clarification. TFDF technology also provides benefits such as low hold-up volume, high recovery, small footprint, simple set up and disposal, scalability and reduced process time.

Strengthening the company's Filtration Franchise through Acquisitions

With the company's acquisition of Polymem S.A. ('Polymem') on July 1, 2021, the company further expanded its HF membrane and module production capabilities and added core R&D, engineering and production expertise in HF technology for both industrial and bioprocessing markets. The Polymem business complements the company's Spectrum HF product line, which includes KrosFlo HF TFF systems and ProConnex fluid management. The acquisition of Polymem accelerated the company's HF manufacturing buildout and added a Europe-based HF manufacturing center of excellence.

With the company's acquisition of BioFlex Solutions LLC ('BioFlex') and Newton T&M Corp. ('NTM') on December 16, 2021, the company complemented and expanded the company's filtration franchise, as both BioFlex and NTM focus on single-use fluid management components, including single-use clamps, adapters, end caps and hose assemblies. These products are essential components in the company's upstream and downstream product offerings - especially the company's systems with line-sets and flow paths. These acquisitions streamline and increase the company's control over many components in its single-use supply chain, which ultimately should drive reduced lead-times for the company's customers in the coming years.

The company acquired FlexBiosys, Inc. ('FlexBiosys') on April 17, 2023, further complementing and expanding the company's fluid management portfolio of offerings with its expert design and custom manufacturing of single-use bioprocessing products and a comprehensive range of products that include bioprocessing bags, bottles, and tubing assemblies.

With the company's acquisition of Metenova Holding AB ('Metenova') on October 2, 2023, the company strengthened the company's fluid management portfolio with the addition of magnetic mixing and drive train technologies that are widely used by global biopharmaceutical companies and contract development and manufacturing organizations.

The growth of the company's filtration business has allowed the company to substantially increase the company's direct sales presence in Europe and Asia and diversify the company's end markets to include all biologic classes, including mAbs, vaccines, recombinant proteins and C>.

Chromatography

The company's chromatography franchise includes a number of products used in downstream purification, development, manufacturing and quality control of biological drugs. The main driver of growth in this portfolio is the company's OPUS pre-packed column ('PPC') product line.

In addition to OPUS, with the company's acquisition of ARTeSYN in 2020, the company added chromatography systems to its offerings, providing greater flexibility and market opportunity as the company scales and expands its systems portfolio.

Additional chromatography products include the company's affinity capture resins, such as CaptivA Protein A resins, which are used in a small number of commercial drug processes and the company's ELISA test kits, used by quality control departments to detect and measure the presence of leached Protein A and/or growth factor in the final product.

OPUS Pre-Packed Columns

The company's chromatography franchise features a wide range of OPUS columns, which the company delivers to its customers sealed and pre-packed with their choice of resin. These are single-use or campaign-use disposable columns that replace the use of customer-packed glass columns for downstream purification. By designing OPUS columns to be a technologically advanced and flexible option for the purification of biologics from process development through clinical and commercial-scale manufacturing, Repligen has become a leader in the PPC market.

The company launched its first production scale OPUS columns in 2012 and have since added larger diameter options that scale up to use with 2,000 liter bioreactors. The company's OPUS 80R column is the largest available PPC on the market for use in late-stage clinical or commercial purification processes. The company offers unique features, such as a resin recovery port on its larger columns, which allows the company's customers to remove and reuse the recovered resin in other applications. The OPUS 5-80R product line is the most flexible product line available in the market, serving the purification needs of customers manufacturing mAbs and other biologics, such as vaccines and C>.

In addition to the company's larger scale OPUS columns, its portfolio includes the company's smaller-scale OPUS columns, including its RoboColumn, MiniChrom and ValiChrom columns used for process development ('PD') and validation. These columns are used in high-throughput PD screening, viral clearance validation studies and scale down validation of chromatography processes.

The company maintains customer-facing centers in both the United States and Europe for the company's OPUS column customers, and offer a premier ability to pack any of hundreds of chromatography capture resins available, as per the company's customers' choice.

KRM Chromatography Systems

Through the company's acquisition of ARTeSYN in 2020, the company gained configurable chromatography systems that can integrate a wide range of hardware, components and consumable products to simplify bioprocessing operations for the company's customers. The company's KRM chromatography systems are precision engineered for high product recovery (low hold-up volumes), high bioactivity (less stress on the product of interest) and reduced risk of deviation (simple changeovers and pre-assembled flow kits). The KRM systems contain closed single-use flow paths (less risk of contamination and product loss) and other advanced fluid management technologies (over-molded connectors, pump heads, filters and pressure sensors), intuitive software and the company's process analytics technology enabled.

Process Analytics

The company's process analytics products complement and support the company's filtration, chromatography and proteins franchises as they allow end-users to make at-line or in-line absorbance measurements allowing for the determination of protein concentration in filtration, chromatography formulation and fill-finish applications.

SoloVPE Device

The company's SoloVPE slope spectroscopy system is the industry standard for offline and at-line absorbance measurements for protein concentration determination in process development, manufacturing and quality control settings.

FlowVPE Device

The company's FlowVPE slope spectroscopy system enhances the power of slope spectroscopy and provides in-line protein concentration measurement for filtration, chromatography and fill-finish applications. A key benefit of this in-line solution is the ability to monitor a manufacturing process in real time.

FlowVPX System

FlowVPX slope spectroscopy system is the company's next-generation FlowVPE launched at the beginning of 2021 and designed to meet the rigors of regulatory GMP requirements. FlowVPX offers reliable real-time results with integrated ease for concentration measurements during every stage of the downstream GMP-compliant production-scale biologics manufacturing.

Use of slope spectroscopy systems delivers multiple process benefits for the company's biopharmaceutical manufacturing customers, compared to traditional UV-Vis approaches. Key benefits include: the elimination of manual dilutions and sample transfers from process development/manufacturing to labs, rapid time to results (minutes versus hours), improved precision, built-in data quality for improved reporting and validation, and ease of use.

KrosFlo RPM Systems with integrated FlowVPX Technology

In 2022, the company completed the development of a HF system that combines KrosFlo TFF with FlowVPX Real-Time Process Management ('RPM') technology, enabling 'walk-away automation' of downstream UF/DF processes. Toward the end of 2022, the company launched KrosFlo DR2i RPM for low-volume, high concentration applications. This was the first-to-market TFF system to incorporate real-time process monitoring for in-line protein concentration management. By coupling KrosFlo TFF and FlowVPX functionality, customers can benefit from improved process control and efficiency, while reducing process risk by ensuring accurate concentration throughout the TFF process.

KrosFlo RPM systems monitor concentration during UF/DF runs without having to depend on mass inputs and off-line fixed pathlength UV-Vis spectrophotometers. Risk is further mitigated with fully enclosed ProConnex custom flow paths as a part of the automated TFF process.

Since the debut of the KrosFlo KR2i RPM (2 mL-15L) system, the company expanded the KrosFlo RPM offering, introducing KrosFlo FS-15 RPM (150mL-15L) toward the end of 2023. The portfolio continues to expand to cover a wide range of volumes from lab-to production-scale requirements. KrosFlo RPM solutions provide key process insights to users to reduce cycling time and minimize batch risks, both highly value attributes for bioprocessing users.

Culpeo QCL-IR Liquid Analyzer

Pursuant to a 15-year license agreement that the company entered into with DRS Daylight Solutions, Inc. ('Daylight') in September 2022, the company obtained the exclusive right to use Daylight's quantum cascade laser technology ('QCL'), including its Culpeo QCL-IR Liquid Analyzer ('Culpeo') specifically in the field of bioprocessing. Culpeo is a compact, intelligent spectrometer that uses the power of QCL to analyze and identify chemicals. The company's in-licensing of these rights complements the company's existing process analytics franchise. Adding mid-IR (higher sensitivity QCL-IR) to UV spectroscopy, this will serve to accelerate and expand adoption of off-line and in-line process monitoring in the bioprocessing industry. Additionally, the company is focused on expanding the QCL portfolio, with plans to integrate these solutions into the company's chromatography and filtration systems.

Proteins

The company's proteins franchise is represented by its Protein A affinity ligands and viral vector affinity ligands and resins. The company's proteins franchise also includes cell culture growth factor products, which are a key component of cell culture media used in upstream bioprocessing to increase cell density and improve product yield.

Protein A Affinity Ligands

The company is a leading provider of Protein A affinity ligands to other life sciences companies (integrators), whose final products are Protein A resins. Protein A ligands are an essential 'binding' component of Protein A affinity chromatography resins used in the purification of virtually all mAb-based drugs on the market or in development. The company manufactures multiple forms of Protein A ligands under long-term supply agreements with major life sciences companies, including Cytiva (a standalone operating company owned by Danaher Corporation), MilliporeSigma and Purolite, an Ecolab Inc. company ('Purolite'), who in turn sell their Protein A chromatography resins to end users (mAb manufacturers). The company has two manufacturing sites supporting overall global demand for the company's Protein A ligands: one in Lund, Sweden and the other in Waltham, Massachusetts.

Affinity Ligand Collaborations

In June 2018, the company entered into an agreement with Navigo Proteins GmbH ('Navigo') for the exclusive co-development of multiple affinity ligands for which Repligen holds commercialization rights. The company manufactures and exclusively supplies the first of these ligands, NGL-Impact A, to Purolite, for use with their Praesto Jetted A50 Protein A resin product.

In September 2021, the company and Navigo successfully completed co-development of a novel affinity ligand that addresses aggregation issues associated with pH sensitive antibodies and Fc-fusion proteins. The company is manufacturing and supplying this ligand, NGL-Impact HipH, to Purolite for use in a platform use resin product.

The company has a long-term supply agreement with Purolite for NGL-Impact and potential additional affinity ligands that may advance from the company's Navigo collaboration.

Purolite Agreement

In October 2022, the company extended its long-term supply agreement with Purolite through 2032 and broadened its scope to include affinity ligands targeting antibody fragments in addition to those targeting mAbs and Fc-fusion proteins. This extension and product line expansion aligns with the company's Proteins strategy and supports the acceleration in market adoption of the Praesto affinity resin portfolio. It provides Purolite with exclusive access to mAb fragment ligands developed at Avitide, Inc. ('Avitide'), in addition to the NGL portfolio developed at Navigo. Repligen will continue to receive access to Purolite's leading-edge base bead technology, as the company proceeds with the development and commercialization of novel affinity resins focused on new modalities and C>.

mAb Fragment Affinity Ligands and Resins from Avitide

The company's acquisition of Avitide also led to its development and 2022 launch of AVIPure CH1, a cross-linked agarose-based resin specifically engineered for the capture of the CH1 region of antigen-binding fragments ('Fabs') from human immunoglobins ('IgGs') and mAbs. The high dynamic binding capacity for Fab and IgG1 even at short residence times position these resins well for market success.

Adeno-Associated Virus Affinity Ligands and Resins from Avitide

In September 2021, the company completed its strategic acquisition of Avitide, a market leader in affinity ligand discovery and development. This acquisition was a major step forward in building the company's proteins franchise, moving Repligen into affinity resin solutions for C> and other emerging modalities.

In February 2022, the company launched three advanced affinity chromatography resins for use in gene therapy manufacturing workflows. The resins AVIPure-AAV9; AVIPure-AAV8; and AVIPure-AAV2, were developed by Avitide and are specific to the major adeno-associated virus ('AAV') C> vectors used today. AAV vectors are the leading platform for gene delivery for the treatment of a variety of human diseases. In 2023, a new affinity resin for AAV5 was also launched, expanding the portfolio.

The company is integrating these high performance AVIPure resins with the company's OPUS PPC and ARTeSYN chromatography systems to provide the company's customers with a seamless chromatography solution.

Growth Factors

The company's cell culture growth factor additives include LONG R3 IGF 1, the company's insulin-like growth factor that has been shown to be up to 100 times more biologically potent than insulin (the industry standard), thereby increasing recombinant protein production in cell culture fermentation applications.

2023 Acquisitions

Metenova Holding AB

On October 2, 2023, the company's subsidiary, Repligen Sweden AB, acquired Metenova from the former shareholders of Metenova (the 'Metenova Seller') pursuant to a Share Sale and Purchase Agreement (the 'Share Purchase Agreement'), dated as of September 23, 2023 (such acquisition, the 'Metenova Acquisition'), by and among Repligen Sweden AB, the Metenova Seller, and the company, in the company's capacity as guarantor of the obligations of Repligen Sweden AB under the Share Purchase Agreement.

Metenova, which is headquartered in Molndal, Sweden, offers magnetic mixing and drive train technologies that are widely used by global biopharmaceutical companies and contract development and manufacturing organizations. The Metenova Acquisition further strengthens the company's fluid management portfolio with these products.

FlexBiosys, Inc.

On April 17, 2023, the company completed the acquisition of all of the outstanding equity interests in FlexBiosys, pursuant to an Equity Purchase Agreement with FlexBiosys, TSAP Holdings Inc. ('NJ Seller'), Gayle Tarry and Stanley Tarry, as individuals (collectively with NJ Seller, the 'FlexBiosys Sellers'), and Stanley Tarry, in his capacity as the representative of the FlexBiosys Sellers.

FlexBiosys, which is headquartered in Branchburg, New Jersey, offers expert design of custom manufacturing of single-use bioprocessing products and a comprehensive range of products that include bioprocessing bags, bottles, and tubing assemblies. These products will complement and expand the company's fluid management portfolio of offerings.

Strategy

The company is focused on the development, production and commercialization of highly differentiated, technology-leading systems and solutions that address specific pressure points in the biologics manufacturing process and deliver substantial value to the company's customers. The company's products are designed to optimize the company's customers' workflow to maximize productivity and the company is committed to supporting the company's customers with strong customer service and applications expertise.

The company's strategies include continued innovation; platforming the company's products; targeted acquisitions; and geographical expansion.

Sales and Marketing

The company's sales and marketing strategy supports its intention of strengthening the company's position as a leading provider of products and services, addressing upstream, downstream and quality control needs of bioprocessing customers in the biopharmaceutical industry.

Ligand Supply Agreements

For the company's proteins franchise, the company is committed to be a partner of choice for the company's customers with distributor and supply agreements in place with large life sciences companies such as Cytiva, MilliporeSigma and Purolite. The Cytiva Protein A supply agreement relating to the company's Waltham, Massachusetts facility was amended in September 2021 and pursuant to its amended terms, runs through 2025. The company's Protein A amended supply agreement with Purolite was amended in October 2022 and, pursuant to its amended terms, runs through 2032. The company's dual manufacturing capability provides strong business continuity and reduces overall supply risk for the company's ligand customers.

Significant Customers and Geographic Reporting

Customers for the company's bioprocessing products include major life sciences companies, contract manufacturing organizations, biopharmaceutical companies, diagnostics companies and laboratory researchers.

Intellectual Property

The company owns or has exclusive rights to at least 263 active patent grants and 369 pending patent applications in the United States and other foreign jurisdictions, including Australia, Canada, China, France, Germany, India, Japan, South Korea, Sweden and the United Kingdom.

Filtration

For the company's filtration franchise, its patent grants include coverage for, ATF filtration, TFDF and TFF HF and FS systems, membranes, filters, mixers flow paths and single-use technologies. The company continually seeks to improve upon these technologies and have multiple new patent filings, including patents covering next generation TFDF filters, next generation ATF filtration technologies, and proprietary reduced cost system components.

Chromatography

The company's patent grants include coverage for certain unique methods and features of the company's OPUS PPC, including methods of manufacturing column components, systems for removing air using specialized tubing and valve systems, medium recovery systems, methods for packing, as well as systems for testing chromatography columns.

Through the ARTeSYN Acquisition in 2020, the company's patent portfolio includes exo-technology, valves, integrated sensors and integrated flow path systems. The company also has multiple patent grants pertaining to its single-use replacement valves and liners used in combination with the company's modular configurable encapsulated flow systems to provide sterilized flow paths for various bioprocessing applications.

Process Analytics

Through the company's 2019 acquisition of C Technologies, Inc. ('C Technologies'), the company holds patent grants to various slope spectroscopy instruments, including interactive variable pathlength devices and related methods of use. C Technologies' scientists are continually developing new analytical tools using the company's slope spectroscopy technology, for which the company continues to file patent applications.

Proteins

The company holds a patent grant for 'Nucleic Acids Encoding Recombinant Protein A,' which claims sequences that encode a truncated recombinant Protein A but are otherwise identical to the natural Protein A, which is used for bioprocessing applications.

Pursuant to the company's collaboration with Navigo, the company also has multiple patent grants and multiple pending patent applications globally covering Protein A-based affinity ligands through the company's collaboration with Navigo. These include ligands for antibody purification, as well as ligands for purifying COVID-19 vaccines.

In addition, following the acquisition of Avitide in September 2021, the company continues to file multiple patent applications globally covering affinity ligands.

Trademarks

The company procures and maintains trademark registrations globally for the Repligen trademark and the company's various product brands. The company prioritizes its 'housemarks' (e.g., Repligen, the stylized 'R' logo, Spectrum, TangenX, C Technologies, ARTeSYN, Polymem, Avitide, Metenova, etc.), and ensures continued protection globally. The company also has trademark registrations for various product lines, including OPUS, XCell, XCell ATF, TFDF, KrosFlo, SIUS, ProConnex, Spectra/Por, NGL-Impact, SoloVPE, FlowVPE, FlowVPX, RPM, XO and AVIPure, that provide valuable company recognition and goodwill with the company's customers.

Licensing Agreements

The company has entered into multiple licensing and collaboration relationships with third-party business partners in an effort to fully exploit the company's technology and advance its bioprocessing business strategy. For example, the company entered into a 15-year exclusive License Agreement with Daylight (the 'Daylight Agreement'), giving the company exclusive license and commercialization rights to use certain technology and intellectual property subject to conditions set forth in the Daylight Agreement.

Competition

The company competes with Danaher Corporation (Pall Corporation and Cytiva), Thermo Fisher Scientific Inc., MilliporeSigma and Sartorius.

History

Repligen Corporation was founded in 1981. The company was incorporated in 1981 under the laws of the state of Delaware.