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Last updated: January 2026
This directory lists 54 single use bioprocessing manufacturers across the United States, from specialized bioreactor bag fabricators to complex fluid management system integrators.
Buyers engage these manufacturers to solve critical operational challenges, such as streamlining cell culture media preparation, enhancing sterility assurance for drug substance transport, or custom engineering solutions for challenging fill-finish operations. The demand often revolves around reducing cross-contamination risk, accelerating batch turnaround times, and minimizing cleaning validation requirements across various upstream and downstream bioprocessing steps.
The types of suppliers in this space vary significantly. Some are highly specialized, focusing exclusively on certain components like sterile connectors or sensor-integrated bags. Others are vertically integrated, offering comprehensive design, manufacturing, and validation services for entire single-use systems, including custom tubing sets, bioreactor assemblies, and buffer storage containers. Distinguishing factors include their in-house cleanroom capabilities, sterilization expertise, and ability to handle complex custom geometries.
Successful engagement requires buyers to arrive with clear, detailed specifications, including process flow diagrams, anticipated flow rates, pressure tolerances, and chemical compatibility requirements for all wetted materials. Manufacturers, in turn, expect transparency regarding target volumes, regulatory end-market requirements, and an openness to collaborate on design for manufacturability (DFM) feedback, which often significantly improves system performance and cost-effectiveness.
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54 companies nationwide
ABEC, Inc. provides customized process solutions and services for biopharmaceutical manufacturing, including vaccines, antibodies, recombinant proteins, and gene therapy. With 50 years of experience, the company delivers single-use systems, disposable containers, and stainless-steel equipment from its in-house capabilities.
Based in Southampton, PA, AdvantaPure manufactures high-purity tubing, hose, and custom single-use assemblies. Specializing in fluid transfer solutions for pharmaceutical and biopharmaceutical manufacturing, their products meet rigorous standards including ISO 9001:2015, USP Class VI, FDA, and European Pharmacopoeia.
Based in Bothell, WA, AGC Biologics is a global CDMO providing comprehensive development and manufacturing services. They specialize in protein-based biologics and advanced therapies, including cell, gene, and microbial solutions. The company supports projects from preclinical to commercial stages, offering rapid and efficient bioprocessing capabilities.
Alphinity LLC develops low-shear, single-use valves, pumps, check valves, and bespoke fluid control systems for modern bioprocessing. Their solutions protect sensitive biologics, improve handling accuracy, and support scalable workflows from process development through GMP manufacturing. They serve upstream and downstream operations for cell therapies, monoclonal antibodies, and advanced biologics.
Saint-Gobain Biopharm manufactures fluid transfer assemblies designed for biopharmaceutical applications. These single-use components provide safe and efficient fluid handling in critical process environments. They offer specialized solutions supporting drug discovery, development, and manufacturing for the biotechnology industry.
Brevet specializes in custom fluid path engineering, manufacturing connectors, adapters, and reducers from polycarbonate and PVC. Serving the BioPharma, Medical, and Dental sectors, the company provides application-specific connection solutions engineered for critical performance and purity. All products are 100% American made and assembled.
Broadley-James Corporation, based in Irvine, CA, manufactures single-use sensors for bioprocess applications. Their SG300 and SU600 series offer pre-calibrated, irradiated pH, DO, and pCO2 measurement solutions. Designed for integration into bioprocessing containers, these sensors streamline critical monitoring in biopharmaceutical manufacturing.
Chemglass Life Sciences, through its CG Biosciences division, manufactures single-use bioprocessing products. They provide media bottle assembly systems, PETG components, and Advantaflex/C-Flex tubing for transfer and feed applications in bioprocessing. The company operates a production campus with dedicated facilities.
D&D Filtration specializes in providing 3D bioprocess bags for critical bioprocessing applications. These bags are designed for the containment of sterile media, cell cultures, sera, buffers, and reagents. The company offers essential filtration and containment solutions, supporting the biopharmaceutical industry with specialized single-use products.
Eldon James Corporation manufactures single-use plastic components, PVC-free tubing, quick disconnects, and assemblies. They provide fluid handling solutions for medical devices, life sciences, bioprocess, biomedical, and pharmaceutical applications. ISO 9001 and ISO 13485 certified, the company processes advanced USP Class VI medical polymers.
Eppendorf manufactures BioBLU Single-Use Bioreactors, offering rigid-walled, stirred-tank solutions for bioprocessing applications. They also provide a broad range of laboratory equipment and consumables, including pipettes, workstations, and bio-based tubes and plates designed for scientific research and lab connectivity.
Foxx Life Sciences, based in Salem, NH, manufactures single-use systems and technology for the bioprocessing, pharmaceutical, and biotech industries. They provide a range of single-use products, including custom solutions, bottle and carboy assemblies, and filtration, all manufactured with USP Class VI materials in ISO Class 7 cleanrooms.
Based in West Sacramento, CA, GeminiBio manufactures critical bioprocessing solutions for the global biotechnology industry. With cGMP facilities, they specialize in custom buffers, media hydration, high purity water (WFI quality), human serum AB, and FBS, optimizing cell culture and process liquid workflows for biopharma, gene, and cell therapy applications.
HPNE offers bioprocess solutions and products for the biopharmaceutical industry, spanning discovery to commercial launch. They specialize in single-use assemblies, including customizable HPConnexx™ systems, sterile individually packaged components, and various single-use and multi-use sensors. The company also provides media and buffer storage solutions.
Instant Systems manufactures FlowLoc™ tubing sets and inline filters, providing secure, sterile solutions for critical bioprocessing applications. Their single-use components are designed to support cell therapy manufacturing and ensure closed system transfers, meeting the rigorous demands of the pharmaceutical and biotech industries.
B. Braun manufactures single-use fluid transfer sets and related medical devices within cleanroom environments. The company offers components like vented spikes and dispensing solutions, designed for efficient and sterile fluid handling in healthcare and bioprocessing applications, supporting diverse medical and pharmaceutical needs.
Based in Sun Valley, CA, International Filter Products specializes in pharmaceutical-grade filtration and bioprocessing solutions. They provide sterile, single-use bags engineered for the storage and transfer of media, buffers, and biological products. The company offers advanced filtration technology for diverse drug development areas.
Based in Camarillo, CA, Meissner Filtration Products, Inc. manufactures single-use systems and filtration products for life sciences. They provide TepoFlex® biocontainers for freeze & thaw, microfiltration, stainless steel housings, and aseptic transfer solutions. Meissner focuses on engineered excellence and automation for critical bioprocessing applications.
Nest Scientific USA manufactures single-use bioprocessing products and aseptic transfer systems for laboratory and industrial applications. Based in Woodbridge, NJ, the company provides sterile, contamination-free solutions including single-use bioreactors, bioprocess bags, filtration products, and tubing. They support critical biopharmaceutical research and production processes.
Based in Austin, TX, OriGen Biomedical specializes in manufacturing innovative single-use disposables. The company focuses on products for cryopreservation and cell culture applications, designing solutions to improve patient health. OriGen Biomedical maintains ISO 13485 and MDSAP certifications for quality.
Pristine Clean Bags manufactures FDA and EU-compliant cleanroom poly bags, tubing, and films from virgin, non-animal origin, surfactant-free materials. Operating in a certified controlled environment, they provide sterile and nonsterile products for medical and high-purity industries, including essential components for single-use bioprocessing.
Quattroflow, a brand within the PSG family, manufactures specialized single-use pumps for the biotech and pharmaceutical industries. These pumps feature disposable plastic pump chambers, designed to meet high-purity demands and strict regulatory requirements for critical applications, from laboratory to commercial scale bioprocessing.
Based in Northampton, MA, Purity One manufactures fully customizable single-use tubing, manifold solutions, and lab-scale modular mixing systems. These critical components are designed for precision performance and scalability, contributing to improved quality of life and wellness across various applications, including bioprocessing.
Based in Ronkonkoma, NY, Qosina is a global supplier of OEM single-use components for the medical and pharmaceutical industries. They provide thousands of stock components, including clamps, connectors, and valves, essential for bioprocessing applications. Qosina's facility is ISO 13485 and ISO 9001 certified, ensuring quality for their manufactured products.
Resilience is a biomanufacturing Contract Development and Manufacturing Organization (CDMO) delivering end-to-end solutions for complex medicines. Based in San Diego, CA, the company focuses on safe, scalable, and reliable manufacturing of therapeutics for its partners. Resilience aims to improve access to essential medicines through excellence and quality.
Based in Camarillo, California, SaniSure manufactures single-use technologies (SUT) and custom assemblies for complex flow paths in bioprocessing and advanced therapies. The company produces engineered components and proprietary solutions including mixing, filling, and cell culture systems, serving pharmaceutical and biotechnology clients.
Superior Sensor Technology manufactures high-accuracy pressure sensors with features like extreme resolution and multi-range technology. Their products monitor critical variables in medical, HVAC, and industrial applications, including filtration systems, bioreactors, and process vessels. These sensors are vital for maintaining optimal conditions within bioprocessing and other advanced industrial systems.
TBL Performance Plastics manufactures non-metallic single-use products for bio-pharmaceutical and drug development companies, including CMOs. They offer tubing, fittings, custom single-use assemblies, and media bottles. Specializing in various polymeric materials, they also provide injection molding, private labeling, and prototyping services.
Tezalon, based in Bakersfield, CA, provides state-of-the-art automation-ready bioprocess systems and single-use solutions for the biotech industry. Specializing in single-use mixers and modular TFF benchtop systems, they support upstream and downstream bioprocesses from lab to commercial production, offering engineering and automation services.
Based in Carlsbad, CA, Vista Biologicals provides specialized cell culture and biologics manufacturing services. The company offers end-to-end support from early-stage design to scaled GMP production, including process development, upstream/downstream processing, and comprehensive pharmaceutical testing. They serve biotech and biopharmaceutical clients.
Based in Trevor, WI, Vonco Products, LLC manufactures single-use bioprocessing bags, fluid bags, and custom flexible packaging solutions. The company offers comprehensive services from concept to commercialization for medical devices and critical containment, serving bioprocessing and medical markets with US-made products.
Automated Engineering Services, Inc. (AES) manufactures single-use bioprocessing solutions for the biotech industry, supporting processes from lab-scale to commercial manufacturing. They offer advanced equipment like the AES BioMix, a single-use mixer with a bottom-mounted magnetic drive agitator for precise and efficient mixing control.
WuXi Biologics is a global Contract Research, Development, and Manufacturing Organization (CRDMO) for biologics. With cGMP facilities in the United States and worldwide, the company exclusively uses single-use/disposable bioreactors. They offer extensive R&D and manufacturing services, supporting clients from target discovery to commercial production.
Ace Sanitary manufactures custom single-use tubing assemblies for sanitary and high-purity liquid transfer solutions. The company provides single-use assemblies, bulk silicone tubing, sanitary process hoses, and pharma gaskets, serving various industries with no minimum order quantity.
Based in Torrance, CA, Axiom Medical specializes in custom silicone tubing and extrusion services. They manufacture silicone components to stringent medical quality standards, including MDSAP/ISO 13485, FDA, and CE certifications. All products are made entirely in the USA.
Based in Winston-Salem, NC, Charter Medical provides scalable single-use solutions for advanced bioprocessing, cell and gene therapy, and cryopreservation. The company offers a range of products including fluid transfer bags, cell expansion containers, and cryogenic storage containers, along with customization services.
CPC (Colder Products Company) designs and manufactures quick connect and disconnect fluid couplings, fittings, and connectors. These specialized fluid management components are essential for bio, medical, and industrial applications, directly supporting single-use bioprocessing needs.
Critical Process Filtration manufactures high-performance filters and purification products for critical applications, primarily in the pharmaceutical and biopharmaceutical sectors. Based in Las Cruces, NM, the company specializes in single-use filter capsules and sterile grade filtration solutions, providing essential components for bioprocessing systems.
Entegris manufactures customizable single-use solutions for bioprocessing applications, including cell growth, separation, mixing, and storage. They provide high-purity solutions for upstream, downstream, and fill/finish operations, supporting cell and gene therapy as well as oligonucleotide production.
Based in Farmington, CT, Mott Corporation specializes in filtration and flow control engineering. The company provides advanced solutions for diverse industries including healthcare, microelectronics, and chemical processing. They manufacture critical components, potentially including single-use bioprocessing filters, leveraging over 60 years of expertise in complex engineering challenges.
Sani-Tech West, based in Camarillo, CA, designs, develops, and manufactures single-use solutions for the bioprocessing industry. Founded in 1991, the company provides specialized components and assemblies, supporting pharmaceutical and biotech manufacturing with high-quality, sterile products for critical applications.
Sealed Air manufactures specialized Nexcel BIO1250 bioprocessing film, engineered for critical bioprocessing applications. With a legacy in advanced packaging, the company provides innovative materials and solutions across various industries. They also offer a wide range of food safety and protective packaging products.
Abzena is a biopharmaceutical CDMO and CRO based in Seattle, WA. The company provides fully integrated drug design, development, and GMP manufacturing services for biologics and bioconjugates. They utilize single-use technology in their manufacturing facilities for rapid turnaround and cost-effective solutions.
Based in Yorba Linda, CA, Aseptic Technology LLC provides aseptic processing solutions for life science, biotech, pharmaceutical, and medtech industries. They specialize in innovative ready-to-use devices, including their AT-Closed Vial® system, offering device design, injection molding, and packaging to support advanced therapies.
Based in Radnor, PA, Avantor is a global provider of mission-critical products and services for the life sciences and advanced technologies industries. The company specializes in manufacturing single-use bioprocessing mixing systems designed for liquid-liquid or solid-liquid applications, offering tailored solutions for production needs.
Boehringer Ingelheim operates a plant in the San Francisco Bay Area, offering flexible cell culture and purification trains for large-scale biopharmaceutical contract manufacturing. They specialize in comprehensive biopharmaceutical production services, leveraging advanced technologies to support diverse client requirements.
Carr Biosystems pioneers advancements in bioseparations by manufacturing the UniFuge® family of single-use separation systems. These centrifuges accelerate the production of high-quality biological products and medicines, minimizing contamination risk. Their scalable solutions deliver high product recovery for critical bioprocessing applications.
Cytiva is a global life sciences leader that manufactures single-use bioprocessing systems, including bioreactors, for pharmaceutical and biotechnology companies. They provide advanced solutions to optimize cell cultures, enhance process speed, and ensure flexibility in biopharmaceutical manufacturing workflows.
Donaldson Life Sciences, headquartered in Bloomington, MN, manufactures advanced single-use bioprocessing solutions. They provide critical fluid management and filtration components, systems, and custom assemblies for various stages of biomanufacturing. Their expertise supports aseptic processing and ensures efficient production for biopharmaceutical clients.
Freudenberg Medical is a contract design and manufacturing organization (CDMO) specializing in medical devices and pharmaceutical innovations. The company designs and builds single-use assemblies for critical bioprocessing applications, leveraging expertise in silicone and thermoplastic extrusion.
ILC Dover, based in Frederica, DE, manufactures single-use flexible containment solutions for the biopharmaceutical industry. They offer bioprocess containers, bags, and assemblies for sterile fluid transfer, sampling, and cell culture. These products are engineered to enhance safety, maximize efficiency, and reduce sterilization needs in critical bioprocessing workflows.
LePure Biotech LLC provides high-performance single-use technologies and integrated bioprocessing solutions for the biopharmaceutical industry. They offer advanced film and bag assemblies, fluid management components, equipment, and validation services to accelerate drug development and reduce costs.
Based in Branchburg, NJ, Repligen specializes in manufacturing innovative, designed-for-purpose storage and transfer solutions for fluid management within bioprocessing unit operations. They provide essential components that enhance efficiency and safety in single-use biomanufacturing workflows, serving the life sciences industry.
Thermo Fisher Scientific provides innovative single-use technologies to accelerate biological manufacturing processes. The company offers solutions that enhance flexibility and dynamic operations for biopharmaceutical production, including essential bioprocessing components and antibodies for various applications.
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You should expect comprehensive extractables and leachables (E&L) data for all wetted materials, ideally generated using BioPhorum Operations Group (BPOG) protocols. This includes studies performed on final components after sterilization (e.g., gamma irradiation), using relevant solvents and temperatures. Manufacturers should provide data on organic and inorganic extractables, and ideally, have toxicology assessments or risk analyses for potential leachables. Ensure they can trace material lots back to the raw polymer resin and provide consistent data across different batches.
Ensuring sterile connections relies on two main factors: the design of your single-use system and the manufacturer's component selection and assembly practices. Reputable manufacturers utilize validated sterile connectors (e.g., genderless sterile tube welders or quick-connect devices) and assemble tubing sets in an ISO-classified cleanroom environment. Post-assembly, the entire system often undergoes gamma irradiation for terminal sterilization. It's crucial to verify the manufacturer's validation data for their welding processes and the compatibility of their chosen sterile connectors with your specific fluids and process parameters.
The most common sterilization method for single-use bioprocessing components is gamma irradiation, followed by autoclaving (for components designed to withstand heat) and less commonly, ethylene oxide (EtO). For gamma irradiation, look for a sterility assurance level (SAL) of 10^-6, which means a one in a million chance of a non-sterile unit. The manufacturer must provide Certificates of Conformance (CoCs) for each lot, detailing the dose administered and date of sterilization. Ensure they have documented dose mapping studies, dose audit data, and can demonstrate no significant material degradation or E&L profile changes at the validated dose range.
Choosing between custom and off-the-shelf depends heavily on your process maturity and specific needs. Off-the-shelf solutions are generally faster to procure, more cost-effective for smaller volumes, and come with existing validation packages, making them ideal for early-stage R&D or less complex processes like buffer preparation. Custom designs become essential for complex bioprocesses, such as specific bioreactor configurations, unique sampling manifold assemblies, or highly integrated fluid management systems for aseptic fill-finish. They allow for optimized flow paths, specialized sensor integration, and precise scalability, but require longer lead times, higher upfront engineering costs, and extensive validation.