Bioprocess, Unbottled

Single-use systems (SUS) have become a transformative force in biopharmaceutical processing, offering an alternative to traditional stainless-steel equipment. These disposable, pre-sterilized technologies—encompassing bioreactors, mixing containers, filtration assemblies, and more—bring significant benefits: reduced contamination risk, faster batch changeovers, greater flexibility, and lower upfront facility costs. In the wake of the COVID-19 pandemic, the adoption of SUS accelerated as manufacturers sought rapid, agile production solutions for vaccines and therapeutics. Today’s single-use innovations span the entire bioprocess workflow, from cell culture to purification to final fill, and are propelling faster drug development and production.

This article explores the latest trends and technological advancements in single-use bioprocessing, with a spotlight on key industry players driving innovation. We compare how major global suppliers like Danaher’s Cytiva and Pall, Thermo Fisher Scientific, Sartorius, Merck MilliporeSigma, and Japan’s SATAKE MultiMix are pushing the boundaries of SUS design. We also examine the rise of Chinese single-use leaders – LePure Biotech, JYSS Bio-Engineering, Tofflon, Duoning Biotechnology, and AUSTAR – who are rapidly expanding domestic capabilities. Key areas of focus include single-use bioreactors (SUBs), mixing systems, bag assemblies, filtration technologies, and integrated production platforms. We will also discuss regional strengths (notably China’s growing SUS ecosystem), GMP/regulatory considerations, sustainability initiatives, and how these innovations are accelerating biopharma manufacturing.

The Rise of Single-Use Technology in Bioprocessing

Single-use technology has moved from a niche option to the mainstream across upstream and downstream bioprocessing. Early uses in the 1980s–1990s were limited to filters and small disposable bags, but the late 1990s saw the advent of large-scale single-use bioprocess bags up to ~1,000 L. By around 2010, SUS evolved from “support systems” (e.g. media bags) to “production systems”, capable of handling full commercial manufacturing processes. Today, disposable bioreactors up to 2,000 L volume are industry-standard, and even larger single-use reactors are emerging, breaking the perceived size ceiling of SUS. Entire production suites can be configured with modular single-use equipment, enabling end-to-end continuous processing in some cases.

Key drivers of SUS adoption include the reduction of cross-product contamination risk (each batch uses a new sterile flow path) and elimination of time-consuming clean-in-place/steam-in-place (CIP/SIP) procedures. Single-use components allow quick changeover between products, which is invaluable for multi-product facilities and rapid clinical scale-up. The flexible, plug-and-play nature of SUS means biomanufacturers can scale up or down by swapping out bag sizes or reactors, meeting varying demand with relative ease. This has democratized manufacturing capacity – even smaller companies or CMOs can set up agile production lines without investing in large fixed stainless infrastructure.

At the same time, challenges have driven further innovation. Historically, concerns included material compatibility, extractables/leachables from plastics, waste generation, and supply chain dependence on a few film/bag suppliers. The COVID-19 experience underscored supply vulnerabilities: heavy reliance on imported single-use bags and components led to shortages and delays. This, in turn, spurred investments in local manufacturing and new suppliers – particularly in regions like China – to ensure a more resilient supply of SUS consumables. Environmental sustainability is another pressure: while SUS saves water and energy by avoiding cleaning, it generates plastic waste that is usually incinerated. As we will see, the industry is actively seeking solutions such as recyclable materials and take-back programs to improve the lifecycle impact of single-use technology.

Overall, single-use systems are now a cornerstone of modern biopharma facilities. The following sections detail how leading companies are advancing SUS design and overcoming challenges in upstream (fermentation/cell culture) and downstream (purification, formulation) processing.

Upstream Processing: Advances in Single-Use Bioreactors and Mixing Systems

Single-use bioreactors (SUBs) have seen remarkable innovation in recent years, targeting larger scales, better performance, and specialized applications. The standard SUB design is a stirred-tank disposable bag in a steel support container, typically up to 2,000 L working volume. Companies like Sartorius, Thermo Fisher, Cytiva (Danaher), and Merck MilliporeSigma have long offered SUB lines in this range. The push now is to go beyond the 2,000 L limit and to improve mixing, oxygenation, and process control to match or exceed stainless-steel performance.

ABEC’s giant SUBs: One notable pioneer is ABEC, which has systematically broken the “volume ceiling” for SUBs. While most vendors stopped at ~2,000 L, ABEC introduced a 4,300 L (3,500 L working volume) single-use bioreactor in 2015, followed by a 4,900 L system (4,000 L working) in 2017. By 2019, ABEC launched a 6,000 L disposable bioreactor – three times the industry’s standard upper limit. These Custom Single Run (CSR) bioreactors achieve cell culture performance comparable to stainless steel, enabling unprecedented economies of scale for high-volume products. Leading manufacturers have already been operating ABEC 4,000 L SUBs (double the usual size), and the 6,000 L systems set new benchmarks in lowering cost of goods for commercial biologics. For example, a China-based CDMO, BioInno, installed the first 6,000 L SUBs to gain multi-product flexibility with low cost-per-batch for monoclonal antibodies. ABEC’s engineering of huge, robust single-use bags and integrated mixers demonstrates that scale-up limitations are being overcome, extending single-use into production volumes once thought impractical.

Thermo Fisher Scientific has similarly expanded SUB capacity with its HyPerforma DynaDrive bioreactor series. Thermo launched 3,000 L and 5,000 L single-use stirred-tank reactors, claiming the first 5,000 L SUB on the market. Unveiled in 2020 and now deployed globally, the DynaDrive 5,000 L reactors feature improved mixing and mass transfer to handle large volumes effectively. Thermo Fisher also recently introduced a 5 L benchtop DynaDrive unit that is geometrically consistent with the large vessels, enabling truly seamless scale-up from 1 L process development scale to 5,000 L manufacturing scale. This uniform design across scales ensures that parameters like oxygen transfer, cell growth, and product yield remain consistent from lab to production, greatly streamlining tech transfer. Notably, the new 5 L system boosted lab productivity by 27% compared to traditional glass bioreactors, by shortening cycle times and enabling more experiments per year. This illustrates how single-use platforms can accelerate process development timelines. Thermo’s DynaDrive also incorporates sustainable features: its disposable Aegis™ 5-14 film is made from bio-based feedstock with net-negative carbon emissions, and BioTitan™ bag retention devices reduce packaging waste and shipping damage. These innovations tackle two typical weak points of SUBs – environmental footprint and risk of leaks or failures when handling large, heavy bags.

Mixing technology is another critical area of upstream innovation. Properly dissolving powders (like culture media) and achieving homogeneous mixing at large scale can be challenging for single-use mixers. In April 2024, Cytiva (Danaher) showcased its new Xcellerex™ compact single-use magnetic mixer at INTERPHEX, designed specifically for high-volume media and buffer prep. Available in 2,000 L and 3,000 L sizes, this mixer addresses two major pain points: leakage and slow dissolution. The unit features a novel mixer biocontainer with user-centric design improvements to prevent leaks during shipping and operation – a minor leak in a 3,000 L media batch could cost $60k–$100k in lost product. Cytiva engineered a more durable bag and connection system with added safeguards against punctures or strain. Additionally, the Xcellerex mixer’s container has a unique hexagonal shape and a powerful impeller. This combination creates a strong vortex that actively pulls floating powder down into solution, drastically improving the mixing of hard-to-wet powders like cell culture media. By shortening mix times and ensuring complete dissolution, it avoids delays in upstream operations. Cytiva notes that traditional single-use mixers often had underpowered impellers and suboptimal geometry for large volumes – the new design directly tackles those limitations. The mixer is also compact for easier installation in facilities with space constraints.

SATAKE MultiMix, a Japanese company with deep roots in mixing technology, has taken a different approach to single-use bioreactor mixing. SATAKE’s SUB designs (50 L up to 200 L, with 1,000 L in development) employ a proprietary linear motor-driven mixing shaft (a reciprocating motion) instead of the conventional rotating impeller. This vertical oscillation system, combined with specialized impellers, achieves efficient mixing and oxygen transfer while eliminating shaft seals. The result is robust mixing with reduced shear and low risk of contamination. SATAKE’s VMF-series single-use bioreactors are notable for being locally manufactured in Japan, including the bags. In fact, SATAKE emphasizes its 100% domestic supply chain for single-use bags and impellers, allowing just-in-time supply of small lots of bags as needed. This strategy ensures Japanese biomanufacturers are less vulnerable to global supply disruptions, a lesson learned during COVID-19 when overseas bag supply became a bottleneck. SATAKE’s single-use bags are delivered pre-sterilized and ready to use, fabricated from USP <VI>-compliant materials, and incorporate features like an integrated Thermo Fisher sensor port and optional single-use pressure sensor. By combining unique mixer engineering with local production, SATAKE MultiMix is tailoring SUS bioreactors to meet regional needs for scalability and security of supply.

Sartorius has been another leader in SUBs, focusing on improving cell culture intensity and process analytical technology (PAT). In 2023, Sartorius launched an integrated intensification system by incorporating Repligen XCell ATF perfusion devices into its Biostat STR single-use bioreactors. This built-in cell retention module enables straightforward implementation of N-1 perfusion or full perfusion culture for users, without the complexity of external cell-separation setups. The embedded ATF drives higher cell densities and productivity while maintaining a closed, single-use flow path. Sartorius provides pre-defined control recipes and PAT integration for the perfusion module, helping users adopt continuous upstream processing more easily. As Sartorius notes, this innovation demonstrates their commitment to process intensification – enabling clients to produce more therapeutics faster by running smaller bioreactors at higher efficiency. It also aligns with the industry trend toward continuous biomanufacturing. Sartorius’s SUB portfolio (Biostat STR, Ambr®, etc.) covers scales from tiny 15 mL microbioreactors up to 2,000 L production, and the company’s Flexsafe® family of single-use bags is known for its robustness across that range. The Flexsafe® film was developed to withstand extensive agitation, flexing and long culture durations, thereby minimising risk of film failure or leachables even in intensive processes. Sartorius has also introduced specific SUB variants for cell and gene therapy (e.g. the Biostat RM TX rocking bioreactor for T-cells) to cater to emerging modalities.

In summary, upstream single-use technologies are advancing on multiple fronts: scale-up (larger volumes), scale-down (high-throughput microscale), mixing efficiency, and intensification (perfusion and high cell density). The major suppliers are each contributing: ABEC with scale, Thermo Fisher with scalable design and sustainable films, Cytiva with user-focused mixing and global supply expansion, Sartorius with integrated perfusion and high-performance films, and SATAKE with novel mixing mechanics and local supply. Meanwhile, newer entrants such as China’s JYSS Bio-Engineering are innovating unique bioreactor designs – for instance, JYSS’s patented CUR series SUB employs a “non-bubbling interfacial oxygen transfer” mechanism that achieves high k_La without sparging, thereby avoiding cell damage from bubbles and excessive shear. This kind of inventive engineering broadens the toolkit of single-use bioreactors to address specific cell culture challenges (e.g., shear-sensitive cell lines). All these developments are making single-use upstream systems more capable, reliable, and suited for an even wider range of bioprocesses.

Downstream Processing: Single-Use Filtration and Purification Assemblies

While upstream SUBs often steal the spotlight, single-use technology has also revolutionised downstream processing. Filtration, purification, and fluid transfer steps can now be executed with disposable flow paths that maintain sterility and reduce hold-up volumes. Key components include single-use depth filters, sterile connectors, virus filters, TFF (tangential-flow filtration) cassettes, chromatography skids with disposable tubing manifolds, and pre-assembled tubing/bag manifolds for buffer and product handling.

Filtration systems: Danaher’s Pall corporation (now integrated under Cytiva) and Sartorius are giants in filtration. Pall’s traditional strength in filters has evolved into fully disposable filter modules and automated single-use TFF systems. For example, Pall (Cytiva) offers Allegro™ 2D and 3D biocontainer systems for product storage that boast extremely low extractables, high chemical compatibility, and compatibility with single-use filter assemblies. These were originally Pall products and now part of Cytiva’s portfolio after Danaher’s integration of Pall Life Sciences in 2023. Merck’s MilliporeSigma unit likewise provides an extensive range of filters and has developed entire single-use downstream units. Merck’s Mobius® single-use assemblies cover sterile filters, virus removal filters, and ultrafiltration cassettes integrated into disposable tubing sets. The Mobius 2D and 3D bag assemblies (50 mL up to 200 L) are often paired with Merck’s filters for tasks like sterile media and buffer preparation or product bulk storage. Merck leverages its long history in membrane technology (dating back to the Milipore pioneers of microporous filters) to assure these single-use filters meet high quality and regulatory standards. For instance, Merck’s NovaSeal™ sealing technology on Mobius bag ports ensures robust hermetic seals that prevent leaks during filtration operations. Furthermore, single-use filter capsules (e.g. for depth filtration of cell harvests) have enabled quicker turnaround between batches; they are simply discarded after use, eliminating the extensive cleaning validation needed for re-useable housings.

Chromatography: Traditionally, chromatography columns have been stainless steel and re-used, but single-use solutions are emerging here too. Pre-packed disposable chromatography columns (up to 30 cm or so in diameter) are available for certain resins, which can be used for a campaign and then discarded, saving cleaning and packing time. Sartorius and Cytiva have both introduced single-use flow paths for chromatography skids. For example, Sartorius offers single-use flow kits on its ÄKTA systems (via Cytiva technology) or its own chromatography systems, where all tubing, valves, and even gradient mixers contacting the product are disposable. Continuous chromatography (multi-column set-ups) also pairs well with single-use valves and tubing, since the system configuration can be complex but is pre-configured and sterilized by the vendor.

Merck’s BioContinuum™ Platform exemplifies the push toward next-gen downstream. It includes single-pass TFF devices (Pellicon® capsules) for continuous concentration, and a newly developed single-use flow-through polishing system (co-developed with Transcenta in China) to enable continuous purification of mAbs. This indicates how single-use components are key to realising continuous downstream processes, often termed “contiGuous” bioprocessing by Merck. The integrated single-use assemblies in these platforms simplify what would otherwise be complex piping of different unit operations.

Bag assemblies and connectors: Single-use bag assemblies are the unsung heroes in downstream and formulation steps. Companies like LePure Biotech (China) have specialised in high-quality bioprocess bag fabrication. LePure’s LeKrius® film, for instance, is a five-layer co-extruded film the company produces in-house to ensure supply continuity. They offer 2D and 3D bags from 5 mL to 3,000 L, with tailored designs for applications like powder transfer (e.g. anti-static bags for powder media). Single-use bags are used to mix and hold buffers, collect column fractions, and store drug substances (often in refrigerated or frozen state). Specialized assemblies such as single-use mixing bags with built-in impellers (e.g. from Duoning’s DuoMix® line) allow downstream mixing of formulations or adjustment of pH in a closed system. Critical to all these are sterile connectors and disconnectors (from suppliers like CPC or Pall) which allow sterile fluid transfers between bags, filters, and processing units. Many vendors now provide pre-assembled manifolds: for example, a complete single-use TFF loop can come gamma-sterilized with pump tubing, filters, reservoirs, and sensors all connected. This reduces on-site assembly errors and shortens set-up time. Chinese companies have also developed these capabilities – Duoning Biotech produces a wide range of single-use tubing sets, connectors, and even a single-use bulk filling system (DuoFill) for final drug product dispensing. Duoning’s portfolio even includes a single-use PUPSIT (pre-use post-sterilization integrity test) assembly that helps users comply with EU regulatory guidelines by enabling sterile in-line filter integrity testing. By offering such ready-made solutions, single-use suppliers simplify compliance with GMP steps in downstream processing.

Filtration capacity is another area seeing expansion. In response to surging demand for filters (especially during the pandemic for vaccine production), Cytiva/Danaher has been investing heavily in manufacturing capacity. Cytiva is boosting its filter membrane production by over 30% in places like Puerto Rico and the UK. Notably, Cytiva’s new manufacturing lines are stocking standard single-use consumables (like commonly used bag and filter sizes) on the shelf for immediate delivery, aiming to shrink lead times for customers. This reflects a broader trend: as single-use becomes business-critical, suppliers are focusing on supply chain reliability and localised production “in-region, for region” to avoid the delays and freight issues seen in the past. Pierre-Alain Ruffieux, Cytiva’s COO, highlighted that producing consumables closer to end-users not only speeds delivery but also reduces carbon footprint and mitigates risks from trade restrictions. Indeed, Cytiva tripled capacity at its Chinese joint venture facility in 2021 (with Wego in Beijing) to supply Asia-Pacific with single-use consumables. Similarly, Sartorius, Thermo and Merck have all added production sites in Asia or increased output in existing plants to support regional markets. The downstream implication is that filters and single-use assemblies should become more readily available and less of a bottleneck for biologics manufacturing.

In summary, single-use downstream innovations focus on ready-to-use, integrated assemblies that reduce manual operations and ensure sterility, from clarification to final fill. The major players – Cytiva/Pall, Sartorius, Merck, Thermo – each offer end-to-end disposable solutions: e.g. Cytiva’s Allegro platform (from Pall) provides biocontainers and filters for every step, Sartorius has its Flexsafe film bags, membrane filters, and even single-use centrifugation options, and Merck integrates Mobius bags with its best-in-class filtration tech. Importantly, new entrants like LePure and Duoning are expanding the supplier base for bags, filters, and connectors, often with cost-effective offerings and faster lead times in local markets. This diversification of suppliers improves robustness of the single-use supply chain, benefiting downstream operations that depend on consistent consumable availability.

Integrated Single-Use Production Platforms

One of the most powerful advantages of single-use systems is the ability to create integrated, turnkey production platforms. Rather than constructing traditional facilities with fixed tanks and piping, companies can now implement modular factories built around single-use skids for each unit operation. These can be designed, tested, and even pre-fabricated by the supplier and delivered for rapid on-site assembly. The result is faster facility deployment, scalable capacity, and easier reconfiguration when process needs change.

Danaher’s Cytiva has been a pioneer in this approach with its FlexFactory™ platform. A FlexFactory is essentially a configurable biomanufacturing suite composed of single-use bioreactors, mixers, separations, and filling systems, all tied together with an automation and logistics framework. Cytiva has deployed FlexFactory units worldwide for modalities ranging from mAbs to vaccines to cell therapies. For example, AGC Biologics installed Cytiva FlexFactory suites in Yokohama to manufacture mRNA vaccines, achieving startup in under 16 months. In China, Ribobay Pharma recently adopted a FlexFactory for oligonucleotide API production, showing the platform’s versatility beyond classic proteins. The appeal is that the entire process flow – seed train, production bioreactor, clarification, chromatography, buffer prep, etc. – is designed as a coordinated single-use system. This minimizes interfaces between steps and ensures compatibility. Cytiva also offers KUBio, a related concept where a complete GMP facility (including cleanroom structure) is delivered as modules along with single-use equipment. Such solutions have helped biopharma companies add capacity in new regions quickly and with lower capital expenditure. Notably, FlexFactory and KUBio installations in countries like China, Poland, and Brazil have broadened local biomanufacturing capabilities by providing a ready-to-run “factory in a box” that meets international GMP standards.

Chinese suppliers have likewise embraced modular single-use facilities. Tofflon, traditionally known for lyophilizers and fill-finish equipment, has developed a comprehensive offering of modular bioprocess units. Tofflon can deliver modules for upstream (various single-use bioreactors: wave, magnetically stirred, top-driven or bottom-driven – essentially any configuration a client needs) as well as downstream and formulation modules. At the Biologics Manufacturing Asia 2025 conference, Tofflon showcased its Modular Facility concept, which integrates single-use bioprocess equipment with cleanroom modules, aseptic filling, and even AI-driven automation. The benefit is rapid deployment and scalability – standardized modules can be added or removed to scale capacity, and the entire facility is designed for regulatory compliance from day one. Tofflon’s success in this arena was highlighted when it won the 2025 Asia-Pacific Biopharma Excellence Award for Best Bioprocessing Supplier (Single-Use Consumables), reflecting its leadership in improving the regional supply chain and manufacturing infrastructure. By combining single-use systems with modular construction, Tofflon and others enable biomanufacturers to go from concept to functional plant in a fraction of the time of a conventional build.

AUSTAR (based in Hong Kong/China) is another integrator providing end-to-end solutions. AUSTAR leverages its ability to design and manufacture both stainless steel and single-use systems to deliver customised hybrid facilities where appropriate. This is useful for processes that might benefit from a mix (for instance, a stainless steel seed bioreactor feeding a single-use production reactor, or stainless steel chromatography columns in tandem with single-use buffer bags). AUSTAR’s philosophy is to tailor the solution to the client’s process and investment needs, achieving the optimum balance of flexibility and cost. Their scope covers consulting, design, fabrication, and validation services, ensuring the final setup meets GMP requirements. They pay particular attention to regulatory compliance in the design phase and perform thorough documentation and verification following Good Engineering Practice (GEP) and GDP (Good Documentation Practice). This focus is crucial because when deploying many single-use units together, one must consider holistic validation (e.g. ensuring all single-use components are qualified, and that the integration doesn’t introduce contamination risks). AUSTAR even offers services like system risk assessment for single-use adoption and materials compatibility testing as part of their project delivery. Such support helps end-users navigate the GMP implications of disposable technology, which differ from those of fixed systems.

All told, integrated platforms are turning biomanufacturing into a more turnkey and flexible enterprise. Whether via Cytiva’s ready-made suites, Tofflon’s modular factories, or AUSTAR’s bespoke hybrid systems, the idea is to shorten project timelines and de-risk the scale-up of new therapies. For rapidly growing sectors like cell and gene therapy, this is enabling companies to get manufacturing online in time to meet clinical and early commercial needs. It’s also leveling the field globally – countries that lacked biologics infrastructure can now import modular single-use facilities to jump-start local production. As a result, we see a decentralization of biomanufacturing, with single-use technology at its core.

China’s Emergence as a Single-Use Technology Powerhouse

A decade ago, the single-use market was dominated by US and European firms. Today, China has rapidly risen as both a major consumer and producer of SUS for biopharma. The Chinese biopharma boom – with hundreds of new biologic developers and CMOs – created massive demand for single-use equipment, much of which was initially imported. However, Chinese companies have capitalized on this opportunity to develop their own SUS products, supported by government initiatives for biomanufacturing self-reliance and by tech transfers from global partners.

LePure Biotech is one of China’s leading domestic SUS providers. Founded in 2011, LePure has built a broad portfolio of single-use bags, assemblies, and even bioreactors (branded LePhinix® SUB). A distinguishing strength of LePure is its vertical integration into film production – it formulated its own polyethylene multi-layer film and established film extrusion facilities in-house. By controlling film quality and supply, LePure alleviates the shortages that can arise when relying on overseas film sources. Its LeKrius® film-based bioprocess containers cover volumes from lab scale to 2,500 L, and are designed for compatibility across platforms. LePure’s bag portfolio includes 2D storage bags, 3D large tote liners, mixing bags, and specialty bags (for cryopreservation, powder addition, etc.). The company also produces sterile connectors, tubing (TPE and silicone under Le-Flex® brand), and even its own filter capsules (PES, PVDF membrane filters under LeSiever® line). Essentially, LePure offers an end-to-end single-use solution – from upstream to final fill – and promotes itself as a partner that can accelerate drug development by providing all necessary disposables with shorter lead times. LePure’s rapid growth and quality focus have attracted global capital; it recently closed a major financing round co-led by Novo Holdings and General Atlantic, underscoring international confidence in China’s SUS capabilities.

Another prominent player, Zhejiang JYSS Bio-Engineering, established in 2014, was the first in China to commercialize a single-use bioreactor developed domestically. JYSS offers several SUB designs: the TOR series (traditional stirred tank), VOR series (bottom stirred SUB), and the innovative CUR Torrent bioreactor with its bubble-free oxygenation system. The CUR SUB’s patented mechanism provides high oxygen transfer rates without sparged bubbles, thereby protecting shear-sensitive cell cultures – a novel approach globally. JYSS also produces single-use mixers (ITD magnetic mixers and LMS levitating mixers) for volumes up to 1,000 L, as well as essential accessories like tube welders and sealers for sterile connection. Moreover, JYSS developed its own bioprocess film (EB1596) and disposable bioculture bags for media, buffer, and cell culture use. By 2021, JYSS had expanded with a large new manufacturing site (including automated assembly lines and cleanrooms) to meet growing demand. The company has attracted significant investment and won industry awards, reflecting its status as a leading innovator in China’s SUS scene. Notably, Chinese biopharma firms have started using JYSS’s SUBs in commercial manufacturing, a strong validation of local technology.

Tofflon and AUSTAR, discussed earlier for integrated solutions, also contribute to China’s SUS rise. Tofflon has leveraged its established relationships with Chinese biopharma companies to introduce single-use products (bioreactors, mixing bags, etc.) alongside its traditional equipment. AUSTAR, with its China-wide presence, has been an important distributor/partner for Western single-use products historically (for instance, it had a joint venture with ATMI LifeSciences years ago to produce packaging in Asia). Now, AUSTAR manufactures customised single-use assemblies and even hybrid systems within China, enhancing domestic supply.

Duoning Biotechnology, founded in 2005 in Shanghai, represents the new generation of one-stop bioprocess solution companies. Duoning produces a comprehensive range of single-use consumables: 2D/3D bags, bioprocess containers, filter capsules, connectors (“mouseholes” for tubing pass-through, etc.), and even single-use bioprocess instruments. A notable example is Duoning’s single-use automated filling system (DuoFill), which allows aseptic filling of bulk product into bags or bottles in a closed manner. This kind of innovation addresses the final leg of the manufacturing process, ensuring sterility up to the final container. Duoning has also made strategic acquisitions to bolster its offerings – in 2023 it acquired PreFluid, a Chinese maker of precision peristaltic pumps, to integrate into its single-use systems for better control of fluid handling. Duoning’s CEO highlighted that combining PreFluid’s pump expertise with Duoning’s disposables creates a complete “germ-free fluid delivery chain”, underscoring their goal to be a one-stop shop for bioprocess needs. Indeed, Duoning advertises itself as a leading integrated bioprocess solutions provider from development through commercial manufacturing. This mirrors the full-spectrum approach of Western giants, but with local manufacturing that can be more responsive to Chinese customers.

Collectively, these Chinese companies are not just copycats; they are innovating and driving competition in the SUS market. They often offer more cost-effective products and shorter delivery times, which has compelled global suppliers to improve their supply chains and pricing for the region. Additionally, Chinese SUS firms are beginning to expand internationally – for example, LePure and Duoning have started marketing their products in other Asian countries and even in Europe via distributors. The rise of China’s domestic SUS industry also boosts global supply resilience, by providing alternate sources for critical consumables (films, connectors, filters) that were once concentrated among a few Western suppliers.

From a regional strength perspective, China’s advantage lies in scale and speed. The domestic market’s sheer size allows companies to ramp up manufacturing volume quickly (driving down unit costs), and the entrepreneurial environment means new designs can be developed and iterated rapidly. Government support for biopharma innovation has also facilitated funding and infrastructure for SUS development (for instance, several SUS firms have benefitted from local subsidies and inclusion in national strategic industry lists). There is also a feedback loop where the presence of local SUS suppliers encourages more Chinese biotechs to build manufacturing in-country, which in turn generates more demand for SUS – a virtuous cycle fueling growth.

In summary, China’s emergence in single-use bioprocessing is a significant global development. It ensures that the SUS landscape is no longer an oligopoly; instead, a diverse set of suppliers across different continents can collectively drive innovation, stabilize supply, and perhaps even collaborate on setting international standards for quality and sustainability of single-use tech.

Regulatory and GMP Considerations for Single-Use Systems

The shift to single-use technology has brought new regulatory and GMP considerations that both suppliers and end-users must carefully manage. Unlike fixed stainless equipment, SUS are delivered pre-sterilized and pre-assembled, so manufacturers rely heavily on vendor qualification and incoming quality control rather than in-house sterilization and cleaning validation. Regulatory agencies (FDA, EMA, etc.) have generally embraced single-use tech, but with emphasis on material compatibility, leachables/extractables, and robust QA of the disposable components.

Material testing and compliance: All major SUS components are made from polymers and elastomers that must be biocompatible. Suppliers therefore conduct extensive testing on films, tubing, and connectors to meet standards like USP <88> Class VI (for biocompatibility) and to ensure no interference with the product. For example, Cytiva’s Fortem™ film underwent rigorous analyses for flex durability, weldability, and low extractables, and is engineered to maintain pH stability during long-term liquid storage. The film creates a protective environment suitable for cell culture and is tested under various stress conditions to manage any degradants. This level of testing is necessary to satisfy regulatory expectations that contact materials will not adversely impact product safety or efficacy. Companies often follow industry guidelines (e.g. BioPhorum Operations Group’s recommended extractables testing protocols) and provide extractables/leachables data packages to end-users for inclusion in filings. Merck, Sartorius, and others have sizable databases of extractables for their SUS products, and they continuously improve films (for instance, newer polyethylene-based films have reduced additive content to lower potential leachables).

Sterility assurance: Single-use assemblies are typically sterilized by gamma irradiation at the factory. GMP requires that this sterilization be validated. Vendors must adhere to ISO standards for radiation sterilization and provide certificates of sterility for each lot. The end-user, in turn, must ensure that the packaging of the SUS maintains sterility until use (meaning careful inspection for any shipping damage, and controlling the storage environment). Some regulatory guidance (e.g. EU Annex 1 for sterile manufacturing) has clauses applicable to single-use – for instance, the need to integrity-test single-use sterile filters prior to use (hence the PUPSIT requirement, which SUS vendors like Duoning now accommodate with specialized assemblies).

Change control and supply chain: A significant regulatory concern is change management for SUS components. Biopharma processes may be licensed to use specific bags, filters, etc., so if a supplier changes the film formulation or discontinues a connector, it could necessitate comparability studies. Therefore, strong partnerships between SUS suppliers and biomanufacturers are needed, with notifications of changes well in advance. Many suppliers have instituted rigorous change control procedures and even multi-sourcing of raw materials to ensure continuity. The pandemic highlighted the importance of diversified supply – as noted, reliance on a single source can be a vulnerability. Regulators are aware of this and have sometimes urged companies to qualify secondary suppliers for key single-use components.

GMP documentation and validation: Implementing single-use systems still requires validation, but the focus shifts. Instead of cleaning validation, companies perform leachables studies (usually worst-case extraction under process conditions, and toxicological evaluation of any compounds found). Integrity testing of SUS assemblies (especially critical ones like bioreactor bags) may be done via pressure decay tests or imaging methods to ensure no pinhole leaks. Suppliers assist by developing validation guides and even doing some tests at their end. For instance, AUSTAR offers services from system risk assessment to compatibility testing to help clients validate that a given single-use system is fit for their purpose. During facility inspections, regulators expect to see that single-use systems are incorporated into the site’s quality system – including incoming inspection, lot traceability, and operator training on proper handling (since improper installation of a bag, for example, could cause failure).

Notably, extractables and leachables (E&L) have been a key focus area. The industry through BPOG published standardized extractables test protocols, and pharmacopeias (USP, Ph. Eur.) have been updating chapters to address plastic components in manufacturing. Many new therapeutics (like cell and gene therapies) are produced in entirely single-use workflows, and regulatory submissions include detailed sections on the SUS, with data on E&L and justification of their use. So far, there have been no reports of patient safety issues directly linked to SUS leachates, a testament to the diligent work in qualifying materials. However, vigilance remains important, especially as SUS are applied to new processes (e.g. organic solvents in some steps could interact with certain plastics differently than aqueous buffers do).

Training and human factors: GMP compliance also extends to ensuring that operators use the single-use systems correctly. This means new SOPs – for example, how to unpack and install a sterile bag without compromising it, how to make aseptic connections using tube welders or connectors, etc. Many companies have had to build these competencies, sometimes with vendor support. The upside is that once implemented, SUS can simplify operations (pre-sterilized kits reduce on-site cleaning verification, etc.), but they introduce different failure modes (like a dropped bag or an incorrectly closed clamp can cause a loss of sterility or spillage).

In summary, regulatory agencies accept single-use technology as part of modern GMP manufacturing, but both suppliers and users must maintain high standards of quality assurance. The key GMP impacts include rigorous material qualification, ensuring sterility of disposable units, robust change control, and appropriate validation of each single-use component’s function. As single-use adoption matures, these practices are becoming standardised. In fact, regulators now sometimes view single-use as reducing certain risks (like cross-contamination) – a well-known benefit is that SUS “eliminate the risk of product cross-contamination between batches” by design. The industry’s collective experience and data over the past decade have provided confidence that, with proper controls, single-use systems can be as GMP-compliant and reliable as traditional equipment.

Sustainability Initiatives for Single-Use Systems

One of the most significant criticisms of single-use bioprocessing is its environmental impact, specifically the plastic waste generation. A typical 2,000 L SUB run might produce tens of kilograms of plastic waste (from the reactor bag, filters, tubing, etc.), which is usually treated as biohazardous and incinerated. While SUS reduce water and chemical usage (no cleaning needed) and thus lower the environmental footprint in those areas, the long-term sustainability of disposing large amounts of polymer waste has been under scrutiny.

The industry, to its credit, has acknowledged this “elephant in the room” and is taking steps toward greener practices. A multi-company collaboration exemplifies this: in 2022–2023, Sanofi (a major SUS end-user), Sartorius (a SUS supplier), and Veolia (a waste management firm) conducted a landmark study on recycling single-use technology. This tripartite project, published in La Vague journal, examined the technical challenges and potential solutions for recycling used bioprocess plastics. Some findings included the need for better segregation of waste (since not all single-use waste is biohazardous – WHO estimates ~85% of healthcare plastic waste is non-hazardous if properly sorted). If single-use waste can be decontaminated and sorted, a significant portion might be amenable to material recycling or energy recovery. However, the mix of polymers (polyethylene, EVA, polycarbonate, etc.) in SUS and the presence of multilayer films complicate conventional recycling streams. The consortium has been exploring advanced recycling (like pyrolysis to break plastics into fuel) and designing new single-use products with recyclability in mind.

Several suppliers have introduced “sustainable” single-use product lines. As mentioned, Thermo Fisher’s Aegis 5-14 film is partly bio-based and yields a net negative carbon footprint in its production. Using bio-derived polyethylene (from plant sources) reduces reliance on fossil fuels for resin. Thermo also reported reducing packaging waste through design changes (the BioTitan retainers cut down on extra protective packaging by acting as integrated bag supports). Sartorius has been working on high-density packaging to ship more bags per box, and has investigated the use of recycled materials in non-product-contact parts of their assemblies. Merck’s “BioContinuum™ Platform” includes a Buffer Delivery System that significantly cuts down the number of single-use buffer containers needed through on-demand buffer concentrates, indirectly reducing waste.

Another approach is reuse in non-GMP contexts: some groups have repurposed used single-use plastic (after proper cleaning) for uses like bench training units or lower-grade applications, to squeeze additional life out of the materials. While the disposables are not intended for multiple bioprocess runs, creative secondary uses can mitigate waste.

Recycling programs are slowly emerging. A few suppliers have pilot programs where they collect used disposable materials from clients to send to specialised recycling partners. For example, there are instances of single-use bioreactor bags being converted into plastic lumber for park benches. These are small-scale now, but as volume grows, economies of scale might make such programs more viable. Regulatory classification of the waste is an issue – if it’s considered biohazardous, most jurisdictions require incineration. But if biopharma companies can demonstrate effective decontamination (e.g. using enzymatic treatments or irradiation post-use), then large portions of the plastic waste could be treated as regular recyclable waste. That is a regulatory frontier yet to be fully resolved.

One promising development is designing for circularity. Suppliers are exploring making single-use assemblies from more uniform materials so that recycling is easier. For instance, using all-polyethylene constructions (no mixed polymer layers) could allow simple melting and remoulding. There’s also interest in biodegradable plastics for certain single-use items, though for critical process contact, biodegradables may not yet offer the required robustness and purity.

It’s worth noting that even when single-use plastics are incinerated, modern waste-to-energy incinerators can capture energy and have scrubbers to limit emissions, so the impact is mitigated versus uncontrolled burning or landfilling. Still, the optics and corporate sustainability goals push companies to do better than incineration. Many big pharma companies using SUS have sustainability targets that include increasing the percentage of bioprocess plastics that get recycled or recovered.

In summary, the industry recognises that for single-use technology to be truly sustainable long-term, innovations in recycling and materials are needed. Early collaborations (Sanofi–Sartorius–Veolia etc.) are laying the groundwork by highlighting technical and regulatory hurdles and potential solutions. In parallel, incremental improvements by suppliers (bio-based films, reduced packaging, concentrate formats) are already reducing the carbon and waste footprint of SUS. As these efforts mature, we can expect the next generation of single-use systems to not only deliver on performance but also on environmental responsibility, aligning with the biopharma sector’s broader push toward greener manufacturing.

Accelerating Drug Development and Production

Ultimately, the innovations in single-use systems are not just engineering feats; they are enabling faster and more flexible drug development and manufacturing. SUS technology has significantly shortened the time-to-clinic and time-to-market for biopharmaceutical products in several ways:

• Rapid facility deployment and tech transfer: Building a stainless steel facility can take 3–5 years; in contrast, a single-use modular facility can be up and running in 1–2 years or even less, as seen with Cytiva’s FlexFactory installations. This speed was crucial during the COVID-19 pandemic, where vaccine manufacturing sites were established in record time, often leveraging single-use equipment that could be delivered and qualified swiftly. Fast deployment means new therapeutics (including pandemic vaccines or novel cell therapies) can be manufactured at scale much sooner, potentially saving lives. Moreover, tech transfer of a process to multiple sites is eased by single-use – a company can replicate an identical suite of SUS-based equipment in different locations, ensuring consistent process performance without the minor variability that different fixed systems might introduce.
• Flexible scale-up/scale-down: In early development, having the ability to run many small-scale parallel experiments (using disposable minibioreactors like Sartorius Ambr® or shake flasks with single-use liners) speeds process optimisation. Later, as demand forecasts change, single-use facilities can scale-out production by running multiple 2,000 L SUBs in parallel or scale-up if a larger SUB (like 5,000 L) is available – offering flexibility that fixed assets lack. Companies can respond to market changes (e.g. needing more vaccine doses) by quickly adding more single-use units. As an example of throughput gains, Thermo’s data showed that switching from glass bioreactors to disposable ones allowed ~27% more experiments annually in a process development lab, accelerating the iteration cycle for process design.
• Reduced turnaround and higher productivity: Single-use eliminates cleaning downtime. Turnaround between batches is basically the time to remove the used assembly and install a new one, which can be mere hours instead of days. This raises the number of batches that can be produced in a given timeframe. Particularly for multi-product or multi-stage facilities, the schedule compression is dramatic. One can manufacture a product, then swiftly reconfigure (by swapping single-use flowpaths) to manufacture another product, with minimal risk of cross-contamination. This agility is crucial for contract manufacturers and for companies with diverse pipelines.
• Process intensification: Innovations like integrated perfusion in SUBs (Sartorius with XCell ATF) and continuous processing platforms (Merck’s BioContinuum, etc.) mean higher volumetric productivity. If a single 2,000 L SUB can produce what used to require a 10,000 L stainless tank (through cell density or continuous operation), development and production can be done in smaller facilities, faster and with less upfront investment. This lowers the barrier to entry for producing new therapies, encouraging more innovation in biotech (e.g. niche diseases can be pursued because manufacturing is more attainable at smaller scale).
• Enabling new modalities: Single-use systems have been a key enabler for emerging therapeutic modalities such as gene therapies, cell therapies, and mRNA vaccines. These often require specialized, flexible manufacturing setups and are produced in relatively small volumes but with stringent aseptic conditions. Traditional stainless facilities are ill-suited for such applications due to their scale and changeover limitations. Single-use, by contrast, allows bespoke configuration (e.g. a closed gamma-irradiated kit for a cell therapy process) that can be set up in an isolator or cleanroom quickly. For instance, CAR-T cell manufacturing for personalised therapies uses many single-use components (bioreactors, cell separation cartridges, tubing sets), which make it feasible to run multiple patient batches in parallel without risk of mix-up. Cytiva’s initiative to “democratize” mRNA manufacturing – providing scalable single-use lipid nanoparticle formulation systems – is another example of SUS accelerating a cutting-edge field. By lowering the technical barriers to manufacturing, single-use tech allows researchers and smaller companies to translate lab discoveries into clinical products faster than before.
• Improved reliability and fewer process failures: Interestingly, the latest single-use designs have also improved operational reliability. Features like Cytiva’s leak-resistant bag design for its new mixers mean fewer batch failures due to equipment issues (e.g. a lost batch from a mixing bag leak is extremely costly). As these systems incorporate smarter design and better sensors (single-use disposable pH, DO, pressure sensors are now common), operators have better control and insight, reducing the risk of deviations. In turn, this leads to more efficient manufacturing campaigns and less downtime investigating issues.

All these factors combine to speed up the pipeline from development to commercial supply. New vaccines, biologics, and even advanced therapies can reach patients faster thanks to the agility conferred by SUS. The time savings are seen in development (quick experiments, easy scale-up), facility readiness (modular, pre-validated units), and production cycle times (fast changeovers, fewer cleaning/validation holds). For patients waiting on life-saving treatments, these efficiency gains can make a meaningful difference.

From a strategic perspective, the widespread adoption of single-use systems also changes how companies plan their manufacturing network. Instead of building one large fixed factory for a blockbuster (which might become underutilized if demand falls), firms are opting for smaller, single-use based plants that can be replicated or relocated as needed. This de-risks investments and encourages a more distributed manufacturing model – which we saw play out during COVID-19, when vaccine production was set up in multiple countries using similar single-use platforms to ensure global supply coverage.

Single-use systems have matured from a novel idea to the driving engine of modern biopharma manufacturing. The innovations by the likes of Cytiva, Thermo, Sartorius, Merck, ABEC, and the new wave of Chinese companies are continuously expanding what’s possible with SUS – from bigger scales and continuous processing to smarter, greener designs. These advancements, in turn, accelerate the pace at which new therapies are developed, tested, and delivered to patients. As the industry moves forward, we can expect single-use technologies to become even more integrated with digital systems (for monitoring and automation) and to play a central role in future facility concepts (such as fully flexible “Biotech on Demand” plants). For biopharma professionals and strategists, staying abreast of SUS innovations is crucial, as these systems are reshaping both the technical and business landscape of drug production. The ongoing convergence of global expertise – Western pioneers and Eastern new entrants – promises a vibrant, competitive field that will continue to push single-use bioprocessing to new heights in the years ahead.