What is an mRNA vaccine and how does it work?

mRNA Vaccines: Key questions and answers

In recent years, messenger RNA (mRNA) vaccines have become a central topic in biotechnology and public health. This type of vaccine, brought into the spotlight by its role in the COVID-19 pandemic, represents an innovative approach to disease prevention and treatment. Below, we present an article structured around frequently asked questions about mRNA vaccines, with answers based on up-to-date scientific information. Each section addresses a common concern, from how they work to their safety, and explores the future of this technology. 

What vaccines use mRNA?

Currently, the only mRNA vaccines approved for human use are those developed against COVID-19. Specifically, the Comirnaty vaccine by Pfizer-BioNTech and Spikevax by Moderna use mRNA technology to induce immunity against SARS-CoV-2. These vaccines have been administered to hundreds of millions of people worldwide with high effectiveness in preventing severe COVID-19.

Other companies have also worked on mRNA vaccines. For example, the German company CureVac was a pioneer in researching mRNA vaccines for rabies, influenza, and other diseases, although its first COVID-19 candidate did not reach the desired efficacy. In China, companies like Walvax have developed mRNA vaccine candidates against COVID-19, and global pharmaceutical companies (such as Sanofi or GSK) have invested in this technological platform. This reflects a broad global interest in mRNA vaccines as a new tool to fight infectious diseases.

What does mRNA do in the body?

mRNA vaccines work differently from traditional vaccines. Instead of introducing a weakened or inactivated virus, or a viral protein, these vaccines deliver a synthetic messenger RNA fragment that contains the instructions to produce a specific protein from the pathogen. Once the mRNA enters our cells (especially muscle cells near the injection site), it acts as a template for the cell to produce the target viral protein, for example the spike protein of the coronavirus.

By producing this foreign protein, the immune system recognizes it as a threat and mounts a defensive response: it generates specific antibodies and immune cells trained to attack the real pathogen. It's important to emphasize that the vaccine mRNA does not enter the cell nucleus or alter human DNA. Furthermore, after fulfilling its role, the mRNA is quickly broken down by the cell and eliminated from the body. Thus, the vaccine enables our body to practice and prepare its defenses without exposing us to the whole virus or causing disease. In essence, the mRNA in the body acts as a temporary messenger that teaches our immune system how to protect itself, and then disappears.

Infographic showing the 5-step process of how mRNA vaccines work: injection, cell entry, protein production, immune activation, and protection.

Is the mRNA vaccine safe?

Yes. mRNA vaccines have shown a very favorable safety profile. Like other vaccines, they underwent rigorous clinical trials and received approval from regulatory agencies such as the FDA (in the U.S.) and EMA (in Europe) after confirming their safety and efficacy. Millions of people have been vaccinated with mRNA formulas in recent years, and ongoing monitoring has found no widespread or long-term adverse effects linked to these vaccines. In fact, experts state it is far more likely to suffer serious consequences from contracting a preventable disease than from vaccination itself.

There are clear biological reasons for their safety. First, mRNA vaccines do not contain live virus, so they cannot cause the disease they are meant to prevent. Additionally, the mRNA does not interfere with our genome: it does not enter the cell nucleus or modify DNA, and it remains in the body only long enough to generate immunity. The most common side effects are similar to those of other vaccines (see the side effects section) and tend to be mild and short-lived. Severe adverse effects, such as strong allergic reactions or heart inflammation, are extremely rare and have occurred mainly in specific populations, typically with a benign clinical course. In short, based on the available evidence, mRNA vaccines are considered safe and a crucial tool for public health.

How long does it stay in the body?

A common concern is how long the vaccine’s mRNA molecule remains in the body. The answer is very little time. mRNA is, by nature, an unstable and short-lived molecule; outside cells, it quickly degrades. After vaccination, the mRNA stays in the body only long enough for cells to produce the target protein and activate the immune system, a process that takes a few days at most.

Our bodies have enzymes and mechanisms designed to break down messenger RNA once it has been used. In fact, inside cells, mRNA is constantly recycled: after producing the instructed proteins, it is destroyed and eliminated. Studies and follow-up data have confirmed that vaccine mRNA does not persist long-term in any tissue. What it leaves behind is the trained immune response (antibodies and memory cells), which can last for months or years, protecting us from illness. Therefore, the mRNA molecule fulfills its mission and then quickly disappears, leaving no trace in the body.

What diseases can mRNA treat?

The mRNA vaccine platform opens the door to addressing multiple diseases, both infectious and non-infectious. In the realm of infectious diseases, mRNA can be adapted to encode proteins from various viruses and pathogens, theoretically allowing vaccines for many illnesses. It has already proven effective against COVID-19, and experimental mRNA vaccines have been studied for influenza, rabies, Zika virus, respiratory syncytial virus (RSV), among others. While many of these vaccines are still in the research phase, early results suggest that mRNA is a versatile platform for preventing diseases caused by very different viruses.

Beyond infections, mRNA vaccines can also be used in therapeutic applications. A prominent example is their potential in cancer treatment. For years, scientists have explored personalized mRNA vaccines that help the immune system recognize and attack specific tumors. Clinical trials are underway for mRNA vaccines targeting various cancers (like melanoma, pancreatic cancer, or colorectal cancer), sometimes in combination with immunotherapies to enhance the body’s response. Although no mRNA cancer vaccines have been approved yet, early results are promising and suggest this technique could lead to new types of therapeutic vaccines in the future.

In short, mRNA has the potential to tackle a wide range of diseases. Any condition where a key protein target can be identified (whether viral, bacterial, or an abnormal protein in cancer cells) can potentially be addressed with an mRNA vaccine that instructs the body to fight it. This includes emerging infections as well as complex conditions like cancer, marking an exciting frontier in preventive and personalized medicine.

What was the first mRNA vaccine?

Although mRNA vaccine research has been ongoing for decades, the first mRNA vaccine approved for general population use was the COVID-19 vaccine developed in 2020. Specifically, the Pfizer-BioNTech vaccine (Comirnaty) received emergency use authorizations in late 2020 in several countries (such as the United Kingdom and the United States), becoming the first mRNA vaccine used on a large scale in humans. It was closely followed by Moderna’s vaccine (Spikevax), approved in early 2021. Both drugs marked a historic milestone, as they were the first real-world proof of this technology’s effectiveness in disease prevention.

Interestingly, before the COVID-19 pandemic, clinical trials for mRNA vaccines had already been conducted, though none resulted in licensed vaccines. For instance, between 2013 and 2017, experimental mRNA vaccines for rabies were tested in humans, and animal trials were conducted for diseases like Ebola. However, the global health emergency in 2020 dramatically accelerated the development and approval of an mRNA vaccine. As the European Medicines Agency stated, “the first mRNA vaccine approved in Europe was in 2020 against COVID-19.” This event marked the beginning of a new era in vaccinology.

What are the side effects?

Like any vaccine or medication, mRNA vaccines can cause side effects, though in the vast majority of cases, they are mild and short-lived. The most common adverse effects linked to mRNA vaccines (mainly identified with the COVID-19 vaccines from Pfizer-BioNTech and Moderna) include: pain or tenderness at the injection site, redness or swelling in the arm, fatigue, headache, low-grade fever, chills, and muscle or joint pain. These symptoms are usually signs of the immune system being activated and typically resolve on their own in a day or two. Many people experience only mild local discomfort.

Serious side effects are rare. Severe allergic reactions (anaphylaxis) are possible but extremely rare, which is why a 15–30-minute observation period after the shot is recommended as a precaution. Another rare effect associated with mRNA COVID-19 vaccines is myocarditis or pericarditis, which is inflammation of the heart or surrounding tissue. This effect has been observed mainly in young males after the second dose and occurs at a very low frequency (around a few dozen cases per million vaccinated). Moreover, reported cases have typically been mild, responded well to treatment, and resulted in full recovery for most patients. Regulatory bodies such as the Spanish Agency for Medicines and Health Products (AEMPS) have concluded that myocarditis related to the vaccine is very rare, and that the benefits of vaccination far outweigh this infrequent risk.

In summary, the side effects of mRNA vaccines are similar to those of other modern vaccines. Most people will experience mild, temporary symptoms or none at all, and only a very small proportion will experience serious effects. Global monitoring over the past years strongly supports the safety of these vaccines, and any rare risks are carefully tracked by health authorities.

What brands manufacture mRNA vaccines?

Several leading biotechnology and pharmaceutical companies are behind the development and manufacturing of mRNA vaccines. The most well-known brands are, without a doubt, Pfizer-BioNTech and Moderna. Pfizer (a U.S.-based multinational) partnered with the German biopharma company BioNTech to create the Comirnaty vaccine against COVID-19, while Moderna (a U.S. company) developed the Spikevax vaccine independently. Both organizations leveraged years of prior mRNA research and, in record time, produced the first mRNA vaccines approved during the pandemic.

Another pioneering company is CureVac, a German start-up that has focused on mRNA technology for over 20 years. CureVac conducted early clinical trials for mRNA vaccines against rabies and other viruses before 2020. Although its first COVID-19 vaccine did not achieve optimal efficacy results, it continues developing a second-generation mRNA vaccine in partnership with other firms.

In addition to these, pharmaceutical giants such as Sanofi (in alliance with Translate Bio) and GlaxoSmithKline (GSK) have invested in mRNA vaccine projects for influenza and other diseases. In Asia, companies like Walvax and Abogen in China have developed their own mRNA vaccines against the coronavirus. Governments and international coalitions, supported by the WHO, are also promoting technology transfer centers so that more countries can produce mRNA vaccines.

In short, while Pfizer-BioNTech and Moderna are the flagship brands associated with mRNA vaccines, there is an entire ecosystem of innovative companies (CureVac, BioNTech, Moderna, among others) and traditional pharmaceutical giants entering this space. This global collaboration is expanding the production capacity and reach of mRNA vaccines worldwide.

How were these vaccines developed?

mRNA vaccines may seem like a sudden breakthrough, but they are actually the result of decades of scientific research. Messenger RNA was discovered in 1961, laying the theoretical foundations for its use. However, for a long time, it was considered too unstable for medical applications: it's a single-stranded molecule that degrades quickly outside controlled environments. To use mRNA as a vaccine, scientists had to overcome several challenges:

  • Stability of mRNA: In the 1970s, a key breakthrough was made by encapsulating mRNA in a lipid layer, which protects it from degradation. This fatty coating forms a nanoparticle that allows mRNA to reach the inside of cells intact.

These lipid nanoparticles protect the mRNA and facilitate its delivery into cells. This innovation was essential to overcome the natural fragility of mRNA, since without protection, the body would destroy it before it could function. Encapsulating it in lipid nanoparticles enables mRNA to enter cells and direct protein production before degrading.

  • Synthetic mRNA production: In the 1980s and 1990s, significant advances were made. Scientists learned to produce mRNA molecules in the lab and modify them slightly to improve performance. In 2005, researchers like Katalin Karikó introduced chemical modifications (such as pseudouridine) to synthetic mRNA to make it less visible to the innate immune system, avoiding adverse reactions and boosting protein expression. This solidified the viability of modern mRNA vaccines.

  • Pre-pandemic trials: Between 2009 and 2019, early-stage clinical trials were conducted for mRNA vaccines against diseases like rabies, HIV, influenza, and various cancers. These small-scale studies showed that mRNA vaccines could elicit immune responses in humans. Small biotech firms like BioNTech and CureVac were already testing mRNA cancer vaccines before 2020, building knowledge on formulation and dosing.

  • Pandemic as a catalyst: The arrival of the COVID-19 pandemic in late 2019 and early 2020 was the major catalyst. The scientific community, which had been fine-tuning mRNA technology for years, could rapidly design vaccines against the new coronavirus. Within days of obtaining the SARS-CoV-2 genetic sequence, researchers created vaccine candidates almost immediately. No vaccine had ever been developed this quickly: the design, production, and early safety/efficacy testing was completed in under a year—when it normally takes a decade or more. This was possible due to previous research and unprecedented collaboration between research centers, companies, and health authorities.

Thus, mRNA vaccines were developed by combining scientific persistence and technological innovation over more than 30 years. Far from being a rushed invention, they are the result of many iterations and learnings: from how to protect the molecule, to how to manufacture it at scale. The pandemic simply offered the opportunity to prove their potential on a global stage, validating decades of effort in labs around the world.

What diseases are being studied for mRNA vaccine use?

Following the success against COVID-19, attention has turned to harnessing mRNA technology for other diseases. Currently, mRNA vaccines are being researched for several high-impact infectious diseases as well as complex health problems. The conditions under investigation include:

  • Emerging infectious diseases: Clinical trials are underway for mRNA vaccines targeting viruses such as seasonal influenza, respiratory syncytial virus (RSV), and Zika virus, among others. These pathogens represent persistent or re-emerging threats, and mRNA vaccines could provide faster responses to mutations or new outbreaks.

  • HIV/AIDS: The human immunodeficiency virus has eluded an effective vaccine for decades. mRNA’s flexibility offers a new path to attempt vaccines against HIV by designing sequences that train the immune system to neutralize this highly variable virus. Several institutions, including the HIV Vaccine Initiative, are working on mRNA-based HIV vaccine prototypes.

  • Malaria and Tuberculosis: These are two of the deadliest infectious diseases globally. Projects are already underway to develop mRNA vaccines against malaria and tuberculosis, aiming to improve or complement existing traditional vaccines. For instance, BioNTech launched a phase I trial for a malaria mRNA vaccine in 2022, and a TB mRNA vaccine is being explored focusing on key proteins from Mycobacterium tuberculosis.

  • Cancer: Beyond the therapeutic vaccines already mentioned, researchers are exploring mRNA use to prevent cancers caused by viruses (such as a potential vaccine to prevent cancers linked to the Epstein-Barr virus, or enhancements to the HPV vaccine). Likewise, personalized mRNA cancer vaccines are being tested to teach cancer patients’ immune systems to attack specific tumor mutations.

  • Other applications: Scientists are exploring whether mRNA techniques could be used to induce tolerance in autoimmune diseases or regenerate tissues via growth factors. There is also interest in non-vaccine mRNA therapies, such as treating genetic diseases by supplying mRNA for a functional protein the patient cannot produce. These uses are still in early stages but reflect the wide range of possibilities.

In conclusion, mRNA vaccine research spans from classic infectious diseases (flu, HIV, malaria, etc.) to frontiers like cancer and rare diseases. The speed at which an mRNA can be designed for a new target has the scientific community optimistic about its potential for future vaccines. Many trials are underway worldwide, and it is likely that in the coming years we will see the first non-COVID-19 mRNA vaccines become a reality.

How does it differ from other vaccines?

mRNA vaccines differ fundamentally from other traditional vaccine types (such as inactivated viruses, attenuated viruses, or protein subunit vaccines):

  • Mechanism of action: The key difference is what is introduced into the body. Classical vaccines often deliver the antigen directly (for example, a viral protein) or even the whole weakened/inactivated pathogen. In contrast, mRNA vaccines deliver only the genetic blueprint (mRNA) so our own cells can produce the harmless antigen. That is, they turn the body into the "factory" for the immunogenic protein. This eliminates any risk of infection from the vaccine, as no live virus is injected.

  • Speed and adaptability: mRNA vaccines are quick to design and manufacture compared to others. Once the genetic sequence of a pathogen is known, the corresponding mRNA can be synthesized in weeks. There’s no need to grow viruses in eggs or cells for months, as with some traditional vaccines. This "genetic code" platform enabled vaccine development at record speed during the pandemic (under a year, when >5–10 years is typical). Additionally, if a virus mutates, updating an mRNA vaccine is as simple as modifying the mRNA sequence—a much faster process than reformulating conventional vaccines.

  • Composition and manufacturing: Other vaccines often contain chemical adjuvants to boost the immune response; mRNA vaccines typically do not need them, as the delivery of mRNA (and the resulting protein) naturally stimulates the immune system. mRNA vaccines are formulated with lipid nanoparticles (microscopic fat droplets) that protect the mRNA and help it enter cells—something we don’t see in traditional vaccines. From a manufacturing perspective, producing mRNA is a synthetic biotech process (in vitro transcription), different from virus culture or protein purification, and can be rapidly scaled once optimized.

  • Storage: A practical difference is that early mRNA vaccines required ultra-cold storage (e.g., -70°C for Pfizer-BioNTech) due to mRNA fragility. In contrast, many conventional vaccines are kept refrigerated (2–8°C). However, new formulations are being developed to improve mRNA vaccine stability. mRNA vaccines also typically come in frozen multi-dose vials, whereas others may be single-dose and ready to use.

In summary, mRNA vaccines differ through their genetic-based approach: instead of supplying the antigen or the germ, they deliver the instructions to make it. This provides advantages in development speed and strong immune response but also challenges such as initial cold-chain requirements. Despite the differences, the ultimate goal remains the same as with any vaccine: to safely and effectively prepare the immune system to defend against a pathogen.

Comparison table showing the main differences between mRNA vaccines and traditional vaccines: mechanism, speed, formulation, cold storage, immunogenicity, and scalability.

Conclusion

mRNA vaccines have revolutionized immunology by demonstrating a new way to protect health. Their rapid development and adaptability make them a valuable tool against pandemics and other difficult diseases. Although challenges remain (like improving their stability and expanding their use to more conditions), success against COVID-19 has validated decades of research and opened a promising path for future vaccines and genetic therapies.

In this progress, the role of the biotech industry and its technology providers is essential. Companies like TECNIC have driven biotechnology forward by providing essential tools and equipment to bring these vaccines from the lab to large-scale production. For example, TECNIC’s bioreactors and tangential flow filtration (TFF) systems enable optimal cell culture and efficient mRNA production, ensuring a smooth transition from research to industrial-scale manufacturing. These technological innovations ensure that mRNA vaccines can be manufactured safely, quickly, and in sufficient quantities to meet global needs. As TECNIC highlights, its bioreactors can be tailored to the specific demands of mRNA vaccines, reflecting a commitment to excellence and innovation in public health.

In short, the convergence of scientific breakthroughs and support from specialized companies has made mRNA vaccines a reality today. As we continue exploring new applications (from cancer to malaria) and improving these vaccines, collaboration between science and industry will be key. Thanks to this synergy, we are moving toward a future where disease prevention and treatment will be more agile, accessible, and effective than ever before.

mRNA Vaccine FAQs

Frequently Asked Questions about mRNA Vaccines

1. What is an mRNA vaccine?

It is a vaccine that uses messenger RNA instructions to help your cells produce a viral protein and trigger an immune response against it.

2. Are mRNA vaccines safe?

Yes. They have been widely studied and administered to millions of people, showing a strong safety profile and mostly mild, short-term side effects.

3. What diseases can mRNA vaccines prevent?

Currently they prevent COVID-19, but vaccines are being developed for flu, rabies, HIV, RSV, malaria, tuberculosis, and even certain types of cancer.

4. Does mRNA affect your DNA?

No. mRNA does not enter the cell’s nucleus and does not interact with your DNA. It is broken down naturally by the body shortly after doing its job.

5. How long does mRNA stay in the body?

Just a few days. Once the viral protein is produced, the body quickly degrades and eliminates the mRNA through natural processes.

References

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We understand the importance of flexibility and efficiency in laboratory processes. That's why our equipment is designed to be compatible with Cassette filters, an advanced solution for a variety of filtration applications. Although we do not manufacture the filters directly, our systems are optimized to take full advantage of the benefits that Cassette filters offer.

Cassette filters are known for their high filtration capacity and efficiency in separation, making them ideal for ultrafiltration, microfiltration, and nanofiltration applications. By integrating these filters into our equipment, we facilitate faster and more effective processes, ensuring high-quality results.

Our equipment, being compatible with Cassette filters, offers greater versatility and adaptability. This means you can choose the filter that best suits your specific needs, ensuring that each experiment or production process is carried out with maximum efficiency and precision.

Moreover, our equipment stands out for its 100% automation capabilities. Utilizing advanced proportional valves, we ensure precise control over differential pressure, transmembrane pressure, and flow rate. This automation not only enhances the efficiency and accuracy of the filtration process but also significantly reduces manual intervention, making our systems highly reliable and user-friendly.

Hollow Fiber

We recognize the crucial role of flexibility and efficiency in laboratory processes. That's why our equipment is meticulously designed to be compatible with Hollow Fiber filters, providing an advanced solution for a broad spectrum of filtration applications. While we don't directly manufacture these filters, our systems are finely tuned to harness the full potential of Hollow Fiber filters.

Hollow Fiber filters are renowned for their exceptional performance in terms of filtration efficiency and capacity. They are particularly effective for applications requiring gentle handling of samples, such as in cell culture and sensitive biomolecular processes. By integrating these filters with our equipment, we enable more efficient, faster, and higher-quality filtration processes.

What sets our equipment apart is its 100% automation capability. Through the use of sophisticated proportional valves, our systems achieve meticulous control over differential pressure, transmembrane pressure, and flow rate. This level of automation not only boosts the efficiency and precision of the filtration process but also significantly diminishes the need for manual oversight, rendering our systems exceptionally reliable and user-friendly.

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Cellular configuration

The cellular configuration of the eLab Advanced is equipped with a pitched-blade impeller designed to support efficient mixing for cell culture processes in both laboratory development and early scale-up. The blade geometry promotes mainly axial flow, helping to distribute gases, nutrients and pH control agents uniformly throughout the vessel while keeping shear stress at a moderate level. This makes it suitable for mammalian, insect and other shear-sensitive cell lines when operated with appropriate agitation and aeration settings. In combination with the vessel aspect ratio and baffle design, the pitched blade supports stable foaming behavior and reproducible oxygen transfer, which is essential when comparing batches or transferring processes between working volumes.

Operators can fine-tune agitation speed to balance oxygen demand and mixing time without excessively increasing mechanical stress on the culture. 

Cellular configuration

The cellular configuration of the eLab Advanced is equipped with a pitched-blade impeller designed to support efficient mixing for cell culture processes in both laboratory development and early scale-up. The blade geometry promotes mainly axial flow, helping to distribute gases, nutrients and pH control agents uniformly throughout the vessel while keeping shear stress at a moderate level. This makes it suitable for mammalian, insect and other shear-sensitive cell lines when operated with appropriate agitation and aeration settings. In combination with the vessel aspect ratio and baffle design, the pitched blade supports stable foaming behavior and reproducible oxygen transfer, which is essential when comparing batches or transferring processes between working volumes.

Operators can fine-tune agitation speed to balance oxygen demand and mixing time without excessively increasing mechanical stress on the culture. 

Cellular configuration

The cellular configuration of the eLab Advanced is equipped with a pitched-blade impeller designed to support efficient mixing for cell culture processes in both laboratory development and early scale-up. The blade geometry promotes mainly axial flow, helping to distribute gases, nutrients and pH control agents uniformly throughout the vessel while keeping shear stress at a moderate level. This makes it suitable for mammalian, insect and other shear-sensitive cell lines when operated with appropriate agitation and aeration settings. In combination with the vessel aspect ratio and baffle design, the pitched blade supports stable foaming behavior and reproducible oxygen transfer, which is essential when comparing batches or transferring processes between working volumes.

Operators can fine-tune agitation speed to balance oxygen demand and mixing time without excessively increasing mechanical stress on the culture. 

Microbial configuration

The microbial configuration of the eLab Advanced is equipped with a Rushton turbine specifically designed for high-oxygen-demand processes such as bacterial and yeast fermentations. The radial-flow impeller generates strong mixing and intense gas dispersion, promoting high oxygen transfer rates and fast homogenization of nutrients, antifoam and pH control agents throughout the vessel. This makes it particularly suitable for robust microbial strains operating at elevated agitation speeds and aeration rates.

Operators can adjust agitation and gas flow to reach the required kLa while maintaining consistent mixing times, even at high cell densities. This configuration is an excellent option for users who need a powerful, reliable platform to develop and optimize microbial processes before transferring them to pilot or production scales.

Technical specifications

Materials and finishes

Typical
  • Product-contact parts: AISI 316L (1.4404), typical Ra < 0.4 µm (16 µin)
  • Non-contact parts/skid: AISI 304/304L
  • Seals/elastomers: platinum-cured silicone, EPDM and/or PTFE (material set depends on selection)
  • Elastomers compliance (depending on selected materials): FDA 21 CFR 177.2600 and USP Class VI
  • Surface treatments: degreasing, pickling and passivation (ASTM A380 and ASTM A968)
  • Roughness control on product-contact surfaces

Design conditions

Pressure & temperature

Defined considering non-hazardous process fluids (PED group 2) and jacket steam/superheated water (PED group 5), depending on configuration and project scope.

Reference design envelope
Mode Element Working pressure (bar[g]) Working pressure (psi[g]) T max (°C / °F)
ProcessVessel0 / +2.50 / +36.3+90 / 194
ProcessJacket0 / +3.80 / +55.1+90 / 194
SterilisationVessel0 / +2.50 / +36.3+130 / 266
SterilisationJacket0 / +3.80 / +55.1+150 / 302
Jacket working pressure may also be specified as 0 / +4 bar(g) (0 / +58.0 psi[g]) depending on design selection; final values are confirmed per project.

Pressure control and safeguards

Typical
  • Designed to maintain a vessel pressure set-point typically in the range 0 to 2.5 bar(g)
  • Aseptic operation commonly around 0.2 to 0.5 bar(g) to keep the vessel slightly pressurised
  • Overpressure/underpressure safeguards included per configuration and regulations
  • Pressure safety device (e.g., rupture disc and/or safety valve) included according to configuration

Agitation

Reference ranges
Working volume MU (Cell culture), reference MB (Microbial), reference
10 L0 to 300 rpm0 to 1000 rpm
20 L0 to 250 rpm0 to 1000 rpm
30 L0 to 200 rpm0 to 1000 rpm
50 L0 to 180 rpm0 to 1000 rpm

Integrated peristaltic pumps (additions)

Typical

The equipment typically includes 4 integrated variable-speed peristaltic pumps for sterile additions (acid/base/antifoam/feeds). Actual flow depends on selected tubing and calibration.

Parameter Typical value Notes
Quantity 4 units (integrated) In control tower; assignment defined by configuration
Speed 0-300 rpm Variable control from eSCADA
Minimum flow 0-10 mL/min Example with 0.8 mm ID tubing; depends on tubing and calibration
Maximum flow Up to ~366 mL/min Example with 4.8 mm ID tubing; actual flow depends on calibration
Operating modes OFF / AUTO / MANUAL / PROFILE AUTO typically associated to pH/DO/foam loops or recipe
Functions PURGE, calibration, totaliser, PWM PWM available for low flow setpoints below minimum operating level

Gas flow control (microbial reference capacity)

Reference

For microbial culture (MB), gas flow controllers (MFC) are typically sized based on VVM targets. Typical reference VVM range: 0.5-1.5 (to be confirmed by process).

Working volume (L) VVM min VVM max Air (L/min) O2 (10%) (L/min) CO2 (20%) (L/min) N2 (10%) (L/min)
100.51.55-150.5-1.51-30.5-1.5
200.51.510-301-32-61-3
300.51.515-451.5-4.53-91.5-4.5
500.51.525-752.5-7.55-152.5-7.5
O2/CO2/N2 values are shown as reference capacities for typical gas blending strategies (10% O2, 20% CO2, 10% N2). Final gas list and ranges depend on process and configuration.

Instrumentation and sensors

Typical

Instrumentation is configurable. The following list describes typical sensors integrated in standard configurations, plus common optional PAT sensors.

Variable / function Typical technology / interface Status (STD/OPT)
Temperature (process/jacket)Pt100 class A RTDSTD
Pressure (vessel/lines)Pressure transmitter (4-20 mA / digital)STD
Level (working volume)Adjustable probeSTD
pHDigital pH sensor (ARC or equivalent)STD
DO (pO2)Digital optical DO sensor (ARC or equivalent)STD
FoamConductive/capacitive foam sensorSTD
Weight / mass balanceLoad cell (integrated in skid)STD
pCO2Digital pCO2 sensor (ARC or equivalent)OPT
Biomass (permittivity)In-line or in-vessel sensorOPT
VCD / TCDIn-situ cell density sensorsOPT (MU)
Off-gas (O2/CO2)Gas analyser for OUR/CEROPT
ORP / RedoxDigital ORPOPT
Glucose / LactatePAT sensorOPT

Automation, software and connectivity

Typical

The platform incorporates TECNIC eSCADA (typically eSCADA Advanced for ePILOT) to operate actuators and control loops, execute recipes and manage process data.

Main software functions
  • Main overview screen with process parameters and trends
  • Alarm management (real-time alarms and historical log) with acknowledgement and comment option
  • Manual/automatic modes for actuators and control loops
  • Recipe management with phases and transitions; parameter profiles (multi-step) for pumps and setpoints
  • Data logging with configurable period and export to CSV; PDF report generation
Common control loops
  • Temperature control (jacket heating/cooling)
  • Pressure control (headspace) with associated valve management
  • pH control via acid/base addition pumps and optional CO2 strategy
  • DO control with cascade strategies (agitation, air, O2, N2) depending on package and configuration
  • Foam control (foam sensor and automatic antifoam addition)
Data integrity and 21 CFR Part 11

Support for 21 CFR Part 11 / EU GMP Annex 11 is configuration- and project-dependent and requires customer procedures and validation (CSV).

Utilities

Reference

Utilities depend on final configuration (e.g., AutoSIP vs External SIP) and destination market (EU vs North America). The following values are typical reference points.

Utility Typical service / configuration Pressure Flow / power Notes
Electrical EU base: 400 VAC / 50 Hz (3~) N/A AutoSIP: 12 kW; External SIP: 5 kW NA option: 480 VAC / 60 Hz; cabinet/wiring per NEC/NFPA 70; UL/CSA as required
Process gases Air / O2 / CO2 / N2 Up to 2.5 bar(g) (36.3 psi) According to setpoint Typical OD10 pneumatic connections; final list depends on package
Instrument air Pneumatic valves Up to 6 bar(g) (87.0 psi) N/A Dry/filtered air recommended
Cooling water Jacket cooling water 2 bar(g) (29.0 psi) 25 L/min (6.6 gpm) 6-10 °C (43-50 °F) typical
Cooling water Condenser cooling water 2 bar(g) (29.0 psi) 1 L/min (0.26 gpm) 6-10 °C (43-50 °F) typical
Steam (External SIP) Industrial steam 2-3 bar(g) (29.0-43.5 psi) 30 kg/h (66 lb/h) For SIP sequences
Steam (External SIP) Clean steam 1.5 bar(g) (21.8 psi) 8 kg/h (18 lb/h) Depending on plant strategy

Compliance and deliverables

Typical

Depending on destination and project scope, the regulatory basis may include European Directives (CE) and/or North American codes. The exact list is confirmed per project and stated in the Declaration(s) of Conformity when applicable.

Scope EU (typical references) North America (typical references)
Pressure equipmentPED 2014/68/EUASME BPVC Section VIII (where applicable)
Hygienic designHygienic design good practicesASME BPE (reference for bioprocessing)
Machine safetyMachinery: 2006/42/EC (until 13/01/2027) / (EU) 2023/1230OSHA expectations; NFPA 79 (industrial machinery) - project dependent
Electrical / EMCLVD 2014/35/EU; EMC 2014/30/EUNEC/NFPA 70; UL/CSA components and marking as required
Materials contactEC 1935/2004 + EC 2023/2006 (GMP for materials) where applicableFDA 21 CFR (e.g., 177.2600 for elastomers) - materials compliance
Software / CSVEU GMP Annex 11 (if applicable)21 CFR Part 11 (if applicable)
Standard documentation package
  • User manual and basic operating instructions
  • P&ID / layout drawings as per project scope
  • Material certificates and finish/treatment certificates (scope dependent)
  • FAT report (if included in contract)
Optional qualification and commissioning services
  • SAT (Site Acceptance Test)
  • IQ / OQ documentation and/or execution (scope agreed with customer)
  • CSV support package for regulated environments (ALCOA+ considerations, backups, time synchronisation, etc.)

Ordering and configuration

Project-based

ePILOT BR is configured per project. To define the right MU/MB package, volumes and options (utilities, sensors, software and compliance), please contact TECNIC with your URS or request the configuration questionnaire.

The information provided above is for general reference only and may be modified, updated or discontinued at any time without prior notice. Values and specifications are indicative and may vary depending on project scope, configuration and applicable requirements. This content does not constitute a binding offer, warranty, or contractual commitment. Any final specifications, deliverables and acceptance criteria will be confirmed in the corresponding quotation, technical documentation and/or contract documents.

Cellular configuration

The cellular configuration of the eLab Advanced is equipped with a pitched-blade impeller designed to support efficient mixing for cell culture processes in both laboratory development and early scale-up. The blade geometry promotes mainly axial flow, helping to distribute gases, nutrients and pH control agents uniformly throughout the vessel while keeping shear stress at a moderate level. This makes it suitable for mammalian, insect and other shear-sensitive cell lines when operated with appropriate agitation and aeration settings. In combination with the vessel aspect ratio and baffle design, the pitched blade supports stable foaming behavior and reproducible oxygen transfer, which is essential when comparing batches or transferring processes between working volumes.

Operators can fine-tune agitation speed to balance oxygen demand and mixing time without excessively increasing mechanical stress on the culture. 

Technical specifications

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Cellular configuration

The cellular configuration of the eLab Advanced is equipped with a pitched-blade impeller designed to support efficient mixing for cell culture processes in both laboratory development and early scale-up. The blade geometry promotes mainly axial flow, helping to distribute gases, nutrients and pH control agents uniformly throughout the vessel while keeping shear stress at a moderate level. This makes it suitable for mammalian, insect and other shear-sensitive cell lines when operated with appropriate agitation and aeration settings. In combination with the vessel aspect ratio and baffle design, the pitched blade supports stable foaming behavior and reproducible oxygen transfer, which is essential when comparing batches or transferring processes between working volumes.

Operators can fine-tune agitation speed to balance oxygen demand and mixing time without excessively increasing mechanical stress on the culture. 

Technical specifications

Models and working volumes

Tank

The ePlus Mixer platform combines an ePlus Mixer control tower with Tank frames and eBag 3D consumables. Tank can be supplied in square or cylindrical configurations (depending on project) to match the bag format.

Tank model Nominal volume Minimum volume to start agitation*
Tank 50 L50 L15 L
Tank 100 L100 L20 L
Tank 200 L200 L30 L
Tank 500 L500 L55 L
*Values based on agitation start interlocks per tank model. Final performance depends on the selected eBag 3D, fluid properties and configuration.

Design conditions and operating limits

Reference

Reference limits are defined for the ePlus Mixer and the Tank. It is recommended to validate the specific limits of the selected eBag 3D and single-use sensors for the customer’s process.

Element Operating pressure Maximum pressure (safety) Maximum working temperature
ePlus Mixer (control tower)ATM0.5 bar(g)90 °C
TankATM0.5 bar(g)45 °C
Jacket (if applicable)N/A1.5 barDepends on utilities / scope
The 0.5 bar(g) limit is associated with the equipment design, the circuit is protected by a safety valve. Confirm final limits on the equipment nameplate and project specification.

Materials and finishes

Typical
  • Control tower housing and frame: stainless steel 304
  • Product-contact metallic hard parts (if applicable): stainless steel 316 (defined in project manufacturing documentation)
  • Non-product-contact metallic parts: stainless steel 304
  • eBag consumable: single-use polymer (supplier dependent, gamma irradiation / sterilisation per specification)
  • Vent filters: PP (polypropylene), per component list
For GMP projects, the recommended documentation package includes material certificates, surface finish certificates (Ra if applicable) and consumable sterility/irradiation certificates.

Agitation system

Magnetic

Non-invasive magnetic agitation, the impeller is integrated in the eBag 3D Mixer format, avoiding mechanical seals. Agitation speed is controlled from the HMI, with start interlocks linked to the tank model and minimum volume.

Reference speed range
  • Typical agitation range: 120 to 300 rpm (configuration dependent)
  • Magnetic drive motor (reference): Sterimixer SMA 85/140, 50 Hz, 230/400 V, 0.18 kW
  • Gear reduction (reference): 1:5
  • Actuation (reference): linear actuator LEYG25MA, stroke 30–300 mm, speed 18–500 mm/s (for positioning)
Final rpm and mixing performance depend on tank size, bag format and process requirements.

Weighing and volume control

Integrated

Weight and derived volume control are performed using 4 load cells integrated in the tank frame legs and a weight indicator. Tare functions are managed from the HMI to support preparation steps and additions by mass.

Component Reference model Key parameters
Load cells (x4) Mettler Toledo SWB505 (stainless steel) 550 kg each, output 2 mV/V, IP66
Weight indicator Mettler Toledo IND360 DIN Acquisition and HMI display, tare and “clear last tare”
For installation engineering, total floor load should consider product mass + equipment mass + margin (recommended ≥ 20%).

Pumps and fluid handling

Standard

The platform includes integrated pumps for additions and circulation. Final tubing selection and calibration define the usable flow range.

Included pumps (reference)
  • 3 integrated peristaltic pumps for additions (acid/base/media), with speed control from HMI
  • 1 integrated centrifugal pump for circulation / transfer (DN25)
Peristaltic pumps (reference)
Parameter Reference Notes
Quantity3 unitsIntegrated in the control tower
Pump headHYB101 (Hygiaflex)Example tubing: ID 4.8 mm, wall 1.6 mm
Max speed300 rpmSpeed control reference: 0–5 V
Max flow (example)365.69 mL/minDepends on tubing and calibration
Centrifugal pump (reference)
Parameter Reference
ModelEBARA MR S DN25
Power0.75 kW
FlowUp to 42 L/min
PressureUp to 1 bar
For circulation and sensor loops, the eBag 3D format can include dedicated ports (depending on the selected consumable and application).

Thermal management (optional jacket)

Optional

Tank can be supplied with a jacket (single or double jacket options). The thermal circuit includes control elements and a heat exchanger, enabling temperature conditioning depending on utilities and project scope.

  • Jacket maximum pressure (reference): 1.5 bar
  • Thermal circuit safety: pressure regulator and safety valve (reference set-point 0.5 bar(g))
  • Heat exchanger (reference): T5-BFG, 12 plates, alloy 316, 0.5 mm, NBRP
  • Solenoid valves (reference): SMC VXZ262LGK, 1", DC 24 V, 10.5 W
  • Jacket sequences: fill / empty / flush (scope dependent)
The tank maximum temperature may depend on the thermal circuit and consumable limits. Confirm final values with the selected eBag 3D specification.

Instrumentation and sensors

Optional SU

Single-use sensors can be integrated via dedicated modules. The following references describe typical sensors and interfaces listed in the datasheet.

Variable Reference model Interface / protocol Supply Operating temperature IP
pH OneFerm Arc pH VP 70 NTC (SU) Arc Module SU pH, Modbus RTU 7–30 VDC 5–50 °C IP67
Conductivity Conducell-P SU (SU) Arc Module Cond-P SU, Modbus RTU 7–30 VDC 0–60 °C IP64
Temperature Pt100 ø4 × 52 mm, M8 (non-invasive) Analog / acquisition module Project dependent Project dependent Project dependent
Measurement ranges and final sensor list depend on the selected single-use components and project scope.

Automation, software and data

Standard + options

The ePlus SUM control tower integrates an industrial PLC and touch HMI. Standard operation supports Manual / Automatic / Profile modes, with optional recipe execution depending on selected software scope.

Software scope (reference)
  • Standard: eBASIC (base HMI functions)
  • Optional: eSCADA Basic or eSCADA Advanced (project dependent)
  • Trends, alarms and profiles, profiles up to 100 steps (depending on scope)
  • Data retention (reference): up to 1 year
Connectivity (reference)
  • Industrial Ethernet and integrated OPC server (included)
  • Remote access option (project dependent)

Utilities and facility interfaces

Typical

Installation requirements depend on jacket and temperature scope and the customer layout. The following values are typical references.

Utility Pressure Flow Connections Notes
Electrical supply N/A Reference: 18 A 380–400 VAC, 3~ + N, 50 Hz Confirm per final configuration and destination market
Ethernet N/A N/A RJ45 OPC server, LAN integration
Tap water 2.5 bar N/A 1/2" (hose connection) Jacket fill and services, tank volume about 25 L
Cooling water 2–4 bar 10–20 L/min 2 × 3/4" (hose connection) Heat exchanger and jacket cooling
Process air 2–4 bar N/A 1/2" quick coupling Used for jacket emptying
Drain N/A N/A 2 × 3/4" (hose connection) For draining
Exhaust N/A N/A N/A Optional (depending on project)
Stack light (optional) N/A N/A N/A 3-colour indication, as per scope
During FAT, verify in the installation checklist that the available utilities match the selected configuration and scope.

Documentation and deliverables

Project-based

Deliverables depend on scope and project requirements. The following items are typical references included in the technical documentation package.

  • Datasheet and user manual (HMI and system operation)
  • Electrical schematics, PLC program and backup package (scope dependent)
  • P&ID, layout and GA drawings (PDF and/or CAD formats, project dependent)
  • Factory Acceptance Test (FAT) protocol and FAT report (as per contract)
  • Installation checklist
  • Material and consumable certificates, as required for regulated projects (scope dependent)
On-site services (SAT, IQ/OQ) and extended compliance packages are optional and defined per project.

Ordering and configuration

Contact

The ePlus Mixer scope is defined per project. To select the right tank size, bag format, sensors and optional jacket and software, please share your URS or request the configuration questionnaire.

The information provided above is for general reference only and may be modified, updated or discontinued at any time without prior notice. Values and specifications are indicative and may vary depending on project scope, configuration and applicable requirements. This content does not constitute a binding offer, warranty, or contractual commitment. Any final specifications, deliverables and acceptance criteria will be confirmed in the corresponding quotation, technical documentation and/or contract documents.

Operating windows microbial vs. cell culture

The operating range depends on the volume, gas configuration and impeller type. Typical performance references and operating parameters for both applications are summarised below (guideline values; final performance depends on medium, antifoam, geometry and aeration strategy).

Performance and parameters:

Indicative operating windows for cellular and microbial processes. Final values depend on bag configuration, impellers, aeration strategy and process targets.

Application

Cell culture

Agitation (rpm)

300: 0–450
1000: 0–300

Tip speed (m/s)

0.4–1.8

P/V (W/m³)

80–200

kLa (h⁻¹)

20–30

Application

Microbial

Agitation (rpm)

300: 0–450
1000: 0–300

Tip speed (m/s)

1.5–5.0

P/V (W/m³)

1,000–5,500

kLa (h⁻¹)

150–330

Typical gas line ranges by model and application. Installed ranges and gas setup depend on selected options and project scope.

Gas

Process air

Typical range (Ln/min)

300 L: 20–300 (up to 600 depending on configuration)
1000 L: 20–1000 (up to 2000 depending on configuration)

Main use

Aeration by sparger / mixing

Notes by application

Microbial: primary. 

Cellular: DO support.

Gas

Oxygen (O₂)

Typical range (Ln/min)

300 L: 2–30 (up to 600 depending on configuration)
1000 L: 2–100 (up to 2000 depending on configuration)

Main use

DO enrichment and cascade

Notes by application

Microbial: frequent. Cellular: cascade at DO set point.

Gas

Carbon dioxide (CO₂)

Typical range (Ln/min)

300 L: 2–30 (typical) / 10–150 (depending on configuration)
1000 L: 2–100 (typical) / 10–500 (depending on configuration)

Main use

pH control / CO₂ balance

Notes by application

Cellular: standard. Microbial: optional.

Gas

Overlay (air or O₂)

Typical range (Ln/min)

300 L: 10–150
1000 L: 10–500

Main use

Headspace scavenging / gas control

Notes by application

Cellular: standard. Microbial: optional.

Note: the exact flow and gas ranges installed depend on the model and the options purchased.

 

Multi Use Bioreactors

Single Use Bioreactors

Multi Use TFF Systems

Single Use TFF Systems

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Designed to enhance our bioprocess solutions

Versatile and reliable bioreactor vessels for bioprocessing

Versatile and reliable bioreactor vessels for bioprocessing