Viral Vectors & VLPs: 2 Essential Breakthroughs in Medicine

Researchers worldwide are diligently developing and applying new technologies related to viral vectors, Virus-like particles and AAVs. These advancements could transform the battle against many diseases, bringing fresh hope for health and well-being.

Harnessing viral vectors and virus-like particles for groundbreaking therapies

Researchers around the world are ardently working on the development and application of innovative technologies related to viral vectors, VLPs, and adeno-associated vaccines (AAVs). These advancements promise to revolutionize the fight against a broad range of diseases, offering new hope for human health and well-being.

Viral vectors play a crucial role in gene therapy, acting as genetic material carriers to specific cells. The last decade has shown great progress in viral vector development, especially AAVs. These safe vectors effectively deliver genes, showing promise in treating various genetic diseases.

VLPs resemble viruses but lack infectious DNA, making them a reliable choice for vaccine development. They trigger robust, specific immune responses without infection risks. Research now aims to use VLPs against viral and bacterial diseases, and even cancer.

AAVs are gaining recognition for inducing durable, safe immune responses. These harmless viruses carry a pathogen's genetic material into the body. Once inside, they instruct immune cells to produce proteins that fight the pathogen. This method is promising for preventing infections and managing chronic conditions.

The mix of viral vectors, VLPs, and AAVs is leading to safer, more effective vaccines and treatments for various diseases. Key focus areas include:

Vaccines against infectious diseases
Gene Theraphy
Oncology

Challenges like optimizing production and controlling dosages exist, but the future shines bright for viral vectors, VLPs, and AAVs technologies. These innovations are leading us to a medical era where we might prevent, treat, and possibly eradicate diseases.

The scientific community's ongoing support and technological progress are crucial. They are expected to significantly impact global health and address severe diseases.

Tecnic's bioreactors: Catalyzing the large-scale production of revolutionary vaccines and therapies

Producing viral vectors, VLPs, and AAVs on an industrial scale is challenging. It demands specialized bioprocessing equipment and advanced technologies. Meeting global demand for these therapies and vaccines turns production into a precise, strictly regulated process.

Bioreactors play a key role in large-scale production, controlling cell growth and expansion. Tecnic's bioreactors excel in the industry, crafted with the latest technology and precision. They meet the unique demands of producing virus-like particles and AAVs.

However, beyond bioreactors, we also need to implement advanced purification technologies. These technologies are crucial for separating and concentrating the target molecules from cells and other components in the culture media. Our purification processes can encompass chromatography, filtration, precipitation, and other specialized techniques.

At Tecnic, we appreciate that industrial production is a complex, interdisciplinary endeavor. We closely collaborate with scientists, engineers, and regulatory specialists to ensure our bioreactor solutions and process technologies adhere to the most stringent standards. This collaboration ensures the wide availability of these promising technologies to meet global health demands.

With our dedication to technological advancement and continuous process improvement, we aim for Tecnic's products to be instrumental in combating diseases and enhancing the quality of life globally.

Viral Vectors & VLPs FAQ

Frequently Asked Questions (FAQ)

What are viral vectors?

Modified viruses used to deliver genes into cells for therapy.

What are VLPs?

Virus-like particles that trigger immune responses without causing infection.

What is the main difference between viral vectors and VLPs?

Viral vectors are used for gene delivery into cells, while VLPs are primarily used in vaccines to stimulate immunity without altering genetic material.

What challenges exist in viral vector and VLP production?

Scaling up production while ensuring purity, safety, and process reproducibility are key challenges, requiring advanced bioprocessing technologies.

Why are VLPs important for vaccines?

They safely mimic viruses to boost immunity.

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Cassette

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.

Contact General

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.

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

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
ModeElementWorking 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 volumeMU (Cell culture), referenceMB (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.

ParameterTypical valueNotes
Quantity4 units (integrated)In control tower; assignment defined by configuration
Speed0-300 rpmVariable control from eSCADA
Minimum flow0-10 mL/minExample with 0.8 mm ID tubing; depends on tubing and calibration
Maximum flowUp to ~366 mL/minExample with 4.8 mm ID tubing; actual flow depends on calibration
Operating modesOFF / AUTO / MANUAL / PROFILEAUTO typically associated to pH/DO/foam loops or recipe
FunctionsPURGE, calibration, totaliser, PWMPWM 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 minVVM maxAir (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 / functionTypical technology / interfaceStatus (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.

UtilityTypical service / configurationPressureFlow / powerNotes
ElectricalEU base: 400 VAC / 50 Hz (3~)N/AAutoSIP: 12 kW; External SIP: 5 kWNA option: 480 VAC / 60 Hz; cabinet/wiring per NEC/NFPA 70; UL/CSA as required
Process gasesAir / O2 / CO2 / N2Up to 2.5 bar(g) (36.3 psi)According to setpointTypical OD10 pneumatic connections; final list depends on package
Instrument airPneumatic valvesUp to 6 bar(g) (87.0 psi)N/ADry/filtered air recommended
Cooling waterJacket cooling water2 bar(g) (29.0 psi)25 L/min (6.6 gpm)6-10 °C (43-50 °F) typical
Cooling waterCondenser cooling water2 bar(g) (29.0 psi)1 L/min (0.26 gpm)6-10 °C (43-50 °F) typical
Steam (External SIP)Industrial steam2-3 bar(g) (29.0-43.5 psi)30 kg/h (66 lb/h)For SIP sequences
Steam (External SIP)Clean steam1.5 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.

ScopeEU (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

    ePILOT BR configuration questionnaire









    Project details



















    FAT:

    Shipment:

    Installation:

    SAT:

    IQ/OQ:


    Process and automation requirements























    MU only (cell culture)


    MB only (microbial)


    Utilities and infrastructure



    North America specific















    Connections, consumables and compliance












    EU specific




    North America specific


    Software / CSV (GMP)


    Validation, testing and documentation










    GMP / CSV


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    Additional comments