Product Overview
CELLIPOWER06 is a basket-type bioreactor specifically designed for adherent cell culture supported by sheet-type carriers (fiber disks). By retaining cells within fibrous disk carriers, the system minimizes shear stress and bubble-induced damage to the greatest extent. It is suitable for adherent culture of animal and insect cells, particularly for large-scale production of viral vaccines, recombinant proteins, and viral vectors. The system has been successfully applied at the 400 L industrial scale for Vero, MDCK, and CHO cell cultures.
Core Technical Advantages
Sheet-Type Fixed Bed Design
Utilizes honeycomb-structured high-density growth matrices (such as Fibra-Cel® Disks or DISKS carriers), providing an ultra-high specific surface area (approximately 1200 cm²/g). This enables cells to grow as monolayers within the carrier structure, significantly improving cell density and culture efficiency.
Minimized Shear Stress
The basket-type fixed bed design secures the carriers within the bioreactor, completely preventing contact between cells and the impeller. Shear stress is reduced to a minimum, with cell viability exceeding 95%. Particularly suitable for shear-sensitive cells such as Vero, MDCK, and CHO.
High Cell Density and Stability
Cells firmly attach within the carrier matrix and are less likely to detach, enabling long-term stable culture (>7 days). This significantly improves product yield while reducing host cell DNA levels in the harvest.
Industrial-Scale Validation
Successfully applied in 400 L vaccine and recombinant protein production, including Vero cell rabies vaccine, CHO cell EPO production, and MDCK cell avian influenza vaccine.
Modular Engineering Design
Supports online CIP/SIP cleaning and sterilization, optional automatic carrier loading/unloading systems, and sterilization cold spot monitoring to meet GMP requirements.
Remote Monitoring Capability
Fully integrated with SCADA systems for real-time data recording and remote control, ensuring process consistency across multiple batches and production sites.
Viral Vaccine Production
Vero Cells: Rabies vaccine, inactivated polio vaccine (IPV), porcine epidemic diarrhea vaccine, hemorrhagic fever with renal syndrome vaccine, classical swine fever vaccine
MDCK Cells: Avian influenza vaccine
BSR Cells: Veterinary rabies vaccine
Diploid Cells: Human rabies vaccine (diploid origin)
Recombinant Protein Expression
CHO Cells: Erythropoietin (EPO)
Vero Cells: Other recombinant proteins
Continuous Perfusion Culture
Supports continuous perfusion for up to 35 days with stable cell density and low residual host cell DNA levels.
Scale-Up and Manufacturing
Suitable for full-scale validation from laboratory to industrial production, including pilot-scale sample preparation and large-scale commercial manufacturing.
Technical Specifications
Working Volume
20–400 L
Carrier Type
Polyester fiber disk carriers (available in different pore sizes and thicknesses)
Recommended Carrier Loading
30 g/L
Agitation Control
50–300 rpm, magnetically driven
DO Control
0–100%, ±1% (via mass flow controller gas mixing)
Temperature Control
5–65°C, ±0.1°C
Dissolved Oxygen (DO)
40%, ±2%, supports O₂/N₂/air mixing
pH Control
2–12, ±0.01, equipped with automatic alkali/CO₂ feeding system
Aeration System
Deep sparging, 0.3–2 vvm
Feeding System
4 controllers, each supporting up to 6 high-precision peristaltic pumps
Maximum Cell Density
Up to 4.5 × 10⁷ cells/mL
Sterilization Method
SIP (Sterilization in Place)
Material
316L stainless steel (USP Class VI compliant)
Certifications
FDA 21 CFR Part 11, GMP
Control System
Distributed architecture with multi-level user access management and audit trail functionality
Successful Case Studies
Vero Cell Rabies Vaccine
At 400 L scale, achieved >98% cell viability and a viral titer of 1.2 × 10⁶ FFU/mL.
CHO Cell EPO Production
Achieved stable 35-day production under continuous perfusion mode, with >90% glycosylation consistency.
MDCK Cell Avian Influenza Vaccine
At 400 L scale, achieved yields of 5 × 10⁸ TCID₅₀/mL with residual host cell DNA <10 pg/mL.
Diploid Cell Rabies Vaccine
Achieved high-purity vaccine production with low host DNA residue supported by sheet-type carriers.
Technical Supplement
Working Principle of the Sheet-Type Carrier (Fiber Disk) Bioreactor
The sheet-type carrier bioreactor (also known as a basket-type bioreactor) immobilizes cells within honeycomb-structured high-density growth matrices such as Fibra-Cel® Disks or DISKS carriers. This provides a static growth environment similar to roller bottle culture while overcoming the scale-up limitations of traditional roller systems.
These carriers are made of polyester fiber and polypropylene, with a single-layer thickness of approximately 0.44 mm and a pore size of approximately 15 μm. With a very high specific surface area (around 1200 cm²/g), they support monolayer cell growth within the carrier matrix. During cultivation, carriers are secured within the basket structure inside the reactor, preventing direct contact between cells and the impeller, thereby minimizing shear stress and achieving cell viability above 95%.
Scale-Up Strategy
The scale-up strategy differs significantly from conventional stirred-tank reactors:
Fixed Bed Structural Design
Carrier loading remains constant to ensure uniform cell distribution within the matrix.
Low-Shear Agitation Optimization
During industrial scale-up, agitation speed is adjusted according to carrier type and density, typically maintained at 50–150 rpm to prevent excessive disturbance.
Aeration Optimization
Deep microbubble sparging is used to avoid direct bubble impact on carriers and ensure uniform dissolved oxygen distribution.
Continuous Perfusion Support
The basket-type fixed bed retains cells and carriers, enabling stable continuous culture for up to 35 days and significantly improving product yield.
Modular Design
Supports linear scale-up from laboratory to industrial production while maintaining consistent hydrodynamic and mass transfer characteristics.
Process Advantages
Minimized Shear Stress
The fixed-bed sheet-type carrier design completely isolates cells from the impeller, making it ideal for shear-sensitive cells such as Vero, MDCK, and CHO.
High Cell Density and Stability
Cells embedded within carriers are less likely to detach, allowing long-term stable culture (>7 days) and significantly higher yields.
Host Cell DNA Control
The carrier-based cell immobilization mechanism reduces cell shedding and lowers residual host cell DNA in the harvest, meeting WHO and Chinese Pharmacopoeia requirements of ≤100 pg/dose for vaccine products.
Process Flexibility
Supports batch, fed-batch, and continuous perfusion modes, especially suitable for viral vector and secreted protein production.
Industrial Validation
Successfully validated at 400 L scale for multiple products, including CHO-derived EPO, Vero cell rabies vaccine, and MDCK cell avian influenza vaccine.
Carrier Pretreatment and Usage Procedure
Carrier Soaking
Fully immerse fiber disk carriers in Water for Injection (WFI) or purified water until completely wetted.
pH Equilibration
Rinse with purified water until the pH is close to that of purified water.
Sterilization
Load carriers into the bioreactor, add PBS solution, and sterilize at high temperature for 30 minutes.
Sterility Testing
After cooling, drain PBS and fill with culture medium for 48-hour sterility testing.
Cell Inoculation
Typical inoculation density is 3–5 × 10⁵ cells/mL. Medium clarification can be observed approximately 30 minutes after inoculation.
Normal Culture
Transition to standard culture conditions for cell expansion and target product production.
Industrial Application ProspectsVaccine Production
Meets global demand for high-quality, cost-effective vaccines, including rabies, IPV, and avian influenza vaccines.
Recombinant Protein Expression
Particularly suitable for high-value CHO-expressed recombinant proteins such as EPO.
Viral Vector Manufacturing
Supports large-scale production of AAV, adenovirus, and other viral vectors for gene therapy applications.
Cell Therapy
Applicable for expansion of therapeutic cells such as mesenchymal stem cells (MSCs), supporting advancements in regenerative medicine.
Continuous Manufacturing
Enables continuous perfusion processes that significantly improve productivity and product quality while reducing manufacturing costs.
