Description
Key Features
Specifications
Storage & Handling
FAQs
Product Description
The Cell Factory system is a scalable, closed large-port cell factory platform designed for the production of human and animal vaccines, therapeutic proteins, cell therapy products, and gene therapy products. Available in 1, 2, 4, 10, and 40-layer configurations, the system provides a seamless path from manual R&D operations to large-scale closed production without changing workflow or equipment.
Each unit is constructed from TC-treated polystyrene chambers assembled using ultrasonic welding technology — eliminating the adhesive and solvent bonding used by competing products. The adhesive-free construction removes potential contamination sources and improves structural integrity across the full growth surface area.
The standard large-port design facilitates rapid liquid perfusion, draining, and balancing across all layers simultaneously, while providing enhanced ventilation conditions for optimal cell culture performance. Compatible with standard MPC tube assembly accessories for closed system operation.
Available Layer Configurations:
1
Layer
632 cm²
335×205×36 mm
2
Layers
1,264 cm²
335×205×53 mm
4
Layers
2,526 cm²
335×205×87 mm
10
Layers
6,316 cm²
335×205×189 mm
40
Layers
25,265 cm²
335×205×698 mm
Key Features & Benefits
- Scalable 1 to 40-layer configurations — seamlessly scale from 632 cm² (1-layer R&D) to 25,265 cm² (40-layer production) without changing workflow, reagents, or operational procedures
- Standard large-port design — facilitates rapid liquid perfusion, complete draining, and balanced media distribution across all layers simultaneously — reducing handling time and contamination risk
- No adhesive or solvent construction — polystyrene chambers are assembled using ultrasonic welding — eliminating glue and solvent-based bonding that can leach contaminants into culture media
- TC-treated polystyrene surface — tissue culture treated growth surface for reliable adherent cell attachment and monolayer formation across all layers
- Closed system compatibility — standard large-port design compatible with MPC tube assembly accessories for fully closed liquid handling — supporting GMP and biosafety requirements
- Seamless R&D to production transition — standard port design allows customers to switch between manual R&D operations and large-scale closed production without process changes
- Suitable for regulated production applications — designed for vaccine production, therapeutic protein expression, cell therapy, and gene therapy manufacturing workflows
- DNase/RNase, Endotoxin, Human DNA, ATP, and Pyrogen-free — certified for sensitive biological production applications
- Sterile — SAL 10⁻⁶, manufactured under ISO 13485, meets USP Class VI requirements
⚠️ Not autoclavable — single-use only. Do not attempt to re-sterilize or reuse. Each unit is pre-sterilized and certified contaminant-free from the factory.
Specifications
| Specification | Detail |
|---|---|
| Material | TC-treated polystyrene chambers |
| Assembly Method | Ultrasonic welding — no adhesive or solvent |
| Port Design | Standard large-port for rapid perfusion and drainage |
| Growth Surface Treatment | TC-treated — optimized for adherent cell attachment |
| Available Configurations | 1-layer | 2-layer | 4-layer | 10-layer | 40-layer |
| 1-Layer Growth Area | 632 cm² | 335 × 205 × 36 mm |
| 2-Layer Growth Area | 1,264 cm² | 335 × 205 × 53 mm |
| 4-Layer Growth Area | 2,526 cm² | 335 × 205 × 87 mm |
| 10-Layer Growth Area | 6,316 cm² | 335 × 205 × 189 mm |
| 40-Layer Growth Area | 25,265 cm² | 335 × 205 × 698 mm |
| Case Quantity — 1 to 10 Layer | 6 units per case |
| Case Quantity — 40 Layer | 2 units per case |
| Autoclavable | ⚠️ Not Autoclavable — single-use |
| Sterile | ✓ Yes — pre-sterilized |
| Sterility Assurance Level | SAL 10⁻⁶ |
| Quality System | Manufactured under ISO 13485 |
| Biocompatibility | Meets USP Class VI requirements |
| RNase / DNase-free | ✓ Certified |
| Endotoxin-free | ✓ Certified |
| Human DNA-free | ✓ Certified |
| Pyrogen-free | ✓ Certified |
| ATP-free | ✓ Certified |
| Applications | Vaccine production, therapeutic proteins, cell therapy, gene therapy |
⚠️ Vendor to confirm: working volume per layer, port connection type, and vent filter specifications. Update this section once confirmed.
Storage & Handling
- Store in original packaging in a clean, dry environment away from direct sunlight and UV exposure
- Maintain storage temperature between 15°C and 30°C (59°F – 86°F)
- Keep away from excessive humidity
- Do not use units from damaged or previously opened packaging
- Handle using standard GMP aseptic technique — open and set up inside a biosafety cabinet or laminar flow hood
- Connect MPC tube assembly accessories using aseptic technique before introducing culture media
- Inspect unit for damage before use — do not use units showing cracks, deformation, or seal compromise
- Single-use only — do not reuse between culture runs
- Dispose of used units in accordance with your institution's biosafety and regulatory waste disposal requirements
⚠️ Single-use only — not autoclavable. Do not reuse between culture runs. For regulated production applications, follow your facility's validated SOPs for cell factory setup, operation, and disposal.
Frequently Asked Questions
How do I choose the right layer configuration?
Layer selection depends on your required cell yield and production scale. The 1-layer (632 cm²) unit is suitable for R&D, process development, and small-scale production. The 2 and 4-layer units bridge R&D and pilot scale. The 10-layer (6,316 cm²) unit is the most common production choice for mid-scale manufacturing. The 40-layer (25,265 cm²) unit is designed for large-scale production of vaccines, therapeutic proteins, and cell therapy products. Because all configurations use the same standard large-port design, processes developed on 1-layer units scale directly to 40-layer production without protocol changes.
What is the advantage of ultrasonic welding vs adhesive assembly?
Competing cell factory products are assembled using adhesive or solvent-based bonding — these materials can leach low levels of contaminants into culture media over time, potentially affecting cell viability, product quality, and analytical results. Ultrasonic welding creates a direct polymer-to-polymer bond with no added materials, eliminating the risk of adhesive or solvent leaching entirely. This is particularly important for GMP-regulated vaccine and biologic production where extractable and leachable profiles must meet strict regulatory standards.
What does the standard large-port design offer?
The standard large-port design provides oversized ports for rapid liquid perfusion, complete media drainage, and balanced liquid distribution across all layers simultaneously. This reduces the time required for media changes, seed and harvest operations, and balancing across layers — improving process efficiency especially at larger scale. The large ports also provide better ventilation conditions for gas exchange during culture. The standardized port size is compatible with MPC tube assembly accessories for closed system operation.
Can I use the same process parameters from R&D to production scale?
Yes — this is a core design principle of the PakGent Cell Factory system. All layer configurations share the same standard large-port design, port dimensions, and surface treatment. Process parameters including seeding density per cm², media volume per cm², feed schedules, and harvest procedures developed on the 1-layer R&D unit translate directly to the 10 and 40-layer production units without requiring revalidation of the core culture process.
What accessories are required for closed system operation?
Closed system operation requires MPC tube assembly accessories — available separately. To connect the Cell Factory system to a media bottle, use a tubing set with a Cell Factory system connector on one end and an MPC insert on the other end, placing the Cell Factory connector on the second port. Options include C-Flex and silicone tube assemblies with 1/4" or 3/8" MPC fittings, 0.22 µm butterfly and bag filters for vent and liquid transfer filtration, and MPC quick connector assemblies. See the Cell Factory Accessories product page for the complete accessory range.
Are Certificates of Analysis available?
Yes — Certificates of Analysis (COA) are available upon request for all Cell Factory units. Each lot is tested and certified RNase-, DNase-, Endotoxin-, Human DNA-, ATP-, and Pyrogen-free, manufactured under ISO 13485, and meets USP Class VI biocompatibility requirements. Contact us with your lot number for documentation.
Description
Key Features
Specifications
Storage & Handling
FAQs
Product Description
The Cell Factory system is a scalable, closed large-port cell factory platform designed for the production of human and animal vaccines, therapeutic proteins, cell therapy products, and gene therapy products. Available in 1, 2, 4, 10, and 40-layer configurations, the system provides a seamless path from manual R&D operations to large-scale closed production without changing workflow or equipment.
Each unit is constructed from TC-treated polystyrene chambers assembled using ultrasonic welding technology — eliminating the adhesive and solvent bonding used by competing products. The adhesive-free construction removes potential contamination sources and improves structural integrity across the full growth surface area.
The standard large-port design facilitates rapid liquid perfusion, draining, and balancing across all layers simultaneously, while providing enhanced ventilation conditions for optimal cell culture performance. Compatible with standard MPC tube assembly accessories for closed system operation.
Available Layer Configurations:
1
Layer
632 cm²
335×205×36 mm
2
Layers
1,264 cm²
335×205×53 mm
4
Layers
2,526 cm²
335×205×87 mm
10
Layers
6,316 cm²
335×205×189 mm
40
Layers
25,265 cm²
335×205×698 mm
Key Features & Benefits
- Scalable 1 to 40-layer configurations — seamlessly scale from 632 cm² (1-layer R&D) to 25,265 cm² (40-layer production) without changing workflow, reagents, or operational procedures
- Standard large-port design — facilitates rapid liquid perfusion, complete draining, and balanced media distribution across all layers simultaneously — reducing handling time and contamination risk
- No adhesive or solvent construction — polystyrene chambers are assembled using ultrasonic welding — eliminating glue and solvent-based bonding that can leach contaminants into culture media
- TC-treated polystyrene surface — tissue culture treated growth surface for reliable adherent cell attachment and monolayer formation across all layers
- Closed system compatibility — standard large-port design compatible with MPC tube assembly accessories for fully closed liquid handling — supporting GMP and biosafety requirements
- Seamless R&D to production transition — standard port design allows customers to switch between manual R&D operations and large-scale closed production without process changes
- Suitable for regulated production applications — designed for vaccine production, therapeutic protein expression, cell therapy, and gene therapy manufacturing workflows
- DNase/RNase, Endotoxin, Human DNA, ATP, and Pyrogen-free — certified for sensitive biological production applications
- Sterile — SAL 10⁻⁶, manufactured under ISO 13485, meets USP Class VI requirements
⚠️ Not autoclavable — single-use only. Do not attempt to re-sterilize or reuse. Each unit is pre-sterilized and certified contaminant-free from the factory.
Specifications
| Specification | Detail |
|---|---|
| Material | TC-treated polystyrene chambers |
| Assembly Method | Ultrasonic welding — no adhesive or solvent |
| Port Design | Standard large-port for rapid perfusion and drainage |
| Growth Surface Treatment | TC-treated — optimized for adherent cell attachment |
| Available Configurations | 1-layer | 2-layer | 4-layer | 10-layer | 40-layer |
| 1-Layer Growth Area | 632 cm² | 335 × 205 × 36 mm |
| 2-Layer Growth Area | 1,264 cm² | 335 × 205 × 53 mm |
| 4-Layer Growth Area | 2,526 cm² | 335 × 205 × 87 mm |
| 10-Layer Growth Area | 6,316 cm² | 335 × 205 × 189 mm |
| 40-Layer Growth Area | 25,265 cm² | 335 × 205 × 698 mm |
| Case Quantity — 1 to 10 Layer | 6 units per case |
| Case Quantity — 40 Layer | 2 units per case |
| Autoclavable | ⚠️ Not Autoclavable — single-use |
| Sterile | ✓ Yes — pre-sterilized |
| Sterility Assurance Level | SAL 10⁻⁶ |
| Quality System | Manufactured under ISO 13485 |
| Biocompatibility | Meets USP Class VI requirements |
| RNase / DNase-free | ✓ Certified |
| Endotoxin-free | ✓ Certified |
| Human DNA-free | ✓ Certified |
| Pyrogen-free | ✓ Certified |
| ATP-free | ✓ Certified |
| Applications | Vaccine production, therapeutic proteins, cell therapy, gene therapy |
⚠️ Vendor to confirm: working volume per layer, port connection type, and vent filter specifications. Update this section once confirmed.
Storage & Handling
- Store in original packaging in a clean, dry environment away from direct sunlight and UV exposure
- Maintain storage temperature between 15°C and 30°C (59°F – 86°F)
- Keep away from excessive humidity
- Do not use units from damaged or previously opened packaging
- Handle using standard GMP aseptic technique — open and set up inside a biosafety cabinet or laminar flow hood
- Connect MPC tube assembly accessories using aseptic technique before introducing culture media
- Inspect unit for damage before use — do not use units showing cracks, deformation, or seal compromise
- Single-use only — do not reuse between culture runs
- Dispose of used units in accordance with your institution's biosafety and regulatory waste disposal requirements
⚠️ Single-use only — not autoclavable. Do not reuse between culture runs. For regulated production applications, follow your facility's validated SOPs for cell factory setup, operation, and disposal.
Frequently Asked Questions
How do I choose the right layer configuration?
Layer selection depends on your required cell yield and production scale. The 1-layer (632 cm²) unit is suitable for R&D, process development, and small-scale production. The 2 and 4-layer units bridge R&D and pilot scale. The 10-layer (6,316 cm²) unit is the most common production choice for mid-scale manufacturing. The 40-layer (25,265 cm²) unit is designed for large-scale production of vaccines, therapeutic proteins, and cell therapy products. Because all configurations use the same standard large-port design, processes developed on 1-layer units scale directly to 40-layer production without protocol changes.
What is the advantage of ultrasonic welding vs adhesive assembly?
Competing cell factory products are assembled using adhesive or solvent-based bonding — these materials can leach low levels of contaminants into culture media over time, potentially affecting cell viability, product quality, and analytical results. Ultrasonic welding creates a direct polymer-to-polymer bond with no added materials, eliminating the risk of adhesive or solvent leaching entirely. This is particularly important for GMP-regulated vaccine and biologic production where extractable and leachable profiles must meet strict regulatory standards.
What does the standard large-port design offer?
The standard large-port design provides oversized ports for rapid liquid perfusion, complete media drainage, and balanced liquid distribution across all layers simultaneously. This reduces the time required for media changes, seed and harvest operations, and balancing across layers — improving process efficiency especially at larger scale. The large ports also provide better ventilation conditions for gas exchange during culture. The standardized port size is compatible with MPC tube assembly accessories for closed system operation.
Can I use the same process parameters from R&D to production scale?
Yes — this is a core design principle of the PakGent Cell Factory system. All layer configurations share the same standard large-port design, port dimensions, and surface treatment. Process parameters including seeding density per cm², media volume per cm², feed schedules, and harvest procedures developed on the 1-layer R&D unit translate directly to the 10 and 40-layer production units without requiring revalidation of the core culture process.
What accessories are required for closed system operation?
Closed system operation requires MPC tube assembly accessories — available separately. To connect the Cell Factory system to a media bottle, use a tubing set with a Cell Factory system connector on one end and an MPC insert on the other end, placing the Cell Factory connector on the second port. Options include C-Flex and silicone tube assemblies with 1/4" or 3/8" MPC fittings, 0.22 µm butterfly and bag filters for vent and liquid transfer filtration, and MPC quick connector assemblies. See the Cell Factory Accessories product page for the complete accessory range.
Are Certificates of Analysis available?
Yes — Certificates of Analysis (COA) are available upon request for all Cell Factory units. Each lot is tested and certified RNase-, DNase-, Endotoxin-, Human DNA-, ATP-, and Pyrogen-free, manufactured under ISO 13485, and meets USP Class VI biocompatibility requirements. Contact us with your lot number for documentation.
Frequently Bought Together
These other products might interest you