Lifecask™ RG Single-Use Bioreactor Bags
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Cobetter Lifecask™ RG single-use bioreactor bags aim to offer reliable upstream process solution for bio-pharmaceutical companies. The scale ranges from 50L to 2000L, covering the requirement from lab to manufacturing process. Our unique, patented split aeration disk design has been confirmed to satisfy the oxygen requirement at each scale.
Comparing with stainless steel system, the use of Lifecask™ RG single-use bioreactor bags free from complex and time-costing SIP and CIP, which make them an easier and more time-saving solution for upstream process. The RG bioreactor bags are made of our own Lifemeta™ KA film, features low extractables and good mechanical performance, which makes them ideal for cell culture. Multiple kinds of tubings and ports are designed to satisfy each single stage of cell culture including probe installation, cell inoculation, sampling, feeding, and harvesting. Single-use pressure sensor and back-up filter port are designed to minimize the risk of bag breakage, thus guarantee safe running of cell culture process.
Specifications
| Size | 50L | 200L | 500L | 1000L | 2000L |
| Max. WV(L) | 50 | 200 | 500 | 1000 | 2000 |
| Min. WV(L) | 22 | 40 | 100 | 200 | 400 |
| Turn down ratio | 2.2:1 | 5:1 | 5:1 | 5:1 | 5:1 |
| H/D | 2.25:1 | 1.5:1 | 1.5:1 | 1.5:1 | 1.5:1 |
| Typical Container | 304 Stainless steel | ||||
| Filter heating assembly | 1 | 1 | 1 | 1 | 1 |
| Other filter heating assembly (Optional) | 1 | 1 | 1 | 1 | 1 |
| pH Ports | 1 | 2 | 2 | 2 | 2 |
| DO Ports | 1 | 2 | 2 | 2 | 2 |
Suitable for Multiple Cultivation Applications
Lifecask™ RG single-use bioreactor bags can be applied to multiple fields (antibody, vaccine and CGT，etc.) and different kinds of cell culture process such as suspension cell culture (CHO, HEK293, BHK21, Hybridoma or SF9, etc.) and adherent cell culture (Vero, HEK293T, hMSC, etc.). Our single-use bioreactor bags are available in multiple sizes and configurations and can be customized to satisfy the requirement of special process such as high CO2 stripping, low shear stress and high cell density cell culture.
Fully Self-Produced Components
Cobetter Lifecask™ RG single-use bioreactor bags are manufactured fully with our self-produced components, including:
- Lifemeta™ KA Film
- Lifemeta™ STT Silicone Tubing
- Lifemeta™ STF TPE Tubing
- Bricap™ Capsule Filters
- Lifecube™ AS Sampling Bags
- Lifemeta™ Bioreactor Probe Sleeve
| Cart No. | Description | Probe Type | QTY (pcs/pk) |
| SAL30178 | Kleenpak™ Aseptic Male Connector + Bioreactor Probe Sleeve + Thread Electrode Port + Clamp | Thread PG13.5, Length 225mm, OD12mm | 4 |
| SAL30179 | Kleenpak™ Aseptic Male Connector + Bioreactor Probe Sleeve + Thread Electrode Port | Thread PG13.5, Length 225mm, OD12mm | 1 |
Accelerating R&D to Commercialization - Backed by Strong Scalability Data
Lifecask™ RG Single-Use Bioreactor Bags are designed to ensure smooth scaling-up from R&D to commercialization through a series of considerations with the following key features:
1) Design based on geometric similarity. The bags are designed with an H/D aspect ratio of 1.5:1 to ensure similarity in fluid flow patterns. All series of bags are configured with three options of aeration pore sizes (20μm, 0.5mm and 1mm). The impellers are bottom-mounted with a 40° angle. Through components optimization and similarity design, it ensures similar gas exchange and mass transfer among different scales of bags.
2) Full performance validation for process scaling-up. Lifecask™ RG single-use bioreactor bags have undergone comprehensive performance validation. Cobetter has conducted parameter measurements and validation including mixing time, kLa modeling and Newton Power analysis. CFD modeling for fluid analysis was also used to provide reliable performance data to support the users’ process scaling-up.
3) Safety considerations increase the success rate of tech-transfer. Lifecask™ RG single-use bioreactor bags are supplied with integrated single-use pressure sensors for real-time monitoring of the in-bag pressure during the cell culture process. The standard product is also equipped with an outlet filter port to meet the air exchange requirements of high throughput processes, minimizing the risk of bag leakage and contamination. We also offer optional single-use polarographic/optical probes, which could eliminates the need for probe installation to reduce operational risks. The bags and filters are subjected to a strict delivery integrity test, which guarantees the safety of cell culture process from small to large scale.
Comprehensive Configurations for Full Upstream Process Coverage Flexibility and Configurations.
Cobetter Lifecask™ RG single-use bioreactor bags come standard with Lifemeta™ KA film as well as its self-manufactured LifemetaTM STT silicone tubing and Lifemeta™ STF TPE tubing. Bag sampling ports are available for easy sampling solutions such as needle-free samplers or multi-sampling bag assemblies. Meanwhile, Cobetter accepts customized requirements such as Renolit 9101 film and other types of tubings and fittings in a variety of sizes. For example, for perfusion culture process, the bags can be equipped with single-use aseptic connectors, which are convenient for connecting with hollow fiber products. The aeration disks can be adjusted as needed or customized with other numbers and sizes as required by the process.
Easy Implementation. Cobetter Lifecask™ RG single-use bioreactor bags are packed in a double-layer sterile package that is ready-to-use for simple handling and short installation time. Ventilation filters are directly connected with the bag, which eliminates the need for connecting at site and reduces complicated operational steps.
A Complete Single-Use Portfolio. Cobetter offers aseptic connection and disconnection solutions. We provide self-produced aseptic tube welder/sealer or aseptic connectors for the transfer of cells, media or feed solution. Besides, Cobetter provides bag integrity tester to ensure the safety of cell culture bags and liquid storage bags before use (for more details, please consult Cobetter sales or technical support). For high-density perfusion cell culture, Cobetter can provide hollow fiber products and related controller. For intensive process, Cobetter provides Lifecask™ RW disposable wave bioreactor bags with cell retention membrane as the first choice, which allows direct seed supply from 20L culture scale to 2000L single-use system.
Systematic Validation Ensures Robust Process
Cobetter Lifecask™ RG single-use bioreactor bags have undergone in-depth extractable analysis, chemical compatibility analysis, physical property validation, cytotoxicity validation and product performance validation. We can provide customers with various validation documents including validation guides, extractable reports, application notes, etc.
High Standard Quality Management System and Stable Supply Security
Quality Assurance: Cobetter LifecaskTM RG single-use bioreactor bags are manufactured by following stringent processes and quality control standards. The production process is carried out in accordance with the ISO9001-2015 quality management system and is all done under ISO Class 7 to ensure the cleanliness of the product. Quality documentation including MSDS, COA, and TSE/BSE Free declaration can be provided to help biopharmaceutical customers' safe production and audit requirements.
Quality Assurance
- ISO 9001:2015 quality management system
- ISO7 class 7 manufacturing site
- 100% bag integrity test
- ADCF raw material，meets the requirement of FDA 21CFR177-182 indirect food additives
- Meets the requirement of ISO 11137 sterilization validation
- Meets the requirement of USP <87> in Vitro Biological Reactivity Test
- Meets the requirement of USP <88> Biological Reactivity Test, in Vivo for Class VI plastics
- Aqueous extraction contains < 0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL), USP <85>
- Particulate matter in the product eluent meets the requirement in USP <788> for large volume parenterals
- Product validation guide and COA available
Security of Supply: At present, Cobetter has 11 production lines of single-use bags and 1 ISO Class 5 production line of final filling bags, providing more than one million single-use bags annually to global customers. In 2022, Cobetter introduced the world-leading single-use film processing co-extruding machine and signed a long-term strategic partnership with raw material suppliers to guarantee the control of the entire production flow from raw materials traceability, and components optimization to final product assembly.
Global Distribution and Quick Response
As a supplier actively promoting the global presence of biopharmaceutical single-use products, Cobetter serves global customers in 108 countries, providing product introduction, technical training support, pre&post sales services and process equipment solutions. Cobetter's strong and professional single-use application team and service engineer team can provide timely product consultation, process solutions and customer complaints handling.
Customer-first principles, good quality control and excellent design concepts are the cornerstone of business development of single-use bioreactor bags and empower Cobetter to continuously provide reliable, diversified, and flexible upstream process solutions for worldwide users.
Please contact local Cobetter sales or technical support for more product information.