Benchtop Fermenters and Bioreactors System

In Touch with Biotechnology

• Design for easy use and maintenance.
• Apply various functions to enable multi-purpose culture experiments
• User-friendly control display configuration.

Main features are:

• Compact design for various culture experiments even in a small space laboratory
• Apply self-diagnosis system that can record and maintain fermentation process, record and control it in real time
• Configured to enable DO Cascade (dissolved oxygen automatic control) so that various culture experiments are possible.
• Control by easily connecting an external device to the fermenter controller (O₂/CO₂ analyzer, gas mixer, scale, level sensor, external pump, analog printer, etc.)
• Manage all data by configuring a multi-channel network through one PC monitor

Available models: BIOCANVAS LF, BIOTWINstation, BIOCANVAS LF Plus

BIOCANVAS LF and BIOCANVAS LF Plus

Fermenter and Bioreactor Vessel can be customized according to user’s requirements.

Integrated control of 1 to 6 units using a PC control Program

BIOTWINstation

• Single and multi-channel setting to control one or more culture vessels
• Control up to 8CH by one screen
• Secure space by reducing installation space
• Apply 15.6” touch screen applied
• Able to use various vessels ranging from 1L to 13L

There are two main models’ lines: benchtop Bio-Lab TFF for research and small-scale production and Bio-TFF skids for industrial scale.

Main features are:

• Hygienic design, compliant with GMP and ASME BPE requirements;
• Use sanitary grade peristaltic, quaternary diaphragm pump or rotor pump, low shear force, low pulse;
• Automatic TMP control, automatic concentration, equal volume filtration and other functions;
• Equipped with a built-in integrity detection module, without the need for an external integrity detector;
• English operating system, software complies with the requirements of FDA 21 CFR Part 11;
• Systems can be customized according to different technical requirements;
• Producer provides complete set of GMP verification documents and services

All the systems are customized and configured according to the customer’s needs and utilize the same software as non-disposable CIP/SIP down-stream equipment (complies with the requirements of FDA 21 CFR Part 11).

The pump heads, valves, probes (flow meters, pH, conductivity and UV detectors), tubing and other liquid contact components of single-use down-stream equipment are constructed as disposable replaceable parts, the “flow-path lines” are packaged aseptically in advance and installed directly after unpacking prior to use. 

Single-use design eliminates the needs of system cleaning between different batches and products and subsequent after-CIP validation; minimizes risk of cross-contamination; reduces facility area, production cycle time and cost; improves consistency and productivity for smaller scale facilities.

Hanbon provides FDA and USP VI certificates for non stainless steel materials in contact with the material liquid.

Newstyle laboratory liquid chromatography systems were developed for laboratory analysis, small-scale and pilot scale up. The infusion pump head and liquid circuit contact materials can be selected from SS316L, titanium alloy, PEEK etc., which are suitable for the special requirements of different customers’ processes. Dual wavelength UV visible detector, which can expand the detection range, and can also be equipped with differential refractive detector or evaporative luminescence detector.

CS-Prep industrial preparative HPLC systems include infusion, injection, detection, distillate collection, control and data processing modules. This model became the first diaphragm pump explosion-proof industrial preparation liquid chromatography system in China, which achieved balance, sample loading, flushing, elution, automatic collection, online cleaning and other process.

In 2005 Hanbon developed the first dynamic axial compression column with independent intellectual property rights in China, and by nowadays has built the largest dynamic axial compression column production and assembly workshop in the world. Dynamic axial compression columns are automated self-packed and unpacked in place devices, have pressure control system and can totally satisfy the continuity of the column bed, uniformity, stability, and tightness requirements, eliminate the influence of the column bed collapse.

Hanbon production facility is based on the design and implementation process of GAMP 5; producer provides complete GMP and FDA verification documents and services.

The control software is based on the secondary development of imported workstations and meets the requirements of FDA 21CFR Part 11.

Main features are:

• Imported Schott finished glass tube, easy to seal, high strength;
• Easy to Operate: The side sliding design of the column head eliminates the need for manual handling;
• Convenient Replacement: The sieve plate can be directly replaced at the bottom without disassembling the column barrel;
• Original Sealing Form: Original and highly reliable column head sealing form, manual sealing or automatic sealing; 
• Highly Capable: Reliable, convenient and safe operation
• Excellent Performance: The flow path has no dead zone design and excellent cleaning and verification performance; 
• Certified: The liquid receiving material is made of EU and US origin materials, totally complying with USP Class VI and FDA standards; 
• Documents & Services: Producer provides complete GMP verification documents and services.

All the devices come with verification documents that comply with GMP regulations.

Main features are:

• Key components of the system adopt internationally renowned brands, which are stable and reliable;
• The pipeline design adopts ASME BPE standard, with inner wall electric polishing, Ra ≤ 0.4um, and automatic welding;
• Provide FDA or USP Class VI material certification for non-stainless steel materials in contact with the sample;
• All stainless steel materials in contact with the sample have a serial number, serial number/furnace number to ensure traceability;
• The instrument adopts digital communication to overcome the problems caused by analog signals;
• HMI adopts self-developed software on the C # platform, which meets the requirements of FDA 21 CFR Part 11;
• Using a database to store data and having mature and reliable solutions to interface with various DCS systems;
• Provide complete GMP verification documents and services;
• Can achieve double-column position series-parallel connection.

All the models meet the GLP/GMP requirements, validation documentation (DQ/IQ/OQ) is providing with each system by default. Bio-Lab software conforms to GLP/GMP and FDA 21CFR Part11 requirements.

All the devices are configured according to the customer’s requirements basing on 4 main platforms: Bio-Lab 30 / 100 / 300 / 600.

reducing the risks caused by large differences between batches in the production process. ACC series of automatic chromatographic columns are suitable for most types of chromatographic resins and corresponding column loading methods in the biopharmaceutical industry, and meet the production requirements of diversified products.

Main features are:

• All the models are equipped with automatic column loading workstation, providing fully automatic column loading, unloading, cleaning, easy and convenient maintenance;
• Key components adopt international first-class brands;
• The upper and lower limits of the chromatographic column are protected by software, photoelectric sensors, and machinery to ensure the safety of equipment and personnel;
• Patented piston sealing design, better sealing performance;
• Patent piston exhaust structure design, convenient and fast exhaust;
• Hi-tech distributor structure design ensures uniform distribution of material and liquid;
• High precision servo motor drive, high operating accuracy;
• The hygiene grade design has no dead volume, and the liquid receiving materials comply with relevant pharmaceutical regulations such as USP VI or FDA;
• The column operation and control software meets the requirements of FDA 21 CFR Part 11 and meets the requirements for remote backup and storage of data.

Innovative Design for GMP Compliance

One of the key advantages of the CGX10 Cell Isolation System is its fully closed design, which is essential for maintaining GMP compliance during cell production processes. Traditional flow cytometers, which have been widely used in research laboratories and early-phase clinical studies, often fall short in GMP environments due to their complex design and the potential for inducing stress or damage to sorted cells. The CGX10 overcomes these limitations by providing a robust, closed system that minimizes the risk of contamination and ensures the highest cell viability during the sorting process. This makes it an ideal choice for environments where strict regulatory standards must be met.

Superior Cell Isolation with Multi-Marker Selection

The ability to isolate cells based on multiple biomarkers is a crucial feature of the CGX10 system. In cell and gene therapies, it is often necessary to identify and isolate specific immune cells that exhibit the desired phenotype, which may be defined by the presence of one or more biomarkers. Multi-marker-based cell isolation not only enhances the purity of the isolated cells but also allows for the selective elimination of non-target cells, such as over-differentiated T cells, which may be therapeutically ineffective. By ensuring that only the most relevant cells are selected, the CGX10 improves the overall efficacy of cell-based therapies.

In contrast to traditional flow cytometers, which are typically limited in their ability to handle complex multi-marker sorting in a GMP setting, the CGX10 is designed to excel in these environments. Its advanced technology allows for precise, high-purity isolation of target cells while maintaining their viability, making it a critical tool for researchers and manufacturers involved in the development of advanced therapy medicinal products (ATMPs), including cell and gene therapies.

Streamlined Operation for Efficient Cell Production

Ease of operation is another hallmark of the CGX10 Cell Isolation System. The system is designed to provide a seamless user experience, making it accessible to trained laboratory technicians who may not have specialized expertise in flow cytometry. This is particularly important in GMP-compliant environments, where the complexity and subjectivity of conventional sorter platforms can be a significant barrier to efficient cell production. The CGX10 simplifies the cell isolation process, reducing the need for extensive operator training and minimizing the potential for user error.

The system’s intuitive interface and automated processes allow for a smooth transition from process development to full-scale cell production. This flexibility is essential for laboratories and manufacturing facilities that are scaling up their operations to meet the growing demand for cell-based therapies. By streamlining the workflow, the CGX10 enables researchers and manufacturers to focus on the critical aspects of their work, such as optimizing cell culture conditions and ensuring the quality of the final product.

Application in Advanced Cell and Gene Therapies

The CGX10 Cell Isolation System is specifically designed for use in research, process development, and manufacturing environments related to advanced therapy medicinal products (ATMPs), including cell and gene therapies. These fields have seen significant progress in recent years, driven by the need to develop more effective treatments for a range of diseases. The ability to isolate specific cell populations with high precision is a key factor in the success of these therapies, and the CGX10 provides the tools needed to achieve this.

It is important to note that the CGX10 and its related products are intended for ex vivo cell separation processing only. They are not designed for therapeutic, diagnostic, or in vivo applications in humans. Any clinical use of the cells processed with the CGX10 must adhere to the relevant regulations, and it is the responsibility of the user to ensure compliance with these standards. The CGX10 system is not sold as a medical device, and its use in clinical applications is subject to the appropriate regulatory approvals.

Ensuring the Highest Standards of Cell Production

In the context of GMP-compliant cell production, the CGX10 Cell Isolation System offers unparalleled reliability and performance. Its closed design, multi-marker selection capabilities, and user-friendly operation make it an ideal choice for laboratories and manufacturing facilities that require precise, high-purity cell sorting. As the demand for cell and gene therapies continues to grow, the CGX10 provides the flexibility and efficiency needed to support the development of these innovative treatments.

Moreover, the system’s ability to maintain high cell viability throughout the sorting process is crucial for the success of cell-based therapies. By minimizing the potential for stress or damage to the sorted cells, the CGX10 ensures that the final product is of the highest quality, which is essential for both research and clinical applications. This makes the CGX10 an invaluable tool for advancing the field of regenerative medicine and for bringing new therapies to market.

Conclusion

The CGX10 Cell Isolation System represents a significant advancement in the field of cell sorting and isolation, particularly in the context of GMP-compliant environments. Its fully closed design, multi-marker selection capabilities, and streamlined operation set it apart from traditional flow cytometers, making it the ideal choice for laboratories and manufacturing facilities involved in the development of advanced cell and gene therapies. As the only fully closed system available for GMP-compliant cell production, the CGX10 offers the reliability, flexibility, and ease of use needed to support the growing demand for high-quality cell-based therapies.

In summary, the CGX10 Cell Isolation System is not just a tool for cell sorting; it is a comprehensive solution for researchers and manufacturers working at the forefront of regenerative medicine. With its ability to deliver high-purity, viable cells in a GMP-compliant environment, the CGX10 is poised to play a crucial role in the advancement of cell and gene therapies, ultimately improving patient outcomes and driving innovation in the field of medicine.