TideCell-002 -- 2L: 110 g; equivalent to 10~20 L commercial bioreactor.

TideCell-010 -- 10 L: 550 g; equivalent to 50~100 L commercial bioreactor

TideCell-020 -- 20 L: 1100 g; equivalent to 100~500 L commercial bioreactor

TideCell-100 -- 100 L: 5500 g; equivalent to 500~1000 L commercial bioreactor

We don’t have 50 L system but could put 50 L carriers in the 100 L system.  The surface of each system is around: 2L: 31.2 m²; 10L: 156 m²; 20L: 312 m²; 100L: 1560 m², respectively.

The input quantity is 1×10⁹/ml~2 ×10⁹ /ml cell. The final cell density will be around 1×10¹¹/ml cell.

This actually depends on the process. For rabies vaccine production, the proper volume ratio of matrix vessel to medium tank is 1:10.

It should be 220 V, 50/60 Hz, single phase. The UPS is highly recommended.

TideCell system requires only electricity and compressed air. Three kinds of gases could be introduced in the system– air, CO₂, and O₂. For the area that electricity blackout occurs frequently, UPS is highly recommended.

All TideCell systems can be equipped with on-line UPS (option) to avoid external interruption to the power supply.

Yes, the button of Emergency Stop is on accessible area and independent for each major unit.

The TideCell system controls duration of each FEED/HARVEST cycle, level/temperature of process mass inside the chamber, pH/DO, CO₂ concentration in the incubation chamber, valves for each gas, peristaltic pump speed, gas flow, and etc.

All TideCell systems are equipped with the software TideCommander and TideTracer. The software offers an easy way to implement parameter settings, profile check, and various feed/harvest strategies without any need of programming.

TideCell can only monitor the value of DO. We can supply pure oxygen from the mixing tank and from the data, the DO could rise to 80% with small amount of oxygen supply. That means the TideCell could support most oxygen from the matrix side.

TideCell system controls pH by using introducing CO₂ at the matrix vessel in the culture chamber and input NaOH / HCl solution at the medium mixing vessel (bag). Using NaHCO₃ instead of NaOH should not be a problem for perfusion culture since the osmolarity won’t be accumulated. 

The data from pH and DO can be collected and saved automatically and traceable, which can be retrieved according to the time (Year-Month-Day-Minute-Second) but cannot be modified in order to meet the regulation requirement.

If necessary, we provide RS485 communication protocol/pin-out definition. With user’s recorder with RS485 interface, the real-time data can be exported on the paper.

For Vero cell in TideCell, the total amount is 4x10¹² in TideCell 100L matrix vessel. The output should be very similar to that of commercial microcarrier systems.

Each cartridge will contain 41 g of BioNOCII and there are 122 cartridges in 115 L matrix vessel. 

A floor load with 500 kg/m² is enough.

By air pressure. An air pump in the controller pump in and out of the air from the matrix vessel. When pumping filtered air into the matrix vessel, the medium will drain out to the external medium tank (bag); when pumping air out of the matrix vessel, the medium will fill(refill) in to the matrix vessel.

Each scale of TideCell system has a different range of flow rate setting: TideCell-002: 0.8~1.8 L/min; TideCell-010: 1.8~3.5 L/min; TideCell-020: 3.5~5.0 L/min; TideCell-100: 20~30 L/min. At the initial stage of the cell culture, you need to apply somewhat lower flow rate in order to seed the cells on the BioNOCII matrices.

The purpose for sampling cells is to have an overall image about the cell viability and density daily. In the TideCell matrix vessel, the sampling port with the matrix basket allows the user to get pieces of BioNOCII matrices for cell observation and quantification. The glucose consumption rate is another index to judge the cell growth.

All metallic non-product contact surfaces are constructed of SS304 grade or better with external surface finish, whereas the material selection of product contact surface will follow 21 CFR 211.65.

Yes, besides the function of “Emergency Stop”, event and alarming messages provide operators real-time monitoring of process variables and historical data. All deviations and user control actions (e.g. log-in/off, door open) are listed in the record.

An optional alarming notification is through the SCADA system or mobile communication such as cell phones via e-mail.

Yes. We can provide special monitor mount and keyboard/mouse, which are ergonomic, for the customer. 

It is prerequisite for us to propose the layout as well as the 3D location and orientation of TideCell systems on the customer site. It is part of URS.

The validation of TideCell system includes four major phases: DQ, IQ, OQ, and MQ. The validation may involve in inspection, functional testing, and documentation review, verifying that the system can run appropriately at the customer site.

DQ, Design Qualification, defines the functional and operational specification of an instrument or system

IQ, Installation Qualification, is the pre-installation detail that an instrument or system, its component parts and location, are fit for the purpose and satisfy the objectives or the user to carry out the intended function to expected standards.

OQ is Operation Qualification, demonstrating that an instrument or system will function according to its operational specification in the selected environment.

MQ is Maintenance Qualification, describing any maintenance required. 

No, these types of bioreactors may have several drawbacks including cleaning validation issues, higher risk of cross-contamination, and complexity of pipe work, lengthy turnaround time, and facility size.

The operator will define the feeding rate, and the autofeeder will pump in (the fresh medium) and pump out (the waste medium) automatically. For example, when we set the feeding rate is 2 L/hr, and 24 cycles/day (pump in and pump out 24 times a day, or once per hour), the autofeeder will pump out 2 L of waste medium first from the bioreactor to the waste line (or Harvest tank), and then pump in 2 L of fresh culture medium from the Feed tank to the bioreactor. The overall culture medium inside the bioreactor always keeps the same.

Cells are exposed to the gaseous phase during emerging and to the liquid phase during submerging therefore on each vertical position, cell may have different exposure time and submerge time, however, we didn’t find any disadvantage as long as this could provide the cells sufficient oxygen and nutrient.

The real situation is that the cells are embedded inside /between the carriers, and there is always a layer of culture medium surrounding the carriers. No matter during exposure phase or submerging phase, all cells are in the liquid phase. The quantity of culture medium remaining on the carriers is 20% of the entire bed volume, which is sufficient to supply the nutrient to cells. The Tide movement is to keep supplying oxygen, nutrient and removing waste, in which the mechanism is very similar to the roller bottle. 

Most of our customers choose roller bottles as the seeding source. In addition to BelloCell and smaller scale of TideCell system, the customer could run any other bioreactors for seed preparation such as Cell Factory or microcarrier systems. Two BelloCell bottles work for the seed for TideCell-002 and ten BelloCell bottles work for the seed for TideCell-010. We also provide automatic Cell Harvest System to harvest cells from TideCell matrix vessel. 

The commercial microcarrier system is a very difficult process. Though it is relatively easy in the small scale, it turns to be hard and complex to scale up in larger scale (production scale). Beads tend to attach on the bag film during rocking and cells thus are easily damaged. Our bioreactor system is a simple one and applied with similar principle of the roller bottles. Most of our customers use roller bottles and transfer using our technologies directly without any problems, while some customers tended to use microcarrier systems but got failed and finally consider our proposals.