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Frequently Asked Questions

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Yes, the training courses will enable customers to acquire proper knowledge and skills to set up and operate the equipment. In addition, VacciXcell offers advanced courses that cover the topics such as preventive maintenance, inoculation/cell culture and sampling techniques, harvesting and primary product recovery. All bioreactors and fermenters are ready-to-use and delivered with complete FAT, installation, and SAT.
Yes, interested customers can contact our technical support team for further information.
We provide a continuous supply statement called "Material and Service Supply Guarantee". The content can be modified to meet all of your basic requirements.
You can reach us through email at [email protected] or call us by phone at +65 6542 0833. We recommend you to provide us information by filling up the form of Preliminary Questions for Potential Customer in order for us to properly assist you on the experiments and budgets you require.
Yes. We provide one year warranty for TideXcell system from the completion day of SAT against defects in material and workmanship. Consumables such as quick connectors, tubing, and cables are excluded. We also provide preventive maintenance for best performance during operation and process.
  • We are knowledgeable on cGMP cell culture, virus production and biologics production. Our staff have basic cell culture knowledge with proper training to support sales activities.
  • We provide quick and good after-service and maintain engagement with our clients.
  • We actively participate in exhibitions to demonstrate our products and find the new leads.
No
Cell attachment is dependent on the cell line. It may vary from a few minutes to a few hours
There is zero shear stress due to the gentle Tide Motion (only 2mm/s max). This means that there are almost no cell debris thus no blockage whatsoever.
Cells grow in 3D
This is determined by glucose consumption of the culture. Generally, glucose level starts at 4.5 g/ml and media change is required when the glucose level goes down to 1 g/ml. Media glucose requirement may change depending on many factors and having a glucose curve would help determine the most efficient time for media change.
Possible sources of contamination during cell culture include improper sealing to the matrix vessel or connectors, non-sterile components in contact with the culture medium, and inappropriate aseptic connection techniques. It is important that filling reagents or connecting tubes must be handled under sterile condition such as a laminar flow cabinet whenever possible.
If the setting of parameters for the bioreactor are out of the optimal range, the product yield of the cell culture may have been compromised. Over-fluctuation of pH or DO readings can be caused by the lack of nutrients, such as glucose, in the culture media and may result to poor yield of the product.
Once the cell growth reaches plateau, the product harvest of secretory protein may last for a few weeks. Our records shows 4 months without breaking the bellow of CelCradle.
Yes, the serum-free medium is compatible for cell culture in both CelCradle and TideXcell system. In an effort to eliminate potential risks associated with the introduction of adventitious agents from animal-derived components, VacciXcell also provides a medium supplement, Super Plus, to replace the use of serum in the medium.
It is necessary to replace the old medium three days after cell seeding; this is to ensure the attachment and propagation of cells. The appearance and turbidity of the medium can be inspected with the naked eye, while the pH can be measured when changing the medium. However, if you prefer not to change the medium, just add NaHCO3 to adjust the pH (till orange red).
This highly depends on the customer experimental settings, such as the CO2 introduction, the components of the medium, the number of cells during cell seeding, the metabolic activity of the cells, growth factors' activity, and total working volume of your culture medium in CelCradle/TideXcell bioreactors. A rough visual indicator could be the change in the color of the culture medium (if phenol red is included) due to pH change, while a more accurate indicator is the measurement of glucose levels. The medium can be changed when the glucose level drops below the desired threshold.
Yes, you can. The purpose of triplicate measurement is to increase the precision of monitoring and controlling the process. The frequency of measurement can be decreased after the process has stabilized.
Virus aggregation has not been reported in TideXcell or CelCradle® system. The system functions by exposing and submerging the carriers periodically, in which the mechanism is similar with the roller bottles. The major difference is that the cell growth is in 3D pattern. However, higher virus concentration during down-stream purification process may cause virus aggregation and users can add emulsifying agents (Tween20 or Tween80) to alleviate the aggregation problems.
  • The probe must be washed thoroughly with appropriate cleaning agents before and after use.
  • Do not leave the end of the probe dry and keep it submerged in the electrolyte (e.g. 3 M KCl) when not in use to extend the lifespan. The electrolyte should be changed regularly.
  • Be careful not to introduce any bubbles to the electrode as this will make unstable measurements.
  • The pH probe can usually tolerate 20 - 50 autoclave cycles.
  • The probe must be washed thoroughly with appropriate cleaning agents (e.g. ddH2O). Do not use alcohol as this can damage the sensor or lead to erroneous current.
  • The membrane foil should be cleaned and properly installed prior to calibration.
  • If you find fluctuation in the readings, inability to do calibration, or low DO probe current, the membrane body might need to be replaced.
  • For short term storage, keep the sensor submerged in O2 electrolyte. For long term storage (at least 6 months), the probe should be stored dry.
It will take approximately 10 days, when seeding 1x108 Vero cells in one CelCradle bottle (100 ml matrix), to reach maximum cell density (4x109). On the other hand, it will take approximately 6 days, when seeding 1.5x1011 cells in TideXcell-100 (100 L matrix), to reach the maximum cell density.
CPE can be observed the same way as how you observe cells by fixing the carriers with alcohol and staining them with dyes. Different viruses will have different CPE with different cells. Some viruses will cause clear CPE, and some will not. For instance, rabies virus was observed under fluorescence microscopy and no CPE was detected; on the other hand, Sf-9 insect cells infected with baculoviruses were observed to have shrunken cells, while H5N1 influenza virus causes cell death and shape irregularity in MDCK cells.

For virus production process, we usually decide the end point by checking the glucose consumption rate, since CPE provides a rough evidence, while the glucose consumption rate is a more accurate determinant of harvesting time. Moreover, the end-point also depends on the stability of the virus during post-infection period.
You can use a virus counter to determine the free total virus particles before and after infection. Alternatively, if you are not required to monitor real-time change, you can perform a validation study by measuring the virus titer against time after infection. You can analyze the medium using conventional method with intervals of 10 min., 30 min., 60 min., 2 hours, etc.
CO2 concentration is adjusted dynamically according to the pH during cell culture. If cells continue to grow or multiply after the infection of virus, CO2 requirement will be minimized. However, if the cells die, there will be an increase in pH and CO2 requirement will increase as well.
  • Healthy cells
  • Infectious active virus
  • Post-Infection temperature
  • Multiplicity of Infection (MOI)
  • Harvest strategy
All commonly-used adherent cells have been grown on the CelCradle® bioreactor including VERO, HEK 293, CHO, and MDCK cells.

The mechanism of CelCradle® enables fast and complete diffusion of nutrients and oxygen in the medium to the matrix. All ingredients in the medium are properly mixed while the CO2 produced by glucose hydrolysis can be expelled efficiently along the run. The CelCradle® system also has a high productivity – 1 CelCradle® bottle is equivalent to 20 x 850cm2 roller bottles, 4 x 500ml Spinner Flask, 100 x 180cm2 petri dishes, 2 x 6320cm2 plates or 125 x 150cm2 T-flasks. It also provides cells with an environment of low shear stress, zero foaming and bubbling, and no oxygen limitation.

CelCradle® are well patented and the patent covers US, Europe, Japan, China and Taiwan.
There are regularly 865 pieces of BioNOC II® in each CelCradle bottle. The deviation is less than 5%.
There are several ways to solve the issue:
  1. To use enzyme other than trypsin, for example, Accutase. Some other enzyme but not trypsin-based may also be helpful.
  2. To disrupt the cells from the carriers through freeze-and-thaw, with lysis buffer, or other methods.
Two pieces of carriers are required for every cell counting procedure. However, it is suggested to perform the test thrice and then stain with CVD and then multiply averaged calculated cell number by 865 (piece/ CelCradle bottle). The result would be the total cell numbers. Before trypsinization, check the reference to make sure that cells can be detached. It is usually more difficult to detach bigger cells.
Without changing the gene of cells, it is very unlikely to promote the cell propagation while limiting critical nutrients. With the same quantity of medium in a certain period of time, CelCradle’s maximum output may not be different from those of other commercial products. However, CelCradle does present higher cell density due to the cell growth pattern.
The output of one CelCradle® bottle is approximately 5 × 109 cells/bottle, which will vary depending on the cell type. Cell harvest is easy, you can follow the provided SOP and achieve more than 90% recovery.
CelCradle only works for adherent cell culture. However, if the specific suspension cells could attach in the CelCradle system, the secreted protein can be harvested for long periods with much lower cost than commercial suspension culture system.
Yes. CelCradle-500A or CelCradle-500AP is suitable for production of both secreted and non-secreted products. Since these two types of bottles are specifically designed to enhance the cell attachment efficiency, we suggest to use them with the up-side-down seeding protocol if your cell line has difficulties to adhere the carriers.
The main console of the CelCradle Stage meets IP54.

CelCradle-500 is used mostly in the lab for research and tissue engineering whereas TideXcell-002 can be applied in both academy and small pilot tests. The final cell densities in both systems are quite related proportionally. However, the productivity and cell growth rate depend on several factors.

Since CelCradle-500 doesn’t have pH control and perfusion culture mode, the cell growth usually is slower than in TideXcell-002, under a manual operation. With respect to the linearity of scale-up, TideXcell-002 is better than CelCradle-500. The parameter setting in CelCradle-500 could be used in TideXcell-002, but some modifications are still necessary. Compared with other commercially-available systems, however, very few parameters are required to input in the TideXcell system. Therefore optimization is quite straight -forward.

The surface of the BioNOC II® carriers in the CelCradle is negative charged and should be OK for the coating of Matrigel if it could be coated on petri dish or T-flask (those are all negative charge surface). Some sources of HEK293, for example, are difficult to attach, and therefore we would make coating or use CelCradle-500A to enhance the cell attachment efficiency.
VACCIXCELL Bioengineering is an ISO 9001:2008 certificated company. The quality documents for CelCradle include the Certificate of Qualification (CoQ) and Certificate of Compliance (CoC). The CelCradle Stage includes the CE certificate and Certificate of Qualification (CoQ). Can the standard CelCradle bottle be frozen?
Yes. The bottle could be placed in -80 °C freezer directly for free-and-thaw process to extract cellular components.
Once the nutrients of medium are consumed, you need to refresh culture medium. To maintain 10 days without exchanging culture medium, under high cell density, is very difficult unless the culture temperature can be reduced to below 10 C. Or supplement such as glucose and glutamine concentrate should be added to maintain the cell viability. Be sure to control pH within the proper range (7.0~7.4) by adding concentrated NaHCO3. However, the osmolarity will increase and affect cell viability if too much sodium bicarbonate is added.
Cell growth test must be performed and the cell density must be monitored every other day until the cell growth reaches a plateau (no further growth of cells). The maximum cell density will vary depending on the cell line.
It depends on how the viruses infect cells. If the viruses could effectively infect the cells, he could do infection as the regular way as cell seeding.
Usually 100~120 ml is sufficient.
Yes. For the cell harvest, it is better to use CelCradle-500A since it requires less trypsin to detach cells, less wash buffer, and has higher cell recovery rate.

CelCradle-500 is used mostly in the lab for research and tissue engineering whereas TideXcell-002 can be applied in both academy and small pilot tests. The final cell densities in both systems are quite related proportionally. However, the productivity and cell growth rate depend on several factors.

Since CelCradle-500 doesn’t have pH control and perfusion culture mode, the cell growth usualy is slower than in TideXcell-002, under a manual operation. With respect to the linearity of scale-up, TideXcell-002 is better than CelCradle-500. The parameter setting in CelCradle-500 could be used in commercially-available systems, however, very few parameters are required to input in the TideXcell System. Therefore optimization is quite straight-forward.

Yes, the bottles are pre-sterilized using gamma irradiation process
As long as the desired protein is produced by adherent cell it can be grown in CelCradle
Yes. Mechanical agitation through rotating or shaking the bottle is required. Alternatively, clients can try the automated harvesting system for CelCradle for USD 5,000.
CelCradle is a high yield tide motion cell culture device for the production of cells, proteins, monoclonal antibodies, viruses, and/or vaccine. CelCradle provides high aeration rate under the culture environment, allowing a high cell density culture to be achieved easily.

CelCradle is composed of CelCradle Stage, Controller, CelFeeder pump –depends on the application- and CelCradle Bottle.

CelCradle bottle is composed of 4 parts: Vented bottle Lid, Culture Container, BioNOC II® (Carrier) Container, Media Container. Depends on Bottle type, some also comprise (500A and 500AP bottles) non-vented bottle lid.

CelCradle bottle is ready to use bottle, designed for one time use only, and cannot be autoclaved. Reusing CelCradle bottle is not recommended.
Users need a CelCradle Stage-CelCradle controller and 6-cube ft. CO2 incubator. No tubing or pumps are required for batch system (CelCradle-500 or CelCradle-500A). Additional pump system, namely CelFeeder-1300 and tubing set will need to operate CelCradle-500P or CelCradle-500AP bottles.
We are using PTFE hydrophobic filter with 0.22um pore size.
CelCradle has 3 materials. Bottle parts is made of PET, Bellow part is made of EVA and Other blue parts are made of PP.
Yes. Most serum-free medium can be applied in CelCradle-500 system.

If CelCradle-500/500A is used, then just to replace culture medium manually by opening the cap inside biosafety cabinet and discard the used culture medium and then fill in fresh culture medium.

If CelCradle-500P/500AP is used, then need to replenish the culture medium in the reservoir depends on how quick the glucose is consumed.

The surface of the BioNOC II® carriers in the CelCradle is negative charged and should be OK for the coating of Matrigel if it could be coated on petri dish or T-flask (those are all negative charge surface). Some sources of HEK293, for example, are difficult to attach, and therefore we would make coating or use CelCradle-500A to enhance the cell attachment efficiency.
Users have to sample the BioNOC II® carriers inside the CelCradle before observing the cells. The disks are made of porous nonwoven fabrics. The common staining solution is hematoxylin, coomassie brilliant blue G, ... etc.

Yes. CelCradle-500/500P equips a sampling port on the carrier basket. With sterilized forceps, users take out carriers during culture.

CelCradle-500A/500AP doesn’t have carrier basket, so with sterilized forceps, users can take out carriers, or harvest carriers.

There are two methods for users to observe the culture performance.

Way 1 : to measure the metabolite consumption in the cultured media. The pH and glucose are the bassic parameters to be monitored during culture.

Way 2 : to count cells. You can pick up carriers during culture, and count the cells by using dye.

CelCradle-500 and CelCradle-500P are not possible to harvest the cells. Only CelCradle-500A and CelCradle-500AP are available.

There are two ways to solve the issue:

Way 1 : To use enzyme other than trypsin, for example, Accutase. Some other enzyme but not trypsin-based may also be helpful.

Way 2 : To disrupt the cells from the carriers through freeze-and-thaw, with lysis buffer, or other methods.

Usually we put 450 – 470ml fresh culture medium in CelCradle first and prepare cells in 50ml centrifuge tube after collection. Then we dispense cells with 30 – 50ml into the CelCradle bottle.
Yes, the bottles are pre-sterilized using gamma irradiation process
As long as the desired protein is produced by adherent cell it can be grown in CelCradle
Yes. Mechanical agitation through rotating or shaking the bottle is required. Alternatively, clients can try the automated harvesting system for CelCradle for USD 5,000.
CelCradle is a high yield tide motion cell culture device for the production of cells, proteins, monoclonal antibodies, viruses, and/or vaccine. CelCradle provides high aeration rate under the culture environment, allowing a high cell density culture to be achieved easily.

CelCradle is composed of CelCradle Stage, Controller, CelFeeder pump –depends on the application- and CelCradle Bottle.

CelCradle bottle is composed of 4 parts: Vented bottle Lid, Culture Container, BioNOC II® (Carrier) Container, Media Container. Depends on Bottle type, some also comprise (500A and 500AP bottles) non-vented bottle lid.

CelCradle bottle is ready to use bottle, designed for one time use only, and cannot be autoclaved. Reusing CelCradle bottle is not recommended.
Users need a CelCradle Stage-CelCradle controller and 6-cube ft. CO2 incubator. No tubing or pumps are required for batch system (CelCradle-500 or CelCradle-500A). Additional pump system, namely CelFeeder-1300 and tubing set will need to operate CelCradle-500P or CelCradle-500AP bottles.
We are using PTFE hydrophobic filter with 0.22um pore size.
CelCradle has 3 materials. Bottle parts is made of PET, Bellow part is made of EVA and Other blue parts are made of PP.
Yes. Most serum-free medium can be applied in CelCradle-500 system.

If CelCradle-500/500A is used, then just to replace culture medium manually by opening the cap inside biosafety cabinet and discard the used culture medium and then fill in fresh culture medium.

If CelCradle-500P/500AP is used, then need to replenish the culture medium in the reservoir depends on how quick the glucose is consumed.

The surface of the BioNOC II® carriers in the CelCradle is negative charged and should be OK for the coating of Matrigel if it could be coated on petri dish or T-flask (those are all negative charge surface). Some sources of HEK293, for example, are difficult to attach, and therefore we would make coating or use CelCradle-500A to enhance the cell attachment efficiency.
Users have to sample the BioNOC II® carriers inside the CelCradle before observing the cells. The disks are made of porous nonwoven fabrics. The common staining solution is hematoxylin, coomassie brilliant blue G, ... etc.

Yes. CelCradle-500/500P equips a sampling port on the carrier basket. With sterilized forceps, users take out carriers during culture.

CelCradle-500A/500AP doesn’t have carrier basket, so with sterilized forceps, users can take out carriers, or harvest carriers.

There are two methods for users to observe the culture performance.

Way 1 : to measure the metabolite consumption in the cultured media. The pH and glucose are the bassic parameters to be monitored during culture.

Way 2 : to count cells. You can pick up carriers during culture, and count the cells by using dye.

CelCradle-500 and CelCradle-500P are not possible to harvest the cells. Only CelCradle-500A and CelCradle-500AP are available.

There are two ways to solve the issue:

Way 1 : To use enzyme other than trypsin, for example, Accutase. Some other enzyme but not trypsin-based may also be helpful.

Way 2 : To disrupt the cells from the carriers through freeze-and-thaw, with lysis buffer, or other methods.

Usually we put 450 – 470ml fresh culture medium in CelCradle first and prepare cells in 50ml centrifuge tube after collection. Then we dispense cells with 30 – 50ml into the CelCradle bottle.
No, the hybrid bioreactor contains PLC-based control structure and a touch screen HMI which makes it easier to use and understand.
ModelVol. of BioNOC II®Matrix volumeEquivalence to Stirred Tank Bioreactors
1:10
Mixing Ratio		1:20
Mixing Ratio
TideXcell-002110g2000 ml20L40L
TideXcell-010550g10,000 ml100L200L
TideXcell-0201100g20,000 ml200L400L
TideXcell-1005500g100,000 ml1000L2000L
ModelCell Seeding

(Recommended)		Expected Resulting Cell Density
TideXcell-0022x109 cells2x1010 cells
TideXcell-0101x1010 cells1x1011 cells
TideXcell-0202x1010 cells2x1011 cells
TideXcell-1001x1011 cells1x1012 cells
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.
TideXcell 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 TideXcell 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 TideXcell® system controls the up and down speed of the medium in the matrix vessel, duration of aeration and nutrition, temperature, level, duration of each FEED/HARVEST cycle, pH, DO, CO2 concentration in the incubation chamber, valves for each gas, peristaltic pump speed, gas flow, and etc.
All TideXcell® systems are equipped with TideCommander and TideTracer. These user-friendly software offer a convenient way for parameter settings, profile check, and various feed/harvest strategies without any need of programming.
TideXcell 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 TideXcell could support most oxygen from the matrix side.
TideXcell® system controls the pH either by introducing CO2 to the matrix vessel in the culture chamber or by loading NaOH or HCl solution to the medium mixing vessel (bag). NaHCO3 can be used as an alternative for NaOH, this will not become a problem in perfusion culture since the osmolarity will not accumulate.
The data from pH and DO can be collected and saved automatically and are traceable. They can be retrieved depending on the time (Year-Month-Day-Minute-Second) but cannot be modified, in accordance to regulation standards. RS485 communication protocol/pin-out definition can be provided. Real-time data can be printed on paper with the use of RS485 interface.
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 TideXcell system has a different range of flow rate setting: TideXcell-002: 0.8~1.8 L/min; TideXcell-010: 1.8~3.5 L/min; TideXcell-020: 3.5~5.0 L/min; TideXcell-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 BioNOC II® matrices.
The purpose for sampling cells is to have an overall image about the cell viability and density daily. In the TideXcell matrix vessel, the sampling port with the matrix basket allows the user to get pieces of BioNOC II® matrices for cell observation and quantification. The glucose consumption rate is another index to judge the cell growth.
The external surfaces of the TideXcell® System is made of SS304L, while the internal surfaces are made of SS316L.

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 TideXcell systems on the customer site. It is part of URS.

The validation of TideXcell 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.

Yes, Esco VacciXcell offers Stainless Steel SIP stirred tank bioreactors and fermenters and Stainless Steel SIP solid state fermenters. Should the client require it, VacciXcell can also provide stainless steel SIP mixing systems for the TideXcell® System.
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 aeration during emerging and to nutrition during submerging and therefore vertically, cells may have different aeration and nutrition times. However, our findings show no disadvantage as long as the system can provide cells with sufficient oxygen and nutrient.

The real situation is that the cells are embedded inside the carriers and there is always a layer of culture medium absorbed the carriers. Therefore, whether the system is in aeration or nutrition phase, the cells are technically always 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 the cells. The tide movement is to maintain the supply of oxygen and nutrients and to remove waste, a very similar concept to roller bottles.

Most of our customers choose roller bottles as the seeding source. In addition to CelCradle® System and smaller scale of TideXcell system, the customer can use any other bioreactors for seed preparation such as Cell Factory or microcarrier systems. Two CelCradle® bottles can be used for the seed preparation for TideXcell-002 and ten CelCradle® bottles can be used to seed TideXcell-010. VacciXcell also provides automatic Cell Harvest System to harvest cells from TideXcell matrix vessel.

The commercial microcarrier system is a very difficult process. Though it is relatively easy in the small scale, scaling up to production scale is difficult and complex. The microcarrier system also incurs shear stress, foaming, and bubbling, which may all lead to cell death. Cell death not only decreases productivity but also increases downstream processing costs, due to increased cell debris.

VacciXcell’s tide motion system is simple and applies a similar principle as that of the roller bottles. Most of our customers use roller bottles and transfer to our technology directly without any problems. Those that tried to use the microcarrier system failed and eventually switched to the tide motion system.

Inoculation

  • Clamp the tube between Matrix Vessel and Mixing Vessel.
  • Prepare at least 3x109 cells in pre-warmed 800 ml culture medium per L matrices.
  • Disconnect the air tube inside TideXcell Culture Chamber with the Matrix Vessel. Move the Matrix Vessel to Biosafety cabinet.
  • Load the cells into the Matrix Vessel.  Mix the cell containing culture medium together with the Matrixes by gently shaking the matrix vessel in a rotational manner by hand for 3 minutes.
  • Place the Matrix Vessel back to the Culture Chamber. Reconnect the air tube with the Matrix Vessel.
  • Remove the clamp on the tube between the Matrix Vessel and Mixing Vessel.
Currently, we only have closed sampling for single use system but we are developing a sampling mechanism for multiple use system. There is no need to open the matrix vessel during sampling. If you can imagine a “crane game” in arcades, the concept is similar to that one.

For contamination issues, it highly depends on how the customer controls the culture environment and operation. Customers seldom report contamination issues to us which we think is due to the fact that most contamination issues are due to their process and practices and is rarely due to the equipment itself. Using our single-use system would make contamination risk almost 0.

In terms of component failure, we have had some cases but it is quite rare, roughly 1% and all these cases are after warranty periods. Strictly following the maintenance schedule is very important to minimize or reduce the risk of system failure. 

BioNOC II® matrix is made of 100% non-woven polyethylene terephthalate (PET) . It is resistant to chemicals and autoclavable.
BioNOC II® is applicable to anchorage-dependent cells, and we have widespread, successful experiences on the cell culture.
The shelf life is four years without decay of hydrophilicity.
There is approximately 2400 CM2 of effective surface area. There are 5.5 g of BioNOC II® per 100 ml of bed volume.
  • CHO: CHO-S-SFM II (Gibco), CHO III A (Gibco), CHO-A-SFM (Gibco) , ExCELL 301 (JRH), HyQ PF-CHO (HyClone), HyQ-CCM 5 (HyClone), HyQ SFX-CHO (HyClone), IS-CHO-CD (IRVINE), proCHO4cdm
  • HEK-293: EX-CELL 293 (JRH), Pro293a-CDM (CAMBREX), HyQ SFM4 HEK293 (HyClone)
  • VERO: VP-SFM (Gibco), Plus VERO (VACCIXCELL), ICN-VERO (ICN), PEEK-1 (Biochrom),
  • Sf-9: SF-900 II (Gibco), EX-CELL 420 (JRH), EX-CELL 400
The essence of a low bioburden in BioNOC II® is that it does not encourage the growth of microorganism on the surface of the carriers, which may be a source of contamination.BioNOC II® also has low lint content making it ideal for 3D cell culture.
25uL
Phase-contrast inverted microscope with a good depth of field function is recommended
Yes. All products shipped to the customers are sterilized by gamma irradiation. An irradiation certificate is provided with the product.
The thickness depends on the material and purpose of the mixing bag. All bags are qualified in accordance with cGMP, USP Class VI Plastics, ASTM, and ISO.
Yes, you can. The medium bag is manufactured from US with ISO 13485;2003 certification and FDA registration, which has accepted a host of OEM from leaders of the medium bag in the market for years. Besides the comprehensive product line and validation documentation, we are confident to provide customization of bag products including film, tubing, connection, and filters, etc., to meet your specific needs and lean budget.
For cGMP grade, the minimum quantity is 25 kg. For the lab grade, the minimum order is 1 kg.
The purpose of SuperPlus is to reduce the use of serum in order to eliminate lot-to-lot variation and cost.
No. The meter and strips are not for medical or diagnostic use, and are only for lab and bioprocess application.

GlucCell Glucose Monitoring System is designed specifically for animal cell culture in which the embedded calibration curves are made. Currently we don’t have sufficient data showing that it could be used for microorganism culture with these existing calibration curves. However, following steps can be done to validate your application:

  1. Perform calibration with your existed culture medium with known glucose concentration by spiking known amount of glucose. If the initial glucose concentration of the medium is not adjustable, you have to prepare the medium by yourself by adding the component one by one and making several groups with different glucose concentration that could cover your test range.
  2. Spin-down the culture medium to remove the solid and measure the glucose only from the supernatant.
By the enzyme reaction, GlucCell only measures specifically glucose but not other sugars such as fructose or sucrose.
The reading E53 means that the detected glucose concentration is below the detectable range (20 mg/dL).
Generally, "glucose meter" is usually used by diabetic patients to monitor their blood sugar concentration. Therefore, it is difficult to obtain accurate data from cell culture medium by using this kind meter. On the contrary, GlucCell® glucose meter is specifically designed to measure glucose concentration in cell culture medium. The accuracy is not affected by the type of media, whether with serum or serum-free, with cell or cell-free. GlucCell® glucose meter is a palm size meter for glucose measurement particularly for animal cell culture.
The meter is designed to be calibration-free with our special technology to save customers’ time and money. However, especially in cGMP environment, customers have to do validation at the beginning to ensure the validity of the system. We encourage customers to do the validation by themselves and using the standard solution that they trust.
The system has been pre-calibrated and generates a CODE along with the Test Strips (The CODE is used as the calibration curve). Whenever users change to a new test strip batch/lot that has a code different from the code in your meter, the CODE needs to be reset to match the calibration curve.
Customer can do validation by measuring the glucose from standard glucose solution and confirm the accuracy matches their specifications. VacciXcell does not provide standard glucose solution but but we can provide a protocol on how to prepare a standard glucose solution.
No, the measurement will be invalid. If the meter’s CODE is different from the test strips’ CODE, it means that the system will use the wrong calibration curve thus resulting in a wrong result.
GlucCell® can only measure glucose and will not be able to measure other types of sugar

The CelCradle X® and TideXcell® systems are cGMP compliant. CelCradle, CelCradle X, CCX-SAH, CelShaker, CelXrocker, MinTide, TideXcell, TXLHS, and VXL Hybrid are ALL FDA-Listed products. 

cGMP (FDA cGMP standard): CelCradle® can comply to cGMP but it relies on the clinical sponsor or the appointed CMO through manual recording as part of their Process Qualification (PQ) and quality management release. The CMO or the clinical sponsor defines their own lot release for e.g. Esco Aster have a long list of quality control and quality assurance test, including cell-based assays and downstream purification methods to purify the product from our bioreactors. Used materials in all steps are fully traceable and uses serum/xeno-free chemically defined GMP media and cryopreservation.

See link: http://www.escoaster.com/white-paper-and-protocols/optimizing-large-scale-expansion-of-mesenchymal-stem-cells-in-3D-tide-motion-bioreactors/#content

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=618434&lpcd=KJF
GMP compliance: In terms of computer software, TideXcell® and CelCradle® X uses Siemens HMI/PLC that is FDA 21 CFR part 11 Compliant. CelCradle relies on external CO2 incubator where it may not be cGMP/GMP. See information below for further elaboration.

CelCradle® can be GMP-compliant if it is applied under cGMP (FDA cGMP standard) provided that they use a cGMP CO2 incubator that is connected to a Scada or Dcs system with eBatch records and eSignature.

If you are not using a cGMP incubator, manual logging is needed as part of Quality Management system and SOP or protocol. They should manually record in their production records what was adjusted in the incubator or cell manipulation, which person and at which time. This should also indicate which supervisor verified and who did the process QC to manually sample the BioNOC II during culture.


Disclaimer: cGMP/GMP (Iso 13485) may differ depending on your local authority who is final regulatory body, these suggestions from Esco as equipment manufacturer should not be mis used or mis represented. Your country local authority has final say in all cGMP/GMP matters.

Yes, the unit is controlled via Siemens HMI & PLC based monitoring and control system with simple, intuitive touchscreen. 21 cfr part 11 compliance, GAMP 5. VacciXcell Platform runs on WonderWare SCADA by default.
Note: 

Dual redundant systems for critical components such as PLC and pumps are catered at optional costs.
The PLC-based monitoring and control system can be connected and configured to SCADA systems that have DeltaV and Pcs7 controls
Esco Lifesciences Group
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