| Wave BioreactorGENERAL QUESTIONS |
| Question |
Solution
|
| How does the Wave Bioreactor compare to conventional stirred tank bioreactors? |
Many
studies have shown that the performance of the
Wave Bioreactor exceeds, or equals that of a comparable
stirred tank bioreactor. Capital cost is about
30% of a stirred tank and procurement / commissioning
time can be reduced from 6 to 10 months for a
stirred tank installation to a few days. Utility
requirements are minimal. Saving in cleaning time
and turnaround results in an overall operating
cost about 1/3 that of a stirred tank. |
| When was the Wave Bioreactor developed? |
Development was started
in 1995 and the first commercial units were sold in 1998. Basic
patents were granted in 2000 and 2001. Hundreds of units are now
in operation all over the world. Read "The Wave Bioreactor Story" for the full story. |
| I am not sure that the Wave Bioreactor will work for my application. How can I test it? |
Call us. Our cell culture experts will
help you decide. We can put you in touch with existing users with
similar applications. We provide on-site training and even a money-back
performance guarantee. |
| Does air diffuse through the plastic culture bag? |
No. The plastic is gas-tight.
Air is introduced through an inlet filter, purged through the headspace,
and then exhausted out the outlet filter. Surface turbulence caused
by rocking ensures oxygen transfer to the liquid phase. |
| How well does the Wave Bioreactor scale-up? |
Scale-up in the Wave Bioreactor
is well-proven with many cell lines and virus systems. Units up
to 580 liter culture have been operated successfully. The unique
aeration system of the Wave Bioreactor actually improves on scale-up
and in most cases, the only parameter that changes on scale-up is
a small reduction in rocking rate and rock angle. |
| Can I use the Wave Bioreactor for GMP and human therapeutic production? |
Certainly. All culture
contact components meet USP Class VI standards. All Cellbags are
lot tested for endotoxin and come with complete documentation. Many
companies use the Wave Bioreactor in GMP operations and have received,
or are expecting regulatory approval. The Cellbag is ideal for GMP
production since it eliminates cleaning and sterilization validation
concerns. |
| Is it possible to grow attachment-dependent cells in the Wave Bioreactor? |
Cells do not stick to
the bag so it is necessary to introduce microcarriers into the bag.
Several users have reported good results with various commercial
microcarriers. See the literature section for published data. |
| What culture volumes are possible? |
Spans a range of 50 mL to 500 liters. SYSTEM2/10 takes CELLBAG.500mL (4 segments @ 50 mL - 250 mL), CELLBAG2L (0.1-1 liter) or CELLBAG10L (0.5-5 liters). SYSTEM20/50 with a KIT20 handles two CELLBAG2L, two CELLBAG10L (0.5-5 liters) or a single CELLBAG20L (1-10 liters). With a KIT50, a single CELLBAG50L (5-25liters) or two CELLBAG22L (1-10 liters) can be accommodated on this system. SYSTEM200 can use two CELLBAG100L (5-50 liters) or a single CELLBAG200L (10-100 liters). SYSTEM500/1000 can use two CELLBAG500L (50-250 liters) or a single CELLBAG1000L (100-500 liters). |
| How do I sample the bioreactor? |
Every Cellbag has a unique
sampling connector that can be used WITHOUT a biosafety cabinet.
A standard syringe (WITHOUT NEEDLE) can be used to add or withdraw
materials repeatedly during the culture. |
| How do I measure and control dissolved oxygen? |
We have special flexible fiber-optic dissolved oxygen probes (DOOPT-PROBE) that can be inserted aseptically into the Cellbag. |
| How do I control pH? |
pH can be controlled by
adjusting the CO2 content in the Cellbag headspace. The CO2MIX instrument
can provide 0-15% CO2 in air from a pure CO2 supply. An optional pH controller can also be purchased utilizing a special Cellbag containing a micro pH probe. The controller can operate an Acid/Base pump for precise pH control. |
| Can I do perfusion culture? How do I maintain constant liquid volume in the bag? |
Load cell options are
available for SYSTEM20/50 and 200 to provide online weight monitoring.
Pump control outputs can be used to trigger feed and harvest pumps
to maintain constant volume. |
| Are there any options for recording data and alarming? |
All Wave Bioreactors are
equipped with communication ports. These use a standard RS485 MODBUS
protocol which allows easy interface to user computer systems. Alternatively
our data acquisition software (PCDAQ) provides easy access to data
on Windows-based PCs. |
| Can I grow microbial cells in the Wave Bioreactor? |
Yes, with certain limitations. Please contact Wave for more information. There are currently applications using yeast and anaerobic organisms. |