Advanced Analytical (AATI)

The fully automated RBD3000 allows for rapid bacterial detection with unparalleled speed, accuracy and ease of use. This patented system tests for Total Viable Organisms, Biomass and Specific Pathogens with just the touch of a button. Our state-of-the-art device can detect cells of 0.1microns and larger with a detection limit down to 10 CFU/ml. The AATI world-class Research and Development Group has produced simple testing methods and associated test kits that ensure accurate and precise results in a minimum amount of time.

The microbial fermentation industry holds significant interest in real-time enumeration of biomass. Cell mass and viability monitoring allows the scientist to harvest cultures at times that are optimal for the best product yield. Typical sampling points include starter cultures, fermentation cultures (pre- and post-inactivation), downstream processing, and after formulation with an adjuvant. The RBD 3000 provides critical information, unavailable by conventional plate count methods, since it can measure both biomass and inactivated cultures.

Other key features to the entire line are:

• Excellent tool for real-time enumeration of biomass and viability, thereby providing critical information, which is unavailable by conventional methods.
• 36-position sample rack for unattended routing operation
• Additional 6-position sample rack for optional priority testing for samples requiring urgent results
• The electronic and optical design of the RBD3000 has resulted in an instrument that is both rugged and sensitive and equally well suited for both the production floor and the laboratory
• The software provided with the RBD3000 is user-friendly and dynamic with multiple access levels.
• Sample handling protocols for unattended operation
• Disposable syringes and sample vials eliminate cross-contamination
• Consistently correlates with conventional methods
• 21 CFR Part 11 compliant
• Sample throughput of Total Viable Organism is achievable within 15 minutes
• Applications include: Clean water testing, efficacy studies, fermentation applications, cell culture media testing, mycoplasma detection, just to name a few.
• A variety of microorganisms – Mycoplasma, gram positive and negative bacteria, a spirochete, and yeast were successfully analyzed with the RBD technology to demonstrate the dynamic range of the instrument to accurately enumerate various microbes in culture.

The BioQuest Benchtop Bioreactors, which are used for both mammalian cell and microbial fermentations, are the most versatile and easy to use systems available. Although we have three different models to choose from, each system already comes with high quality components, standard measurement probes, large easy-viewing touchscreen, full logging & data export capability, and graphical layouts.

Other key features to the entire line are:

• Large color touch screen with point of use, human interface. Each reactor has an on-board computer with data acquisition and control.
• The large touch screen user interface allows for easy run-time viewing of all parameters from a glance. Furthermore, you can view a detailed snapshot of your process, a rolling chart recorder screen or even examine your historical data.
• Each unit is capable of multi level cascade control loops for all normally used control parameters (eg: pH, DO, foam/level, sterilization cycles, calibration, agitation, etc.).
• Comes with the ability to connect other manufacturer’s instruments and use them for control loop feedback / strategies. Some of these items include; OD probes, glucose analyzers (eg. Trace Biotech), mass spec, HPLC, balances, etc.
• We can easily and inexpensively incorporate communications protocols for other equipment that has not been interfaced in the past.
• All controllers generally use a “PID” algorithm, which come pre-tuned plus have auto-tuning capabilities.
• Each system is able to determine and use run time values such as: Kla, OUR, and RQ’s. We have a dedicated off gas analyzer (DUET) that will give you real time gas stream readings for CO 2 and O 2. These of course can be fed back to control loops.
• The Graphical User Interface is truly intuitive. Anyone with Bioreactor experience could set up an initial run / control cycle without trainin

The Duet, which can be used in all lab, pilot and production environments, will accurately measure concentrations of Oxygen (O2) and Carbon Dioxide (CO2) gases in any gas stream. The Duets' on-line information, allows real time calculation of variables such as CER, OUR, RQ, growth rate, KLa, etc. This instrument will, therefore, detect small changes in metabolic activity often missed by other systems and will allow for feeding based on the metabolic activity of your cells.

• Will help you make better control decisions to your process at a reasonable cost
• Dedicated on-line gas analysis allows you to obtain vital information as well as real time feedback control
• Simple to install and easy to use
• The Duet is a dedicated instrument, which is not multiplexed. A malfunction in one instrument will only affect data from one fermenter, not all fermenters.
• Helps make scale-up and scale-down predictions
• Temperature compensation
• Local display of O2, CO2 and temperature
• Comes at a price similar to other standard sensors, saving a substantial amount of money.
• The Duets' continuous measurement of exhaust gas allows you to trace your process activity in greater detail and to optimize the development of your method.
• Will help provide you with a greater understanding of your cells and processes

Introducing the first disposable paddle spinner systems for both suspension and attachment cell lines. These systems, which come gamma irradiated, offer you ready-to-use convenience and the complete confidence of a clean and sterile system.

• Ready-to-use convenience. Simply remove the Tyvek pouch and use
• No complicated and time consuming assembly or disassembly of paddle drive parts as in conventional glass spinners
• Economical and cost effective
• Each system is gamma irradiated. Each unit offers complete confidence in sterility, eliminating all contamination risks associated with detergent cleaning.
• USP XXXIII, Class VI Polystyrene. Compatible for growth of all cell types as cultured in conventional glass spinners
• The paddle size and height is optimized to the vessel dimensions of 2 different sizes of minimum working volumes 125ml and 500ml respectively
• Integrated shaft with top cap provides fixed shaft height. Therefore, no validation issues associated with height adjustments
• Standard side arm cap
  

• A miniaturized spinner system which supports the efficient growth of adherent cells in vitro
• Supplied ready-to-use
• The Starwheel TM uses a unique three-dimensional scaffold called the Dynamtatrix TM , which is made of an inert material, carbon and coated with Niobium
• The scaffold resembles bone marrow structure with a lattice of open pores and continuous channels with no blind ends or dead spaces
• This Bio-mimetic environment simulates an ideal in vivo micro-environment for normal cell-cell physiological associations enhancing overall cell growth and viability
• High porous material allows for optimum adherent surface area and media exchange within the matrix
• Continuous channels allows nutrient media to infiltrate the entire matrix, ensuring that media exchange is optimal and maintained throughout the structure
• It is this combination of architecture and mass transfer that simulates an ideal in- vivo growth environment, enabling cells to thrive even in cytokine-free media to achieve tissue-like growth densities
• This unique system is able to sustain increased growth density, increased levels of expressed products and increased cell viability when compared to other culture systems
• Up to 32 disks can be loaded providing an adherent surface area of approximately 60 – 70cm 2 /cm 3 per disk
• Cell densities reach 3-8 x 10 8 cells per ml, making this miniaturized approach to bio-production a major advantage in scaling up.
• Each disk provides for easy and convenient handling and processing.
• In-Situ visualization is possible by staining the disks using standard staining procedures.
• Cryo-preservation is done exactly as for a cell pellet without the need to have the cells removed from the disks
• Because true aliquots of cells from disk to disk are highly consistent with reproducible cell growth, process validation is made simple and easy

• Designed specifically to measure and control difficult foam conditions.
• The foam sensor utilizes a unique technology which allows the sensor to keep working even with a high degree of foaling.
• Charis maintains a wide range of foam sensors and controllers depending on your applications.
• Reduces downtime and product loss, lowers antifoam costs, improves vessel utilization and reduces operator intervention
• Reliable and Hygienic
• FDA approved materials

Issues of maximizing protein yield, creating lot-to-lot consistency, and building cost-effective production processes, have created the need for ultra-efficient protein analysis solutions. A key component of these efforts is the development of automated instrumentation that can provide rapid process monitoring and process feedback control to the reaction vessel. Essential to this is the need to perform the analytical process on a real-time basis, using online, in-line and noninvasive methods to eliminate the potential for human contamination and error, as well as reduce labor and improve yield. The GPA1000 Process Analyzer and the Automated Reactor sampling System (ARS) are complementary online systems, which address these needs.

The ARS and GPA1000 systems are designed to automate the manual, labor-intensive sampling, purification, analysis and feedback processes, so that these operations can be performed with a minimum of operator interaction. Appreciable labor savings can be realized by automating the sampling and processing steps. These systems will provide a means to improve bio reactor monitoring, process development, and product quality and yield.

• The Automated Reactor Sampling System is designed to provide fully programmable sampling of a reaction vessel or vessels on a user-scheduled basis.
• The system includes a valving network and precision pump for sampling and cleaning while simultaneously insuring protection against reactor contamination.
• Up to four bioreactors can be multiplexed into a single ARS manifold system.
• It can operate on a 24-hour/7-day basis, thereby eliminating the need for manual sampling, which is labor intensive and prone to operator error.
• All ARS components are CIP-compatible and 21 CFR compliant.
• Production systems can also perform SIP.
• Samples obtained from bioreactors by the ARS can be delivered to a cooled autosampler, a cell counter, nutrient monitor, HPLC, CE, or other analytical instrument.

• The GPA1000 Process Analyzer is a flexible system that can be adapted to the analysis of a broad range of proteins, amino acids, nutrients and metabolites in as little as 45 minutes.
• Protocols are being developed for the analysis of twenty amino acids, vitamins, anions, cations and trace metals.
• The system can perform the following processes: Rough and fine filtering, buffer exchange, desorption of sample from the filter, buffering, dilution/concentration, denaturing, reagent addition and detection
• The protocol can be designed to analyze either the low-molecular-weight filtrate that is removed by the desalting filter, or the high-molecular-weight compound retained by the filter. If desired, both of these components can be analyzed sequentially or in parallel.
• The GPA1000 reduces method development time, enhances product yield, and helps avoid batch failures.
• Fully automatic on-line operation, including clean-in-place procedures and calibrations.
• Secure data streams – 21CFR Part 11 compliant
• Full control, acquisition, and data analysis software
• Remote system operation and monitoring via Ethernet

Clean steam traps, site glasses and Sample Coolers

Clean steam traps offer a number of unique features including:

• Screwed body design.
• 316/316L stainless steel construction.
• Crevice-free design.
• Near-to steam operating characteristics.
• Wide range of connection options.
• Choice of surface finishes.
• Optimal design stops any possible leakage.

Bioprocess Analyzers and Sampling Probes

The analysis of nutrient and metabolite concentrations is essential during cell cultivations and fermentations. Accurate, fast and real time measurements guarantee the best control and therefore help increase production capacities and lower running costs. TRACE Analytics introduces several different Nutrient and Metabolite solutions which will best suit your bioprocess needs:

PicoTRACE – Low cost, mobile and handy analysis on the spot.
LaboTRACE – Analysis system for up to 30 samples.
ProcessTRACE – On-line measurements of nutrients with a sterile sampling system of your choice.

Filtration probe ESIP – No sample preparation is required with the low volume, sterile filtration probe.
Dialysis Probe – No sample preparation is required and no volume is consumed with this robust and sterile dialysis probe.

Trace Bioprocess Analyzers:
PicoTrace

• Simultaneous determination of glucose and lactate in cell cultivation's and fermentations.
• The PicoTRACE is a high quality, lightweight and battery operated system, which can be carried directly to the bio reactor or wherever it is needed.
• At-line analysis on the spot.
• The end user will get results in less than one minute after sampling!
• Less chance of incorrect measurements caused by a time lag between sampling and actual measurement.
• The system is easy to use: Just take a sample directly from the bio reactor, remove cells if necessary, put an aliquot into a small test tube and insert it into the PicoTrace.
• Calibrations, measurements and cleaning cycles will be done automatically.
• Low investment and running costs.
• Small sampling volume (10-20µl).

• An automatic analyzer for the simultaneous determination of glucose and lactate in cell cultivation's and fermentations.
• LaboTRACE is the perfect solution for daily analysis in the lab.
• The well proven biosensor technology guarantees fast and accurate results in less then one minute.
• The device is simple to handle, easy to operate and requires little service. All users are thus able to achieve analysis results that meet the highest quality demands.
• The system is easy to use: Just take a sample directly from the bio reactor, remove cells if necessary, put an aliquot into a small test tube and insert it into the LaboTRACE. After pressing the Menu button, the measurement starts.
• Calibrations, measurements and cleaning cycles will be done automatically.
• LaboTRACE can be offered in two versions: Up to 8 samples or up to 30 samples.
• Low investment and running costs.
• Small sampling volume (10-20µl).

• Used primarily for on-line analysis of glucose in cell cultivation's and fermentations.
• Also able to analyze other analytes such as: Methanol, Ethanol, Lactate or Sucrose on-line.
• The samples to the ProcessTRACE can be drawn under sterile conditions from the bio reactor, while ensuring reproducibility and relevance of sample taken via their patented dialysis probe or filtration probe.
• Both withdrawal methods guarantee sterile sampling without any previous sample preparation.
• On-line analysis will allow fast and continuous measurements as well as optimization of feeding strategies.
• An option is available for the parallel measurement of up to six bio reactors. Measurement intervals from 5 minutes to 24 hours can be selected as desired, irrespective of the channel.
• Measurement frequency of up to 30 samples per hour.
• System runs automatically including calibration routine

Trace Sampling Systems
Dialysis Probe

• Sample transfer takes place through a dialysis membrane in the dialysis probe, which separates the reactor contents (medium) from the acceptor stream. At the same time, the dialysis membrane represents the sterile barrier. The acceptor stream accumulates the target molecules inside the dialysis probe.
• No volume consumed for sampling.
• No sample preparation required
• Robust dialysis membrane allows for sterile dialysis with no solids and proteins >14 kDa.
• Can be installed in 12, 19 and 25mm ports.
• Especially suited for small bio reactors with volume <50L.
• Samples are representative.
• Low biofilm affinity.
• To be used with on-line and off-line analyzers

• The filtration probe ESIP is designed to withdraw sterile, cell-free filtrate from fermenters and bio reactors.
• The tubular micro-filtration polypropylene membrane, supported by a stainless steel probe, is positioned inside the reaction vessel.
• The ESIP is sterilized together with the fermenter/bio reactor.
• Can be configured in standard 12mm, 19mm or 25mm ports
• Sterile cell-free filtrate can be withdrawn intermittently or continuously, manually or automatically.
• Extension modules are available for adjusting the module’s length to meet your specific requirements .
• Low dead volume.
• No sample preparation is required.
• Samples are representative.
• To be used with on-line and off-line analyzers.
  

Bioreactor Sampling Valve

• Seal life is guaranteed for 2 years. Ensures maintenance free operation.
• Streamlined internal flow path with internal volume of less than 2mls. Therefore, minimum product waste
• No dead volume
  
• Process sample is obtained in complete isolation and safety. The process fluid does not come in contact with the valves operating components
• Valve may be steam-sterilized continuously.
• Easy operation. No separate steam shutoff valve
  required.
  

• Applications for fermentation, chromatography, filtration and centrifugation.
• Cell growth monitor and probe provides accurate cell density measurement in-situ.
• Works for mammalian cell cultures as well as microbial cultures
• Chromatography column monitoring and logging
  System. Includes UV, conuctivity, temperature and pH.
• Analyzers include: UV, Conductivity, Temperature,
  Turbidity, solids, Color and Florescence.