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Integrated Cell Processing Workstation (CPWS)
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Integrated Cell Processing Workstation
Minimizes Cleanroom Expense
Quick to Acquire and Install
GMP and FDA Compliant for Aseptic Process
Energy Efficient, Green Design
The Essential Workstation for Cell Therapeutics
Continued worldwide development of new methods and processes in celltherapy and regenerative medicine requires renewed emphasis on tools andtechnologies required to establish and maintain aseptic conditionsdemanded of the clinical environment. Panasonic has met that challenge.
In designing the industry’s first viable alternative to a conventional Class 10,000 cleanroomfor both Class 100 air quality and barrier isolation, Panasonic has introduced the Cell ProcessingWork Station (CPWS) to bring the potential of cell therapeutics to more facilities whilemitigating acquisition and operation costs and protracted time lines.
Immediate beneficiaries of the Panasonic CPWS include both private andpublic institutions serving the life science, clinical, biotechnologyand pharmaceutical markets. These include mainstream and scale-uppharmaceutical companies focused on drug and medical device developmentrelated to human cells, medical researchers applying cellular therapiesin clinical trials, and hospitals now deploying FDA approved cellulartherapeutics to treat a broad range of diseases.
As the science progresses and results are propagated throughout themedical and scientific community, the need for bench-level research andproduction is expanding exponentially. As a result, the availability ofthe Panasonic free-standing, self-contained work station apart from theconventional layered cleanroom approach to containment and protection,is bringing the capability for on-site cellular therapeutics to morefacilities more quickly and at a lower capital and operational cost, allwithin the GMP performance envelope required of the cell technologyitself.
Self-Contained System, Small Footprint
The Panasonic concept of a self-contained work station is enabled by thecompany’s demonstrated proficiency for in situ decontamination requiredto separate processes from one patient to the next, or one protocol toanother. By using a highly effective H2O2 decontamination process, theCPWS can be completely decontaminated without heat and prepared for thenext protocol within two hours as compared to a cleanroomdecontamination function can take days or weeks.
By increasing throughput within the parameters of GMP compliance and FDAguidelines, the CPWS is deployed for both research, cellularmanipulation and growth, cell product extraction and emerging processesthat fall within similar guidelines.
Current and future applications of the CPWS include organ and tissueregeneration such as skin, cartilage, alveolar bone, cornea, cardiacmuscle, nerve, liver and pancreas regeneration. Immunotherapyapplications may extend to dendritic cells, T-cells and more.
Improving efficiency in human interaction is a primary design attributeof the CPWS. All work must be performed without human error, in anaseptic environment, and with detailed documentation to assure qualityand compliance. Gownup time, expense and inconvenience is minimized oreliminated altogether. Integrated systems within the CPWS permitcellular extraction, preparation, culturing and administration withaseptic assurance as well as economic practicality.
Because conventional autoclaving is not possible, the Panasonic H2O2decontamination process diminishes both time and labor associated withthis critical step between patients, positioning theCPWS squarely in the equation for cost/ benefit justification associatedwith investment decision-making. Allowances for integrated centrifuge,microscopy, data acquisition and incubation functionsare important considerations in the CPWS design; a unique dockingstation permits interface and exchange with unlimited number of cellculture incubators dedicated to individual patients orcell lines.
Minimize Surface Contamination
Since humans remain the single most common source of contamination, theCPWS provides both physical and process benefits to minimizecontamination and cross-contamination in the work
area. Within the four-port glove box the CPWS delivers more than aconventional Class II, Type A2 biological safety cabinet typicallyinstalled within a cleanroom to achieve the same objective. Here, themanually initiated, automatically deployed H2O2 decontamination processsupplements
continuous HEPA filtration. As 0.3 micron particles are removed from thefresh air exchange, H2O2 decontamination neutralizes contaminantsbrought forth by instrumentation or equipment.
A number of decontamination sequences are available to protect the aseptic environment.
The glove box design offers barrier isolation protection for theoperator and the work inside. User comfort and ergonomics are inherentto the CPWS design, including a sloped front for easier access and glarereduction.
Eliminates the Need for a Conventional Cleanroom
The relatively small footprint permits installation into existing or newClass 100,000 lab space with conventional utilities and minimal sitepreparation. Multi-layered airlocks in multiple treated rooms areavoided. Capital intensive expenses are lowered and lead times fromdecision to operation are shortened. Once in place, operational costsare highly contained and predictable, with decontamination availablemore frequently and at a fraction of conventional cost.
The Panasonic CPWS Workstation is designed to deliver efficient, cost effective and GMP compliant cell therapy and manufacturing capability without the expense and inconvenience of a cleanroom. The CPWS offers significant advantages over conventional hard wall cleanroom construction.
The Panasonic CPWS is a closed system, which requires only Class 100,000 air vs, an open system, which requires significant investment and maintenance of background environment,
The Lead Time and costs are minimal, just the cost of a Class 100,000 room plus CPWS vs. a traditional cleanroom which requires a Class 100,000 room, plus one or more Class 100 biological safety cabinets.
Minimal footprint in existing space with no requirements for HVAC, filtration, or air showers
Validation Costs are much lower, Class 100,000 is the only required vs. both Class 100 and Class 100,000.
Operational Costs are much lower for repeated decontamination and maintenance costs, plus no high consumables cost.
Implementation in weeks vs. years or months
No second gowning is required due to the easy access to the central barrier isolator with ergonomically angled front with glove ports. This reduces stress on the workforce.
Elimination of hazardous fumes for decontamination permits diverse applications. Elimination of depolymerizing formaldehyde, formalin and other toxic chemicals permits seamless transition between applications.
Expanded throughput- quick changeover extends use and optimizes return on investment. Component integration streamlines the workflow, while enhancing aseptic processing.
Decontamination in two hours vs. up to two weeks.
Microscopes and other instrumentation can be dedicated to the work station.
The Panasonic CPWS enables a broader access to cell therapeutics related to both minimally manipulated and non-minimally manipulated cell products by lowering the cost of entry, extending
the process to the widest range of applications, and minimizing operating expenses when compared to a conventional cleanroom environment.
Minimally manipulated products are associated with cell washing, enrichment, selection, HSC (PB, BM, CB), cancer therapies and other under GTP requirements.
Non-minimally manipulated products are associated with expanded, differentiated or transformed cells (DC, MSC, ESC, TC) in cancer centers, biotech labs, stem cell institutes and contract manufacturing facilities operating under GMP requirements.
GMPs (Good Manufacturing Practices) are mandated by the United States Food and Drug Administration to ensure that drug development and manufacturing is safe, quality controlled for repeatability and thoroughly documented.
GMPs typically require expensive hard wall laboratories and laboratory suites using biological safety cabinets in Class 10,000 cleanrooms surrounded by a Class 100,000 room.
Approximately 35% Less Expensive to Operate
The Panasonic CPWS offers significantly lower operating costs when compared to a conventional cleanroom (open system). Comparison methodology and assumptions are available from Panasonic. Softcost benefits related to user convenience and comfort, flexibility throughput and other demonstrated advantages of the CPWS can be established through consultative review. Contact Panasonic for details.
The barrier isolator forms the central component to the work station and contains the primary operating systems required to establish and maintain aseptic conditions to meet GMP criteria.
The barrier completely isolates the interior work product from the operator.
The barrier isolator creates a closed Class 100 environment, eliminating the need for biological safety cabinets in a cleanroom.
Isolator interior air is 100% Class 100 total circulation; no recirculated air is used.
The polished stainless steel glove box interior is designed for maximum exposure of all interior surfaces subject to H2O2 decontamination.
Before commissioning and initial use, the isolator front can be opened on a hinged frame for installation of instrumentation or other devices larger than the interchange pass box opening.
The HEPA filter and airflow system is mounted on top of the isolator.
The internal airflow system is designed to create a positive pressure to mitigate the possibility of inflow contamination.
Viability of the containment area is not deferred to third-party contractors who are hired to clean and decontaminate.
Ergonomics and Safety
Because second gowning is not required, user comfort and productivity is significantly improved. The workplace routine, including bathroom breaks, is unencumbered by the need to leave and re-enter a cleanroom, bleach and/or shower.
The inconvenience and expense of cumbersome containments suits with air and vacuum hoses is eliminated. If working with BL3 agents, the buddy system is not required.
The barrier eliminates the potential for room contamination from blood or other
aerosols. Workflow is not impacted by routine colds.
Staff confidence in total containment improves morale.
Glove ports permit easier handling of red bag materials when required.
A 6° angled front includes three glove ports to permit access to all interior surfaces.
The interior cabinet includes independent interior fluorescent lamps to supplement ambient light.
Aseptic Environment Required for Cell Preparation
Usually, human derived cells must be guaranteed that they are prepared and cultured in an aseptic environment because they cannot be treated by heat or pressure.
H2O2 Decontamination System
The manually initiated, automatically sequenced H2O2 decontamination system offers a fast, safe and proven decontamination process to enhance the performance of the CPSC by allowing more frequent turnover of segregated cell lines.
The validated H2O2 system generates an H2O2 vapor that permeates all exposed surfaces from the central interchange pass box nebulizer containing a replaceable bottle of enriched hydrogen peroxide.
When deployed, the H2O2 vaporization sequence decontaminates the pass box, work station interior, centrifuge and CO2 incubator exterior and docking gaskets.
Once the vaporization is complete, the H2O2 program implements a dwell period to ensure that proper exposure times are maintained for a wide range of pathogens (contact Panasonic for independent test results).
At the end of the pre-programmed dwell period a resolution process eliminates fumes and toxic residuals.
The interchange pass box allows safe access to the work area for supplies, instruments, devices, sterile media and labware.
When materials are brought into the work station they are first positioned inside the interchange for H2O2 decontamination.
Decontamination is manually initiated and automatically sequenced once started.
When the H2O2 vaporization process is complete, the inner door is opened and the transfer is completed.
Door interlocks permit simultaneous opening to protect the barrier isolator.
Conventional GMP Cleanroom Facility (Open System) with Biological Safety Cabinets
The modular CO2 incubator is an adaptation of the full-performance Panasonic MCO-5AC(IS). This incubator is designed for precise temperature and CO2 control with elevated relative humidity to minimize cell desiccation.
By using multiple, detachable CO2 incubators, the CPWS can manage multiple patient protocols through complete product segregation, thereby assuring aseptic conditions and eliminating any possibility of cross contamination or mishandling of patient-specific cells.
Segregation permits compliance with published FDA criteria associated with regenerative medicine and in vivo cell therapies.
The incubator attaches to a docking collar adjacent to the barrier isolator.
Once attached, the barrier isolator undergoes a 2-hour H2O2 decontamination process before the incubator door is opened. This process decontaminates the work area, incubator face, centrifuge and pass-thru interchange.
The H2O2 effectively decontaminates the CO2 connection.
When work is complete, the incubator is sealed, detached and moved to a user-defined staging location on a wheeled cart.
The next incubator can be moved into position to repeat the process for another patient.
There is no limit to the number of Panasonic MCO-5AC(IS) incubators that can be used with the workstation.
Incubator Features and Benefits
The incubator is a modification of Panasonic’s popular MCO-5AC. The compact 1.4 cu.ft. (49 liter) interior chamber is constructed of Panasonic’s exclusive inCu saFe copper enriched stainless steel, creating a natural germicidal barrier against airborne contamination.
An integrated microprocessor controller supervises all functions including temperature and CO2 setpoints, control, alarm and monitoring.
The patented Direct Heat and Air Jacket control system assures temperature uniformity and stability essential to the most sensitive cell lines.
The rounded-corner, electropolished interior is configured for use with a variety of standard cell culture vessels.
All interior components are designed to withstand repeated H2O2 decontamination cycles expected in high turnover environments. Components are removable without tools.
The centrifuge is installed beneath the interior work surface and accessible under aseptic conditions without removing cells from the protected environment.
The position and orientation of the centrifuge assures thorough decontamination during the H2O2 vaporization cycle.
The integrated design eliminates the requirement for additional floor space in a GMP environment.
A variety of fixed and swinging rotors is available.
Centrifuge controls are located external to the work area at the front of the centrifuge module.
A total H2O2 vapor decontamination creates aseptic conditions in the interchange pass box, the glove box and (optional) centrifuge module.
Pass Box Only
- Instruments or materials introduced into the glove box are decontaminated by a pass box cycle only, avoiding the need to decontaminate the entire glove box work area. Work can
continue in the glove box while the cycle is in process.
Cell Culture Incubator
- Incubator and Work Area. After aseptic protocols are completed, cultures are transferred to the (optional) CO2 incubator where growth can continue under aseptic conditions
after the incubator is detached. Unwanted materials are removed through the pass box interchange.
- When handling different cells from the previous protocol, the next (optional) cell culture incubator is docked to the workstation glove box. The workstation, interchange pass box (optional) centrifuge and incubator door are decontaminated prior to opening. The changeover process is completed in less than two hours.
Cell Monitoring System (Optional)
An integrated cell monitoring system reduces additional footprint required in a GMP environment. Cell monitor components are located within the barrier isolator and designed to withstand repeated H2O2 decontamination sequences.
The interior components include a large, 19” LCD monitor, and a separate collection module.
The collection module includes a high-performance CCD camera (charge coupled device) with objective lens and phase difference filter.
The monitor displays real time images with total magnification of 110×.
Images can be captured via a noncontact photo sensor, 2.4 × 1.8mm for monitor display and digital recording.
A standard personal computer external to the aseptic isolator work area is used for data acquisition and image management.
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