The biopharmaceutical industry is gaining momentum, as an increasing number of biological products are being investigated as treatment modalities for a broad range of diseases. It is estimated that within five to ten years, biopharmaceuticals will constitute approximately 50 percent of all drugs in development. Biopharmaceuticals offer several advantages over small molecule drugs, including their high specificity and affinity to their therapeutic targets, and thus the reduced risk of adverse “off-target” effects. Biopharmaceutical production typically consists of four stages (production, harvest, purification and formulation/fill), which in turn involve a variety of techniques.
Contamination Control
The manufacture of biotherapeutic products from living cells is a complex, multi-step process that requires meticulous planning and a well-trained workforce. In addition to posing a significant risk to the quality and safety of biotherapeutic products, there is an enormous cost for facilities that may have to shut down for extended periods to identify the root cause of contamination.
Effective control therefore relies on a comprehensive understanding of potential microbial, chemical or physical contaminant entry points and general risks to the process, in addition to the microbial growth potential of the media, buffer solutions and product itself. Measures such as (1) appropriate facility and equipment design; (2) validated cleaning and sterilization cycles for equipment; (3) detailed and robust preventative maintenance equipment plans; (4) measures to monitor and reduce bioburden and bacterial endotoxin; and (5) establishing a contamination remediation plan, are necessary to meet GMPs and reduce facility downtime.
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“Potential Financial Impact of a Bioburden Incident during Biopharmaceutical Manufacturing”
| Issue |
Estimated impact and cost |
| Commercial impact |
Up to $1 B in lost revenue per month for blockbuster drugs Loss of reputation and business Penalties (in rare cases) Inaccurate or erroneous experimental results |
| Failed production lot/scrapped batch |
Up to $1 M (based on 2000 L bioreactor with 5 g/L expression level and a cost of $100/g for monoclonal antibody production). |
| QA investigation |
Up to $20,000 in labor cost (this equates to approximately one week of investigation by three people at a rate of $120/h). |
| Sanitization of facility and equipment |
Up to $100,000 in labor cost (this equates to four weeks of work by five people at a rate of $120/h). |
| Discarded resin |
Up to $3 M (based on large-scale column size and resin costs). |
*Costs in U.S. dollars (USD). M = Million USD, B = Billion USD
“ISO Classifications and Good Manufacturing Practices (GMPs)”
Cleanrooms are used to control the concentration of airborne particles during contamination-sensitive activities in industries such as pharmaceuticals, biotechnology, medical devices, healthcare and food. Air cleanliness in cleanrooms is classified according to the International Organization for Standardization (ISO), a worldwide federation comprised of national standards bodies, based on cumulative distributions of particle populations that range in sizes from ≥ 0.1 µm to 5 µm.
ISO Classifications Explained: Click to Expand Click to Expand
While maintaining laboratory quality standards has always been critical, the increased focus on strictly controlled environments will continue to expand with stem cell research and regenerative medicine demands. Therefore, as cleanroom certification for GMP manufacturing grows in importance, it is vital to select core laboratory equipment that meets ISO certifications and facilitates cleanroom status.
CO₂ and Multi-Gas Incubators
Our MCO Incubators (MCO-170AICUVHL and MCO-230AICUVL) are ISO Class 5.0 classified and use the PHCbi brand Direct Heat and Air Jacket system for precise temperature control. The MCO-80IC is ISO Class 5.5 classified and provides a large capacity with minimal CO2 consumption. PHCbi’s CO2 and multi-gas incubators offer optimal solutions for in vitro cell culture production and they can be equipped with H2O2 vapor decontamination or a SafeCell UV light lamp to further guard against contamination.
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- Zirconia O2 Sensor
The unique, solid state Zirconia O2 sensor delivers precise oxygen control.
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- H2O2 Decontamination
The unique H2O2 decontamination system delivers fast and validatable decontamination.
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- Integrated Tray Catches
Significantly minimize cleaning time and improves productivity.
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- IR CO2 Sensor
The IR CO2 Sensor offers accurate and reliable CO2 measurement.
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- Dual IR CO2 Sensor
The single beam, dual detector IR CO2 Sensor offers continuous calibration for excellent control, accuracy and stability.
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- SafeCell UV Lamp
The SafeCell UV lamp prevents contamination.
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- inCu-saFe germicidal interior
inCu-saFe germicidal interior prevents contamination.
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- Dual Heat Sterilisation
Two independent heaters enable cell culturing to continue uninterrupted during sterilization.
- 1. Click or Tap on icons to expand on model information
- 2. Click to download brochure and/or operating manual
- 3. Check out our Comparison Specification Chart: Click to Expand
- 4. Read our Choosing Your Cell Incubator: Here
Click to View Product Line-up
InCusaFe CO2 Incubators with H202 decontamination Redefines Productivity
How does H202 Decontamination works
Ultra-Low Temperature Freezers(-86°C)
The upright -80°C freezer is ISO Class 6.0 classified and ideal for the long-term storage of vaccines, cell cultures and tissues, rare specimens, biological materials and other high valued products.
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- Inverter Compressors
Inverter Compressors maximise cooling performance and reduce energy consumption.
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- VIP PLUS vacuum insulation
VIP PLUS vacuum insulation maximises storage capacity.
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- A full-color LCD Touch Panel
Various functions such as logging the temperature history, and setting up passwords and alarms can all be managed on the screen.
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- EZlatch Easy Acces Door Handle
The EZlatch makes access to stored samples even easier.
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- Natural Refrigerants
Naturally occurring hydrocarbon (HC) refrigerants improve performance and reduce running costs.
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- Dual Cooling System
Dual Cooling System offers ultimate sample protection.
- 5. Click or Tap on icons to expand on model information
- 6. Click to download brochure and/or operating manual
- 7. Check out our Comparison Specification Chart: Click to Expand
- 8. Read our Points to Consider when Purchasing a ULT: Download PDF
Click to View Product Line-up
TwinGuard ULT Freezers
MDF-DU302VX | MDF-DU502VX | MDF-DU702VX
- Effective capacity
- 360L / 528L / 729L
- Cooling Performance
- -86℃ to -50℃
The most secure ultra-low temperature freezers for the storage of high value samplesTwinGuard Ultra Low Temperature Freezers with Dual Cooling Technology offers the highest level of security for high-value samples. Alongside exceptional ease-of-use and data monitoring, the Dual Cooling System provides the highest level of protection through the use of two independent refrigeration systems. If one system unexpectedly fails, the other can maintain the freezer’s temperature uniformly in the -70˚C range.
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VIP ECO ULT Freezers
MDF-DU502VH | MDF-DU702VH | MDF-DU901VH
- Available Capacity
- 528L / 729L / 845L
- Cooling Performance
- -86℃ to -40℃ / MDF-DU901VH: -86℃ to -50℃
The cost-saving and environmentally friendly sample storage within an optimal footprintVIP ECO, unlike conventional ultra-lower freezers, utilizes natural hydrocarbon (HC) refrigerants to provide minimal energy consumption, reduced environmental impact and substantially lower running costs. HC refrigerants have a high latent heat of evaporation making them much more efficient at removing heat from the freezer chamber than conventional refrigerants, resulting in up to a 55% reduction in energy consumption and costs. THE VIP ECO helps organizations to meet environmental objectives.
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PRO ECO Freezers
MDF-DU300H
- Available Capacity
- 333L
- Cooling Performance
- -86℃ to -50℃
The space and cost-saving eco-friendly sample storageThe PRO ECO Freezers, our space-saving and eco-friendly freezer, offer a heat exchanger design for greater surface area contact and overall efficiency. The PRO ECO -86°C ultra-low freezer is part of our range of ECO ultra-low freezers with natural refrigerants. They help to minimize energy consumption, reduce environmental impact and are cost-efficient.
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VIP ULT Freezers
MDF-C8V1 | MDF-U74V | MDF-DU900V
- Available Capacity
- 84L / 728L / 845L
- Cooling Performance
- -86℃ to -50℃
The sample storage that maximizes on storage capacity with high thermal resistanceThe VIP ultra-low temperature freezer series are an economical choice when selecting a ult that achieves 30% more storage capacity than conventional insulated freezers along with 6 times stronger thermal resistance. The VIP series contain densely packed, open cell foam insulation under the vacuum panel. This configuration dramatically enhances the insulation capability of the freezer while reducing the wall thickness.
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PRO ULT Freezers
MDF-DC700VX
- Available Capacity
- Chest: Chest: 701L
- Cooling Performance
- -86℃ to -50℃
The most secure ultra-low temperature freezers for the storage of high value samplesTwinGuard Ultra Low Temperature Freezers with Dual Cooling Technology offers the highest level of security for high-value samples. Alongside exceptional ease-of-use and data monitoring, the Dual Cooling System provides the highest level of protection through the use of two independent refrigeration systems. If one system unexpectedly fails, the other can maintain the freezer’s temperature uniformly in the -70˚C range.
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| TwinGuard |
VIP ECO |
PRO ECO |
VIP |
TwinGuard |
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| Manual |
Manual |
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Laboratory Freezers(-30/-40°C)
PHCbi has been supplying worldwide leading research and healthcare organisations with advanced biomedical freezers for over 30 years. More customers than ever before are choosing our -30 and -40 degrees’ Celsius freezers as their vaccine, plasma and sample storage solution. With an industry-leading reputation for high performance and reliability, our medical freezers provide a variety of options ranging from uniform temperature control, energy efficiency, as well as complete overall versatility. Our customers have continued to choose our industrial medical freezers that come with dedicated technical support and a high level of after-care services.
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- Inverter Compressors
Inverter Compressors maximise cooling performance and reduce energy consumption.
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- Natural Refrigerants
Naturally occurring hydrocarbon (HC) refrigerants improve performance and reduce running costs.
- 1. Click or Tap on icons to expand on model information
- 2. Click to download brochure and/or operating manual
- 3. Click to check out our easy Comparison Specification Chart: Click to Expand
Click to View Product Line-up
Biomedical -30℃ Freezers
MDF-MU339 | MDF-MU539 | MDF-549D
- Effective capacity
- 369L / 504L / 479L
- Temperature range
- 20℃ to -30℃ / MDF-MU549DHL: -20℃ to -40℃
The stable -30°C environment with extensive storage possibilities. The MDF-MU339, MDF-MU539, and MDF-MU549D ECO freezer provides effective storage of life-saving vaccines and samples for diagnosis. They can also be used for storage of enzymes for genetic research, as well as culture media, reagents and samples for testing. PHCbi Biomedical freezers are also ideal for industrial aging and temperature tests. As a storage environment, with excellent safety and other easy-to-use features, these freezers offer unsurpassed reliability and functionality.
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ECO Biomedical -30℃ Freezers
MDF-MU339HL | MDF-MU539HL
- Effective capacity
- 369L / 504L
- Temperature range
- 20℃ to -30℃
The eco-friendly and cost-efficient -30°C freezer with extensive versatility.The MDF-MU339HL and MDF-MU539HL ECO freezer provides effective storage of life-saving vaccines and samples for diagnosis. They can also be used for storage of enzymes for genetic research, as well as culture media, reagents and samples for testing. PHCbi Biomedical freezers are also ideal for industrial aging and temperature tests. As a storage environment, with excellent safety and other easy-to-use features, these freezers offer unsurpassed reliability and functionality.
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Biomedical -30℃ Chest Freezers
MDF-137 | MDF-237 | MDF-437
- Effective capacity
- 138L / 221L / 425L
- Temperature range
- -20℃ to -30℃
The chest-style freezers with the power to counteract frequent door openings.The MDF-137, MDF-237, and MDF-437 Biomedical Freezers offer outstanding uniform temperature control of up to -30℃ with reliable performance required in a wide variety of storage and research applications. This storage environment has excellent safety features and is easy to operate.
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Biomedical -30℃ Freezers
MDF-U731 | MDF-U731M
- Effective capacity
- 623L / 690L
- Temperature range
- -20℃ to -30℃
The spacious and large capacity -30°C Biomedical Freezer for maximum sample storage.The MDF-U731/MDF-U731M is a large-capacity Biomedical Freezer, with a direct cooling system and manual defrost. The MDF-U731/MDF-U731M Biomedical Freezer is designed with all the features for “Plug-in and Go” laboratory grade freezing of enzymes, vaccines, and other biologics.
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ECO Biomedical -40℃ Freezers with Dual Control
MDF-MU549DHL
- Effective capacity
- 479L
- Temperature range
- 20℃ to -40℃
The -40°C ECO Biomedical Freezer with separate temperature controls for separate independent chambersThe MDF-MU549DHL, also known as our ECO Plasma Freezer, provides environmental saving and flexibility while maintaining the quality of the samples during preservation. Such flexibility includes height-adjustable shelf trays, separate top and bottom chambers with independent temperature settings and separate doors that prevent cold air leakage. This freezer utilizes natural refrigerants to minimize energy consumption, reduce environmental impact and save money while providing superior stability and uniformity.
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| MDF -30°C Series |
MDF ECO Series -30°C |
MDF -30°C Chest |
Large Capacity
-30°C |
ECO & Dual -40℃ Temperature Control |
MDF-MU339
MDF-MU539
MDF-MU539D |
MDF-MU339HL
MDF-MU539HL |
MDF-137
MDF-237
MDF-437 |
MDF-U731
MDF-U731M |
MDF-MU549DHL |
| Brochure |
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| Manual |
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MPR Pharmaceutical Refrigerators
Since the launch of our first Pharmaceutical Refrigerator model in 1966, PHCbi have taken advantage of this technology to create exceptional products and services with a high degree of quality and reliability. PHCbi has been supplying worldwide leading research and healthcare organisations with advanced pharmaceutical refrigerators that meet hospital standards around the world. Our pharmaceutical refrigerators offer safe and uniform temperature control that are precisely regulated for both medicinal storage and storage for pharmaceutics. The PHCbi branded pharmaceutical refrigerators for vaccine storage have continuously been sought after. Our customers have continued to choose our pharmaceutical refrigerators that come with dedicated technical support and a high level of after-care services.
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- Inverter Compressors
Inverter Compressors maximise cooling performance and reduce energy consumption.
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- Natural Refrigerants
Naturally occurring hydrocarbon (HC) refrigerants improve performance and reduce running costs.
- 1. Click or Tap on icons to expand on model information
- 2. Click to download brochure and/or operating manual
- 3. Click to check out our easy comparison specification chart: Click to Expand
Click to View Product Line-up
| New Condensation Reduction Glass |
Freezer/Fridge Combo
-20℃ to -30℃/ 2℃ to 14℃ |
Large Capacity |
Cost-Effective |
ECO MPR Sliding Door Pharmaceutical Refrigerators
MPR-S150H | MPR-S300H | MPR-S500H
- Effective capacity
- 165L / 345L / 554L
- Temperature range
- +2℃ to +14℃
The uniform temperature storage refrigerator for the most demanding applicationsMPR-S150H, MPR-S300H, and MPR-S500H Pharmaceutical Refrigerators offer a complete solution for the most demanding requirements for storage of pharmaceuticals, medicines, vaccines, and other temperature-sensitive applications. With two built-in argon gas-filled glass panels, this newly designed fridge reduces condensation to make it easier to see everything you need.
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MPR Pharmaceutical Refrigerator with Freezer
MPR-N450FH | MPR-N450FSH
- Effective capacity
- 136L (Ref) & 80L (Frz)
- Temperature range
- +2℃ to +14℃ (Ref) & -20℃ to -30℃ (Frz)
Providing a complete storage solution – a refrigerator and freezer in one unit.The MPR-N450FH/MPR-N450FSH combine high-performance refrigeration with a -30°C freezing environment within a small footprint for flexible, reliable and convenient sample storage. Natural refrigerants minimize environmental impact for a sustainable storage solution. The MPR-N450 comes in either glass doors (FH) or solid steel doors (FSH).
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MPR Pharmaceutical Refrigerators
MPR-722 | MPR-1412
- Effective capacity
- 684L / 1,364L
- Temperature range
- +2℃ to +23℃
The airflow assures quick recovery and interior uniformity paired with large storage capacityThe MPR-722 and MPR-1412 large capacity Pharmaceutical Refrigerators (with wiring shelves) delivers stable, reliable temperature control for clinical, pharmaceutical, biomedical storage and processing. With a temperature range of 2°C to 23°C, the MPR-722 and MPR-1412 Pharmaceutical Refrigerator is ideally suited for many tests that require a stable, cool temperature or general cold storage. The MPR-722 and 1412 comes regular in drawers, or with optional racks (MPR-722R or MPR-1412R).
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Laboratory Refrigerators
LPR-400
- Effective capacity
- 400L
- Temperature range
- +4℃ to +14℃
The safe and stable temperature control for cost-effectiveness.A refrigerator that is designed for general laboratory storage with user-friendly features. The combination of temperature control accuracy, interior temperature uniformity, quick recovery and resistance to high ambient temperature delivers a quality storage refrigerator that characterizes our commitment to engineering, storage safety and reliability.
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MPR-S150H (Energy Saving)
MPR-S300H (Energy Saving)
MPR-S500H (Energy Saving) |
MPR-N450FH (Energy Saving)
MPR-N450FSH*1 (Energy Saving) |
MPR-722 / MPR-722R*2
MPR-1412 / MPR1412R*2 |
LPR-400 |
| Brochure |
Brochure |
MPR-722 BrochureMPR-1412 Brochure |
Brochure |
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Manual |
MPR-722 / MPR-722R BrochureMPR-1412 / MPR-1412R Brochure |
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MPR Sliding Door Pharmaceutical Refrigerators
MPR-S163 | MPR-S313
- Effective capacity
- 158L / 340L
- Temperature range
- +2℃ to +14℃
The Pharmaceutical Refrigerators for reliable storage of pharmaceuticals, samples, and reagents.The MPR-S163 and MPR-S313 Pharmaceutical Refrigerator is compact but has a large capacity for reliable storage of pharmaceutical and medical supplies. The Medi-Cool lineup of medical refrigerators that are equipped with advanced cooling and electronic technology to provide precise temperature for the ideal preservation of medical supplies.
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MPR Pharmaceutical Refrigerator with Freezer
MPR-N250FH | MPR-N250FSH
- Effective capacity
- 179L (Ref) & 80L (Frz)
- Temperature range
- +2℃ to +14℃ (Ref) & -20℃ to -30℃ (Frz)
The complete storage solution – a refrigerator and freezer in one unit.The MPR-N250FH/MPR-N250FSH combine high-performance refrigeration with a -30°C freezing environment within a small footprint for flexible, reliable and convenient sample storage. Natural refrigerants minimize environmental impact for a sustainable storage solution. The MPR-N250 comes in either glass doors (FH) or solid steel doors (FSH).
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MPR Sliding Door Pharmaceutical Refrigerators
MPR-514 | MPR-1014
- Effective capacity
- 158L / 340L
- Temperature range
- +2℃ to +14℃
The uniform storage temperature for the most demanding applications.The +4°C MPR-514 and MPR-1014 Pharmaceutical Refrigerator offers a complete and integrated solution for the growing requirements for strict and exact storage temperatures for pharmaceuticals, medicines, and temperature sensitive biologicals at (2-14°C). The slim design and optional sliding shelves allows for an ergonomic easy-reach retrieval of your product. The MPR-514 and 1014 comes regular in drawers, or an optional racks (R).
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MPR-S163
MPR-S313 |
MPR-N250FH (Energy Saving)
MPR-N250FSH (Energy Saving) |
MPR-514 / MPR-514R*2
MPR-1014/ MPR-1014R*2 |
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| Brochure |
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| Manual |
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MPR-1014 Manual |
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*1 – FH: Fridge door with a glass window , FSH: Solid door type (without window) for the fridge part.
*2 - Large Capacity series have option of R (racks) or drawers.
PHCbi’s new sliding door pharmaceutical refrigerators, MPR-S300H and MPR-S150H, have improved the reduction of condensation on the glass doors. Condensation is typically caused by opening refrigerator doors too frequently, as the cool air from the equipment draws moisture out of nearby warmer air, then the moisture collects on the inside of the door surface. Condensation also causes lower thermal performance of refrigerators. Highly insulated argon gas-filled in glass panels on our new model ensures high-temperature performance and more visibility.
Cold Chain Solution
Case Study & Testimonial
The Center for Transfusion Medicine and Cell Therapy in Tokyo Medical and Dental UniversityThe Center for Transfusion Medicine and Cell Therapy in Tokyo Medical and Dental University, Medical Hospital is working on cell therapy and regenerative medicine in order to support and regenerate dysfunctional tissues and organs. The university established the Cell Processing Center (CPC) in 2002 for cell therapy and regenerative medicine.
The pioneering facility at the time that introduced CPC was established by Professor Tomohiro Morio, the former Center Chief. The center has three cell preparation rooms and one depressurized room in space of 100m2 which was designed and constructed by Sanyo Electric, the PHCbi predecessor.
Download Testimonial: The Center for Transfusion Medicine and Cell
National Center for Global Health and Medicine (NCGM) in Japan Huge freezers line the basement where the room temperature is kept low. This is the BioBank of the National Center for Global Health and Medicine (NCGM) in Shinjuku, Tokyo, where patients are examined and treated above ground, while in the basement lie the seeds of cutting-edge research.
The PHCbi freezers are where these seeds are stored. Read on to find out how they are being used and why they were selected for this facility. We interviewed Satoshi Suzuki, Manager of the BioBank Promotion Department, National Center for Global Health and Medicine.
Download Testimonial: National Center for Global Health and Medicine
HUB (Hubrecht Organoid Technology) in UtrechtUtrecht-based HUB wants to become the world’s leading organoid centre. More than 10 years after the cultivation of the first organoid – at the Hubrecht Institute by Toshiro Sato in the group headed by Hans Clevers – the path to commercial applications is open. So says Robert Vries, who has been working since 2013 to make HUB (Hubrecht Organoid Technology) the world’s leading organoid centre. At the core of this ambitious goal is the exclusive licence for the patents for making organoids out of adult stem cells, called ASC organoids.
Download Testimonial: Hubrecht Organoid Technology