GREEN8 Japan’s logistics service for regenerative medicine products realizes the safe and secure logistics of regenerative medicine products, such as cell sheets, tissues, and cell bank (WCB) vials. We can accommodate the temperature control needs, ranging from the liquid nitrogen temperature range (equivalent to -150°C or below) using dry shippers, and LN2 tanks, to the deep freezing temperature range of -80℃, as well as chilled temperature of +2 to +5℃
Liquid Nitrogen CRYO
Japan Domestic and International Network
24-Hour Support and Monitoring
GMP/GDP/GCTP Compliant
Life Science Logistics Servies
GREEN8 provides one-stop services both to storage, as well as transport and distribution of regenerative medicine in Japan with GMP/GDP/GCTP quality.
Temperature-Controlled Transport and Distribution
Compliant Temperature-Controlled Storage
Customs Clearance and Quarantine
Document Management
Cargo Insurance
Temperature-Controlled Logistics
Transport and Storage in 5 Temperature Ranges
Transport and storage are possible in 5 different temperature zones depending on the characteristics of reproductive medicine products. This flexibility maintains the stability of cargos and ensures reliability in providing them to patients.
Passive and Active Packing material
Appropriate temperature control is essential in transporting reproductive medicine products. Providing cold storage containers is part of this, and it is an indispensable measure for maintaining the quality of reproductive medicine products. GREEN8 Japan can prepare validated cold passive and active containers. Temperature loggers can also be provided at the same time for different range.
Liquid Nitrogen Transport from/to Japan
Domestic and international transport of regenerative medicine products in the liquid nitrogen temperature range is possible using dry shipper containers. GREEN8 uses IATA-certified dry shippers that maintain a stable cryogenic state (-150°C or below) for over 15 days by having a sponge built into the tank absorb the liquid nitrogen. GREEN8 has a track record of over 200 cryo transports annually, so please leave it to us with peace of mind.
Flow of Use
1. Inquiry and Request details
GREEN8 will ask in detail about the required temperature range, transport details, quantity of products, delivery time, etc.
2. Cost Quotation and Plan Proposal
GREEN8 will propose the optimal plan combining packaging formats, transport methods, and storage options if required.
3. Shipping Order and Payment
Once you have place an official shipping order and payment is arranged, designated account will be opened for the client and GREEN8 will begin transport and storage arrangements.
4. Transport and Storage
GREEN8 will monitor temperatures in real-time and execute transport and storage with immediate response in case of abnormalities. Each step of the transport as well as storage requests are updated to the client in timely manner.
5. Reports
After delivery/pickup is completed, GREEN8 will issue a Proof of Delivery and temperature records. We will also provide a temperature record of each transport if instructed for each shipment.
Record of transport and storage of Regenerative Medicine:
– Regenerative medicine
– Processed cells, cell-processed products/intermediates,
– IPS cells (induced pluripotent stem cells)
– ES cells (embryonic stem cells)
– Tissue stem cells, hematopoietic stem cells (HSCs), mesenchymal stem cells (MSCs), bone marrow stem cells, adipose-derived stem cells（ASCs）, somatic stem cells(Adult Stem Cells), neural stem cells(NSCs)
– Working Cell Banks (WCB)
– Human somatic cell processed products, anti-CD19 Chimeric Antigen Receptor (CAR) T-cells
– Human somatic stem cell processed products, regenerative medicine products for rare diseases, autologous cells (CAR T-cells)
– Allogeneic cells, cellular & gene therapy products, viral vector products, plasmid vector products
Compling with Health and Safety Guidelines
In the logistics of regenerative medicine products, compliance with the following laws, regulations, and guidelines is required. GREEN8 Japan provides regenerative medicine logistics services while also ensuring compliance. We also have required permits and licenses to store and distribute regenerative medicine in Japan.
Applicable Japan Regulation and permits:
-PMD Act; Pharmaceutical and Medical Device Act （Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices）（薬機法 ; 医薬品医療機器等法 ; 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律）/ Ministry of Health, Labour and Welfare
-ASRM (Act on the Safety of Regenerative Medicine）（再生医療等の安全性の確保等に関する法律）/ Ministry of Health, Labour and Welfare
– Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Regenerative Medical Products (GCTP Ministerial Ordinance)（再生医療等製品の製造管理及び品質管理の基準に関する省令） / Ministry of Health, Labour and Welfare
– G Guidelines for Transport of Human Cells and Tissues in R&D of Regenerative Medicine Products 2012 （再生医療分野細胞・組織加工品の研究・開発におけるヒト細胞・組織の搬送に関するガイドライン）/ Ministry of Economy, Trade and Industry
– Guidelines on Ensuring the Quality and Safety of Human (Autologous) iPS (like) Cell-Processed Products（ヒト（自己）iPS（様）細胞加工医薬品等の品質及び安全性の確保に関する指針） / Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
Temperature Record and Data for each transfer
Temperature data will be shared within 2 days after delivery is completed. GREEN8 can also provide temperature record according to client’s SOP requirement. We respond to the needs of medical institutions that want to verify quality before transplantation. Please contact our Quality Assurance team for details.
GMP/GDP/GCTP compliant Storage Depo in Japan with Regenerative Medicine Product Manufacturing License
GREEN8 Japan possesses a GMP depo facility compatible with Japan’s legal requirement for handling and storage of regenerative medicine products. GREEN8 ‘s GCTP compliant facility has an updated regenerative medicine storage and manufacturing license issued by PMDA.
GREEN8 Japan handles clients products with perfect quality, temperature settings, alerts in different temperature requirement , including liquid nitrogen tanks, with security and alert triggering system in case of any deviation.
Frequently Asked Questions (FAQ)
Q1. How many days does liquid nitrogen transport take?
A. Using containers that maintain -150°C or below for 10 days or more, we can transport within same day or next day delivery domestically in Japan, and about 2 to 7 business days internationally.
Q2. Is liquid nitrogen storage by the vial possible?
A. Yes, it is possible. Please be assured that we will handle everything consistently from transport to storage.
Q3. Is express transport from the collection point to the delivery destination possible?
A. We support transport within 48 hours. Please contact us as there are some areas where this is not possible depending on the delivery destination.
Inquiries and Free Consultations
To deliver valuable samples of regenerative medicine products safely and securely, please feel free to consult GREEN8 Japan customer support desk.
GREEN8 Japan will propose the optimal transport and storage plan and commit to maintaining quality.
